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Trial record 6 of 8 for:    lithoplasty

Shockwave Medical Peripheral Lithoplasty System Study for PAD (Disrupt PAD III)

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ClinicalTrials.gov Identifier: NCT02923193
Recruitment Status : Recruiting
First Posted : October 4, 2016
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Shockwave Medical, Inc.

Brief Summary:

Shockwave Medical Inc. intends to conduct a prospective, multi-center, single blind, randomized (1:1) study of Lithoplasty treatment used in combination with DCB versus standard balloon angioplasty used in combination with DCB to treat moderate and severely calcified femoropopliteal arteries. Assuming that roughly 15% of the subjects will be lost-to-follow-up, a total of up to 400 subjects (200 per treatment arm) will be enrolled in the study at up to 60 sites in Europe, the United States and New Zealand.

In addition to the randomized study, an observational study of subjects who do not meet the inclusion/exclusion criteria for the randomized study will be conducted. The objective of the observational study is to assess the real-world acute performance of the Shockwave Medical Peripheral Lithoplasty System in the treatment of calcified, stenotic, peripheral arteries.

The observational study is a prospective, multi-center, single arm observational study for subjects who do not meet the inclusion/exclusion criteria of the randomized study.

A maximum of 1000 subjects at the same 60 sites will be enrolled in the observational study. Once enrollment in the randomized portion of the study is complete, subjects may continue to be enrolled in the observational study provided they meet OS eligibility criteria.


Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: Shockwave Lithoplasty® Peripheral Lithoplasty System Drug: Medtronic IN.PACT (DCB) Not Applicable

Detailed Description:

Shockwave Medical Inc. intends to conduct a prospective, multi-center, single blind, randomized (1:1) study of Lithoplasty treatment used in combination with DCB versus standard balloon angioplasty used in combination with DCB to treat moderate and severely calcified femoropopliteal arteries. The Shockwave Medical Peripheral Lithoplasty System is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of calcified, stenotic peripheral arteries in patients who are candidates for percutaneous therapy. Up to 400 subjects at 60 sites in Europe, the United States and New Zealand.

Subjects will be followed through discharge, 30 days, and 6, 12 and 24 months. DUS assessments will be completed at 12 and 24 months. Procedural success is defined as residual stenosis ≤30% without flow-limiting dissection (≥ grade D) prior to DCB or stenting by angiographic core lab.

Subjects who do not meet the randomized study inclusion and exclusion criteria, but meet the inclusion and exclusion criteria for the observational study may be enrolled in the observational study. The objective of the observational study is to assess the real-world acute performance of the Shockwave Medical Lithoplasty System in the treatment of calcified, stenotic, peripheral arteries.The observational study is a prospective, multi-center, single arm observational study for subjects who do not meet the inclusion/exclusion criteria of the randomized study. A maximum of 1000 subjects at the same 60 sites will be enrolled in the observational study. Procedural success defined as residual stenosis <30% prior to DCB or stenting by angiographic core lab. Enrollment in the observational study is anticipated to last approximately 16 months. Subjects in the observational study will be followed through hospital discharge. Once enrollment in the randomized portion of the study is complete, subjects may continue to be enrolled in the observational study provided they meet OS eligibility criteria.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Study of the Shockwave Medical Peripheral Lithoplasty® System Used in Combination With DCB Versus Standard Balloon Angioplasty Used in Combination With DCB to Treat Moderate and Severely Calcified Femoropopliteal Arteries
Actual Study Start Date : February 22, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Arm Intervention/treatment
Experimental: Lithoplasty System followed by DCB
Shockwave Lithoplasty® Peripheral Lithoplasty System is a lithotripsy-enhanced, low-pressure balloon dilatation of calcified, stenotic peripheral arteries in patients who are candidates for percutaneous therapy. lithoplasty
Device: Shockwave Lithoplasty® Peripheral Lithoplasty System
The Shockwave Lithoplasty® System is a proprietary lithotripsy-enhanced balloon catheter that is designed to be delivered through the peripheral arterial system of the lower extremities to the site of calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy electrodes, and a generator.

Drug: Medtronic IN.PACT (DCB)
The IN.PACT Admiral DCB is an over-the-wire (OTW) balloon catheter with a drug-coated balloon at the distal tip. The drug component, referred to as the FreePac™ drug coating, consists of the drug paclitaxel and the excipient urea. The device component physically dilates the vessel lumen by PTA, and the drug is intended to reduce the proliferative response that is associated with restenosis.
Other Name: drug coated balloon

Active Comparator: Medtronic IN.PACT (DCB)
Medronic IN.PACT Drug Coated Balloon (DBS) is indicated for percutaneous transluminal angioplasty (PTA) in patients with obstructive disease of peripheral arteries, including patients with in-stent restenosis (ISR) and arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease.
Drug: Medtronic IN.PACT (DCB)
The IN.PACT Admiral DCB is an over-the-wire (OTW) balloon catheter with a drug-coated balloon at the distal tip. The drug component, referred to as the FreePac™ drug coating, consists of the drug paclitaxel and the excipient urea. The device component physically dilates the vessel lumen by PTA, and the drug is intended to reduce the proliferative response that is associated with restenosis.
Other Name: drug coated balloon




Primary Outcome Measures :
  1. Procedural success is defined as residual stenosis ≤30% without flow-limiting dissection (≥ grade D) prior to DCB or stenting by angiographic core lab. [ Time Frame: Peri-Procedural ]
    Procedural success is defined as residual stenosis ≤30% without flow-limiting dissection (≥ grade D) prior to DCB or stenting by angiographic core lab.


Secondary Outcome Measures :
  1. Primary patency defined as freedom from clinically-driven target lesion revascularization (TLR) and freedom from restenosis determined by duplex ultrasound or angiogram greater than or equal to 50% stenosis. [ Time Frame: Peri-Procedural ]
    acute PTA failure requiring a stent at any time during the index procedure will be counted as a TLR at day 0, and loss of primary patency.

  2. Composite of new-onset Major Adverse Events (MAEs) [ Time Frame: Within 30 days, 6, 12 and 24 months post procedure ]

    Need for emergency surgical revascularization of target limb

    • Unplanned target limb major amputation (above the ankle)
    • Symptomatic thrombus or distal emboli that require surgical, mechanical or pharmacologic means to improve flow and extend hospitalization
    • Perforations that require an intervention, including bail-out stenting

  3. Primary patency [ Time Frame: 30 days, 6, 12 and 24 months ]
    defined as freedom from clinically-driven target lesion revascularization (TLR)

  4. Clinical Success ABI [ Time Frame: 30 days, 6, 12 and 24 months ]
    defined as ankle-brachial index ABI reported as change from baseline

  5. Clinical Success Rutherford Category [ Time Frame: 30 days, 6, 12 and 24 months ]
    defined as Rutherford Category reported as change from baseline

  6. Clinical Success Quality of Life [ Time Frame: 30 days, 6, 12 and 24 months ]
    defined by Quality of Life assessed by EQ5D questionnaire reported as change from baseline



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Randomized Study Arm Eligibility Criteria

General Inclusion Criteria

  1. Subject is able and willing to comply with all assessments in the study.
  2. Subject or subject's legal representative have been informed of the nature of the study, agrees to participate and has signed the approved consent form.
  3. Age of subject is greater than or equal to 18.
  4. Rutherford Clinical Category 2, 3, or 4 of the target limb.
  5. Estimated life expectancy >1 year.
  6. Subject is a suitable candidate for angiography and endovascular intervention in the opinion of the investigator or per hospital guideline.
  7. Subject is intended to undergo treatment with Lithoplasty followed by DCB, or DCB with standard balloon pre-dilatation.

    Angiographic Inclusion Criteria

  8. Target lesion that is located in a native, de novo superficial femoral artery (SFA) or popliteal artery (popliteal artery extends to and ends proximal to the ostium of the anterior tibial artery).
  9. Target lesion reference vessel diameter is between 4.0mm and 7.0mm by visual estimate.
  10. Target lesion is ≥70% stenosis by investigator via visual estimate.
  11. Target lesion length is ≤180mm for lesions 70-99% stenosed. Target lesion can be all or part of the 180mm treated zone.
  12. Chronic total occlusion, lesion length is ≤100mm of the total ≤180 mm target lesion.
  13. Subject has at least one patent tibial vessel on the target leg with runoff to the foot, defined as no stenosis >50%.
  14. Calcification is at least moderate defined as presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending > 50% the length of the lesion if lesion is ≥50mm in length; or extending for minimum of 20mm if lesion is <50mm in length.

General Exclusion Criteria

  1. Rutherford Clinical Category 0, 1, 5 and 6.
  2. Subject has active infection requiring antibiotic therapy.
  3. Planned target limb major amputation (above the ankle).
  4. History of prior endovascular or surgical procedure on the index limb within the past 30 days or planned within 30 days of the index procedure.
  5. Subject has a known coagulopathy or has bleeding diatheses, thrombocytopenia with platelet count less than 100,000/microliter.
  6. Subject in whom antiplatelet or anticoagulant therapy is contraindicated.
  7. Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
  8. Subject has known allergy to urethane, nylon, or silicone.
  9. Myocardial infarction within 60 days prior to enrollment.
  10. History of stroke within 60 days prior to enrollment.
  11. History of thrombolytic therapy within two weeks of enrollment.
  12. Subject has acute or chronic renal disease defined as serum creatinine of >2.5 mg/dL or >220 umol/L, or on dialysis.
  13. Subject is pregnant or nursing.
  14. Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
  15. Subject has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment.
  16. The use of specialty balloons, re-entry or atherectomy devices.

    Angiographic Exclusion Criteria

  17. In-stent restenosis within 10mm of the target zone.
  18. Lesions within 10mm of the ostium of the SFA or within 10mm of the ostium of the anterior tibial artery.
  19. Evidence of aneurysm or thrombus in target vessel.
  20. No calcium or mild calcium in the target lesion.
  21. Target lesion within native or synthetic vessel grafts.
  22. Subject has significant stenosis (>50% stenosis) or occlusion of inflow tract before target treatment zone (e.g. iliac or common femoral) not successfully treated.
  23. Subject requires treatment of a peripheral lesion on the ipsilateral limb distal to target site at the time of the index procedure.
  24. Failure to successfully cross the guidewire across the target lesion; successful crossing defined as tip of the guidewire distal to the target lesion in the absence of flow limiting dissections or perforations.

Subjects who do not meet the inclusion/exclusion criteria for the randomized study may satisfy the eligibility criteria for the observational study.

Observational Study Eligibility Criteria

Inclusion Criteria

  1. Subjects intended to be treated with the Shockwave Medical Peripheral Lithoplasty® System for de-novo or restenotic lesions of the femoral, ilio-femoral, popliteal, and infra-popliteal arteries.
  2. Subjects presenting with claudication or CLI by Rutherford Clinical Category 2,3,4,5, or 6 of the target limb.
  3. Age of subject is > 18.
  4. Subject or subject's legal representative have been informed of the nature of the study, agrees to participate, and has signed the approved study consent form.
  5. Calcification is at least moderate, defined as presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending > 50% the length of the lesion if lesion is ≥50mm in length; or extending for minimum of 20mm if lesion is <50mm in length.

Exclusion Criteria

  1. Subjects with any medical condition that would make him/her an inappropriate candidate for treatment with Shockwave Medical Peripheral Lithoplasty® System as per Instructions for Use (IFU) or investigator's opinion.
  2. Subject is already enrolled in other investigational (interventional) studies that would interfere with study endpoints.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02923193


Contacts
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Contact: Alexis Brash 1-510-624-9093 abrash@shockwavemedical.com

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Locations
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United States, Arizona
Abrazo Arizona Heart Hospital Recruiting
Phoenix, Arizona, United States, 85016
Contact: Patricia Ames    602-674-1436    pames@abrazohealth.com   
Principal Investigator: Venkatesh Ramaiah, MD         
Sub-Investigator: Ayman Jamal, MD         
Sub-Investigator: Sherise Warren, DO         
United States, Arkansas
Arkansas Heart Hospital Recruiting
Little Rock, Arkansas, United States, 72211
Contact: Mary Catherine Faulkner    501-748-8421    MaryCatherine.Faulkner@arheart.com   
Principal Investigator: Ian Cawich, MD         
United States, California
Stanford Hospital Recruiting
Palo Alto, California, United States, 94304
Contact: Tiffany Flores    650-725-8718    Tflores2@Stanford.edu   
Principal Investigator: Claire A Watkins, MD         
Sub-Investigator: Venita Chandra         
Sub-Investigator: Ron Dalman         
Sub-Investigator: E. John Harris         
Sub-Investigator: Jason Lee         
United States, Colorado
Rocky Mountain Regional VA Medical Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Michele Corbet    720-723-6418    michele.corbet@ucdenver.edu   
Principal Investigator: Ehrin Armstrong, MD         
UCHealth Northern Colorado Recruiting
Loveland, Colorado, United States, 80538
Contact: Adam Jaskowiak    970-624-1688    adam.jaskowiak@uchealth.org   
Principal Investigator: William Miller, MD         
Sub-Investigator: Philip Dattilo         
United States, Connecticut
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
Contact: Dawn Shaddinger, RN    203-737-3570    dawn.shaddinger@yale.edu   
Principal Investigator: Carlos Mena, MD         
Sub-Investigator: Robert Attaran         
Sub-Investigator: S. Elissa Altin         
Sub-Investigator: Glen Henry         
Sub-Investigator: Sasanka Jayasuriya         
United States, District of Columbia
MedStar Cardiovascular Research Network @ Medstar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Suman Singh    202-877-8475    Suman.Singh@medstar.net   
Principal Investigator: Tareq Massimi, MD         
Sub-Investigator: Steven Abramowitz         
Sub-Investigator: Nelson Bernardo         
Sub-Investigator: Rajesh Malik         
Sub-Investigator: Edward Woo         
United States, Florida
Tallahassee Research Institute, Inc. Recruiting
Tallahassee, Florida, United States, 32308
Contact: Rebecca Plasay    850-431-5024    rebecca.plasay@tmh.org   
Principal Investigator: William Dixon, MD         
United States, Georgia
Piedmont Heart Institute Recruiting
Atlanta, Georgia, United States, 30309
Contact: Festus Oyedokun    404-605-2327    Festus.oyedokun@piedmont.org   
Principal Investigator: Andrew Klein, MD         
Sub-Investigator: David Kandzari         
Sub-Investigator: Prashant Kaul         
Sub-Investigator: Charles Ross         
Sub-Investigator: Andrew Unzeitig         
Northeast Georgia Medical Center Recruiting
Gainesville, Georgia, United States, 30501
Contact: Donna Patrick    678-989-5001    donna.patrick@nghs.com   
Principal Investigator: Jeff Marshall, MD         
Sub-Investigator: Allison Dupont         
Sub-Investigator: Christopher Leach         
Sub-Investigator: Mark Leimbach         
Sub-Investigator: James Reeves         
Sub-Investigator: Pradymna Tummala         
Sub-Investigator: Andrew Yen         
United States, Illinois
Alexian Brothers Medical Center Recruiting
Elk Grove Village, Illinois, United States, 60007
Contact: April Levesque       april.levesque@amitahealth.org   
Principal Investigator: Jack Chamberlin, MD         
Sub-Investigator: Atif Baqai         
Sub-Investigator: Firas Barrow         
Sub-Investigator: Paul Grunenwald         
Sub-Investigator: Saba Khan         
Sub-Investigator: Andrei Pop         
Sub-Investigator: Bharat Samy         
Advocate Health and Hospitals Corporation Recruiting
Oakbrook Terrace, Illinois, United States, 60181
Contact: Kim Paprockas       kimberly.paprockas@advocatehealth.com   
Principal Investigator: Mark Goodwin, MD         
Sub-Investigator: Pratik Parikh         
Sub-Investigator: Mahesh Raju         
Sub-Investigator: Anand Ramanathan         
Sub-Investigator: Sourabh Mukherjee         
Prairie Education & Research Cooperative Recruiting
Springfield, Illinois, United States, 62769
Contact: Kelse Mather    217-492-9100 ext 29122    kmather@prairieresearch.com   
Principal Investigator: Nilesh J. Goswami, M.D.         
Sub-Investigator: Jeffrey Goldstein         
Sub-Investigator: Gabor Matos         
United States, Iowa
Midwest Cardiovascular Research Foundation Recruiting
Davenport, Iowa, United States, 52803
Contact: John Shammas    563-324-2828 ext 108    shammasw@mcrfmd.com   
Principal Investigator: Nicholas Shammas, MD         
United States, Maine
Steward St. Elizabeth's Medical Center Recruiting
Brighton, Maine, United States, 02135
Contact: Rina Vaquerano    617-789-3041    rina.vaquerano@steward.org   
Principal Investigator: Lawrence Garcia, MD         
United States, Michigan
Ascension / St. John Hospital and Medical Center Withdrawn
Detroit, Michigan, United States, 48236
St. Joseph Mercy Oakland Recruiting
Pontiac, Michigan, United States, 48431
Contact: Lynn Boomer    248-858-3756    lynn.boomer@stjoeshealth.org   
Principal Investigator: Kirit Patel, MD         
Ascension / St. John Providence Recruiting
Southfield, Michigan, United States, 48075
Contact: Jean Kelly    248-849-3369    jean.kelly@ascension.org   
Principal Investigator: Patrick Alexander, MD         
United States, Mississippi
North Mississippi Medical Center Recruiting
Tupelo, Mississippi, United States, 38801
Contact: Marsha Jones    662-377-7456    mrjones@nmhs.net   
Principal Investigator: Barry Bertolet, MD         
Sub-Investigator: Joseph Stinson         
United States, Missouri
Saint Luke's Cardiovascular Consultants Recruiting
Kansas City, Missouri, United States, 64111
Contact: Lisa Lacey    816-932-7528    lnewhouse@saint-lukes.org   
Principal Investigator: Steven Laster, MD         
Sub-Investigator: Matthew Bunte         
Sub-Investigator: Jason Lindsey         
Sub-Investigator: David Safley         
Sub-Investigator: Adam Salisbury         
Saint Louis University Withdrawn
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Deborah Heart and Lung Center Recruiting
Browns Mills, New Jersey, United States, 08015
Contact: Linda Dewey    609-893-1200 ext 5023    deweyl@deborah.org   
Principal Investigator: Vince Varghese, MD         
United States, New Mexico
New Mexico Heart Institute Recruiting
Albuquerque, New Mexico, United States, 87102
Contact: Amy Bird    505-843-2802    amya@nmhi.com   
Principal Investigator: Steve Henao, MD         
Sub-Investigator: Trent Proffitt         
Sub-Investigator: Richard Wilkerson         
United States, New York
Mount Sinai West Recruiting
New York, New York, United States, 10019
Contact: Ruslan Mull    212-523-8353    ruslan.mull@mountsinai.org   
Principal Investigator: James McKinsey, MD         
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Miguel Vasquez       miguel.vasquez@mountsinai.org   
Principal Investigator: Prakash Krishnan, MD         
Sub-Investigator: Karthik Gujja         
Sub-Investigator: Vishal Kapur         
Columbia University Medical Center/New York Presbyterian Hospital Recruiting
New York, New York, United States, 10032
Contact: Kate Dalton    347-514-3366    keb2114@cumc.columbia.edu   
Principal Investigator: Sahil Parikh, MD         
Sub-Investigator: Phil Green         
Sub-Investigator: Ajay Kirtane         
Sub-Investigator: Anthony Pucillo         
United States, North Carolina
NC Heart & Vascular Research Recruiting
Raleigh, North Carolina, United States, 27607
Contact: Gabriel Brandner    919-784-3413    gabriel.brandner@unchealth.unc.edu   
Principal Investigator: George Adams, MD         
Sub-Investigator: Dorian DeFreitas         
Sub-Investigator: Pratik Desai         
Sub-Investigator: Brian Go         
Sub-Investigator: Jason Kim         
Sub-Investigator: Martyn Knowles         
Sub-Investigator: Robert Mendes         
Sub-Investigator: Liliana Nanez         
Sub-Investigator: Ravish Sachar         
Sub-Investigator: James Zidar         
WakeMed Heart Center Recruiting
Raleigh, North Carolina, United States, 27610
Contact: Annsley Winders    919-231-6132 ext 425    awinders@wakemed.org   
Principal Investigator: Siddhartha Rao, MD         
United States, Ohio
Ohio Health Research Institute Recruiting
Columbus, Ohio, United States, 43214
Contact: Johnna Booker    614-566-1272    Johnna.Booker@ohiohealth.com   
Principal Investigator: John A Phillips, MD         
Principal Investigator: Gary Ansel, MD         
Sub-Investigator: Charles Botti         
Sub-Investigator: Mitchell Silver         
Sub-Investigator: Michael Jolly         
United States, Oklahoma
St. John Clinic Recruiting
Bartlesville, Oklahoma, United States, 74006
Contact: Mary Harris, RN    918-322-3616    mary.harris@ascension.org   
Principal Investigator: Anderson Mehrle, MD         
Sub-Investigator: Mollie Bechtelheimer         
Sub-Investigator: Andrew Kurklinsky         
United States, Oregon
Providence Heart & Vascular Institute Recruiting
Portland, Oregon, United States, 97225
Contact: Gretchen Sminkey       gretchen.sminkey@providence.org   
Principal Investigator: Ethan Korngold, MD         
Sub-Investigator: Charles Cannan         
Sub-Investigator: Brandon Jones         
Sub-Investigator: Aditi Madabhushi         
Sub-Investigator: Alejandro Perez         
Sub-Investigator: Vincent Santo         
Sub-Investigator: Brant Ullery         
United States, Pennsylvania
PinnacleHealth Harrisburg Hospital Recruiting
Harrisburg, Pennsylvania, United States, 17101
Contact: Gretchen Meise    717-920-4400 ext 4280    GMeise@PINNACLEHEALTH.org   
Principal Investigator: William Bachinsky, MD         
Sub-Investigator: David Chang         
Sub-Investigator: Cleon Hubbard         
Sub-Investigator: David Loran         
Sub-Investigator: Anay Pradhan         
PENN Presbyterian Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Elizabeth Medenilla    215-662-9084    Elizabeth.Medenilla@uphs.upenn.edu   
Principal Investigator: Arthur Topoulos, MD         
Sub-Investigator: Robert Fenning         
Sub-Investigator: Alan Moak         
Einstein Medical Center Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19141
Contact: Kinnari Murthy    215-456-1959    murthyK@einstein.edu   
Principal Investigator: Sean Janzer, MD         
Sub-Investigator: Jon George         
PinnacleHealth Cardiovascular Institute Recruiting
Wormleysburg, Pennsylvania, United States, 17043
Contact: Gretchen Meise    717-920-4400 ext 4280    GMeise@PINNACLEHEALTH.org   
Principal Investigator: William Bachinsky, MD         
Sub-Investigator: David Chang         
Sub-Investigator: Cleon Hubbard         
Sub-Investigator: David Loran         
Sub-Investigator: Anay Pradhan         
Lankenau Heart Center Recruiting
Wynnewood, Pennsylvania, United States, 19096
Contact: Ann Marie Chikowski    484-476-8579    ChikowskiA@mlhs.org   
Principal Investigator: Sarang Mangalmurti, MD         
Sub-Investigator: Antonis Pratsos         
Sub-Investigator: Willaim Gray         
United States, Rhode Island
The Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact: Lina Felix, RN    401-793-4105    lfelix@lifespan.org   
Principal Investigator: Peter Soukas, MD         
Sub-Investigator: Omar Hyder         
Sub-Investigator: Shafiq Mamdani         
United States, South Dakota
Vascular Associates Recruiting
Sioux Falls, South Dakota, United States, 57105
Contact: Karla Reilly    605-312-7329    karla.reilly@sanfordhealth.org   
Principal Investigator: Angelos Santos         
United States, Tennessee
Wellmont CVA Heart Institute Recruiting
Kingsport, Tennessee, United States, 37660
Contact: Brandy Venable    423-230-5618    brandy.venable@balladhealth.org   
Principal Investigator: Christopher Metzger, MD         
Sub-Investigator: Mark Aziz         
Tennova Healthcare - Turkey Creek Medical Center Recruiting
Knoxville, Tennessee, United States, 37934
Contact: Constance Bales, RN    865-218-7539    constance.bales@tennova.com   
Principal Investigator: Malcolm Foster III, MD, FACC         
Sub-Investigator: Mukesh Sharma, MD         
Baptist Medical Center Recruiting
Memphis, Tennessee, United States, 38120
Contact: Amber Turner    901-747-1268    amber@cvsclinic.com   
Principal Investigator: Edward Garrett, MD         
United States, Texas
St. David's Heart and Vascular dba Austin Heart Recruiting
Austin, Texas, United States, 78757
Contact: Agnieszka "Nishka" Marczak       agnieszka.marczak@hcahealthcare.com   
Principal Investigator: Roger Gammon, MD         
Sub-Investigator: Mark Picone         
Sub-Investigator: Matt Selmon         
Sub-Investigator: Frank Zidar         
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Ana Enriquez    713-798-7537    ana.enriquez@bcm.edu   
Principal Investigator: Miguel Montero, MD         
United States, West Virginia
Charleston Area Medical Center Recruiting
Charleston, West Virginia, United States, 25304
Contact: Briana Knapp    304-388-9956    Briana.knapp@camc.org   
Principal Investigator: Aravinda Nanjundappa, MD         
Sub-Investigator: Albeir Mousa         
Austria
Medizinische Universitaet Graz Recruiting
Graz, Austria, 8036
Contact: Gabi Platzer       Gabriele.Platzer@klinikum-graz.at   
Principal Investigator: Marianne Brodmann, MD         
Hanusch Krankenhaus Recruiting
Vienna, Austria, 1140
Principal Investigator: Martin Werner, MD         
Germany
Karolinen-Hospital Recruiting
Arnsberg, Germany, 59759
Contact: Simone Mueller       si.mueller@studynurse-si.de   
Principal Investigator: Michael Lichtenberg, MD         
Universitäts-Herzzentrum Freiburg & Bad Krozingen Recruiting
Bad Krozingen, Germany, 79189
Contact: Verena Zähringer       verena.zaehringer@universitaets-herzzentrum.de   
Principal Investigator: Thomas Zeller, MD         
Sankt Gertrauden-Krankenhaus Recruiting
Berlin, Germany, 10713
Contact: Heike Bütow       Heike.Buetow@sankt-gertrauden.de   
Principal Investigator: Ralf Langhoff, MD         
International Center for Cardiovascular Interventions (ICCI) Recruiting
Bonn, Germany, 53105
Contact: Tanja Streuber       tanja.streuber@ukb.uni-bonn.de   
Sub-Investigator: Nikos Werner, MD         
Leiter Sektion Angiologie Recruiting
Bonn, Germany, 53127
Contact: Tanja Streuber       tanja.streuber@ukb.uni-bonn.de   
Principal Investigator: Nadjib Schahab, MD         
Principal Investigator: Nikos Werner, MD         
Medizinische Klinik II Recruiting
Bruchsal, Germany, 76646
Contact: Manuela Scherer-Stolz       manuela.scherer-stolz@kliniken-lk.de   
Principal Investigator: Martin Andrassy, MD         
Klinik für Gefäßmedizin Recruiting
Hamburg, Germany, 22527
Contact: Nicole Fentroß       n.fentross@asklepios.com   
Principal Investigator: Hans Krankenberg, MD         
Universitätsklinikum Leipzig AoR Leipzig Recruiting
Leipzig, Germany, 04103
Contact: Janine Brunotte       janine.brunotte@medizin.uni-leipzig.de   
Principal Investigator: Dierk Scheinert, MD         
Sub-Investigator: Franka Borger, MD         
Katholisches Klinikum Mainz Recruiting
Mainz, Germany, 55131
Contact: Bärbel Kaesberger       j-balzer@kkmainz.de   
Principal Investigator: John O Balzer, MD         
St. Franziskus Hospital Recruiting
Munster, Germany
Contact: Christiane Hericks       christiane.hericks@sfh-muenster.de   
Principal Investigator: Arne Schwindt, MD         
Evangelisches Krankenhaus Mühlheim an der Ruhr Recruiting
Mülheim, Germany, 45468
Contact: Jennifer Dinter       jennifer.dinter@evkmh.de   
Principal Investigator: Claus Nolte-Ernsting, MD         
RoMed Klinikum Rosenheim Recruiting
Rosenheim, Germany
Contact: Erika Rinser       erika.rinser@ro-med.de   
Principal Investigator: Gunnar Tepe, MD         
New Zealand
Auckland City Hospital Recruiting
Auckland, New Zealand
Contact: Donna Katae       DKatae@adhb.govt.nz   
Principal Investigator: Andrew Holden, MD         
Sub-Investigator: Andrew Hill         
Sponsors and Collaborators
Shockwave Medical, Inc.
Investigators
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Principal Investigator: Gunnar Tepe, MD RoMed Klinikum Rosenheim
Principal Investigator: William A Gray, MD Main Line Health

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Responsible Party: Shockwave Medical, Inc.
ClinicalTrials.gov Identifier: NCT02923193     History of Changes
Other Study ID Numbers: CP 60892
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases