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Pantheris Atherectomy Treatment of In-Stent Restenosis In Lower Extremity Arteries (INSIGHT)

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ClinicalTrials.gov Identifier: NCT03192696
Recruitment Status : Recruiting
First Posted : June 20, 2017
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Avinger, Inc.

Brief Summary:
A prospective, non-randomized, international, multi-center study to evaluate the safety and effectiveness of the Pantheris OCT-Imaging System to perform atherectomy in In-Stent Restenotic (ISR) lesions in lower extremity arteries.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: Atherectomy Catheter Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: INSIGHT: EvaluatIoN of the PantheriS OCT- ImaGing AtHerectomy SysTem For Treatment of In-Stent Restenosis (ISR) Lesions In Lower Extremity Arteries
Actual Study Start Date : October 19, 2017
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Treatment Cohort
Atherectomy of in-stent restenosis
Device: Atherectomy Catheter
Treatment of restenotic lesions within stents previously placed within the artery.




Primary Outcome Measures :
  1. Freedom from a composite of major adverse events (MAEs) through 30-day follow-up (safety) [ Time Frame: Day 0 through 30 days post treatment procedure ]

    The primary safety endpoint is freedom from a composite of major adverse events (MAEs) through 30-day follow-up, as adjudicated by an independent CEC.

    Individual MAEs include:

    1. Cardiovascular-related death;
    2. Unplanned, major index limb amputation;
    3. Clinically driven target lesion revascularization (TLR);
    4. Myocardial infarction; or
    5. Device-associated events:

      1. Clinically significant perforation,
      2. Clinically significant dissection,
      3. Clinically significant embolus, or
      4. Pseudoaneurysm.

  2. Technical success of Pantheris catheter treatment (efficacy) device [ Time Frame: Day 0 ]
    The primary efficacy endpoint of technical success is defined as the percent of target lesions that have a residual diameter stenosis <50% post the Pantheris device alone, as assessed by an independent Angiographic Core Laboratory.


Secondary Outcome Measures :
  1. Stent structure freedom from new or worsening stent fracture post Pantheris treatment (safety) [ Time Frame: Day 0 ]
    Assess the stent for new or worsening stent fracture per comparative Pantheris OCT evaluation pre- and immediately post-procedure.

  2. Secondary Effectiveness Endpoint - Freedom from TLR [ Time Frame: 6 months post treatment procedure ]
    Freedom from TLR at 6 months as assessed by an independent CEC.

  3. Secondary Effectiveness Endpoint - Procedural Success [ Time Frame: Day 0 ]
    Procedural success defined as the percent of target lesions that have residual diameter stenosis ≤ 30% post-Pantheris and any other adjunctive therapy, determined by independent Angiographic Core Laboratory.

  4. Secondary Effectiveness Endpoint - Freedom from TLR [ Time Frame: 12 months post treatment procedure ]
    Freedom from TLR at 12 months as assessed by an independent CEC.

  5. Secondary Effectiveness Endpoint - Ankle-Brachial Index [ Time Frame: 30 days, 6 and 12 months post treatment procedure ]
    Ankle-Brachial Index at 30 days, 6 and 12 months

  6. Secondary Effectiveness Endpoint - Rutherford Classification [ Time Frame: 30 days, 6 and 12 months post treatment procedure ]
    Rutherford Classification at 30 days, 6 and 12 months

  7. Secondary Effectiveness Endpoint - Use Adjunctive Devices [ Time Frame: Day 0 ]
    Adjunctive devices (stent placement (bare metal or drug eluting stent), drug eluting balloon or other) utilized during the index procedure.



Information from the National Library of Medicine

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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

Inclusion Criteria:

  • Subject is >18 years old;
  • Subject is willing and able to give informed consent;
  • Subject has Rutherford Classification of I-V;
  • Subject presenting with a single Class I, II or III ISR lesion as per Tosaka's Classification criteria in the lower leg extremities;
  • Target lesion must be >70% stenosed and within a stented segment by angiographic visual estimation;
  • Reference vessel lumen acceptable for treatment with Pantheris catheter size as per visual angiographic estimation;
  • Target lesions must be within the stented segment and no more than 3 cm past the proximal or distal portions of the stent;
  • Target lesion is ≤30 cm in length;
  • Intraluminal crossing of totally occluded lesions prior to atherectomy;
  • At least one patent tibial run-off vessel at baseline; and
  • Subject is capable of meeting requirements and be present at the follow-up clinic visits at 30 days, 6 months and 12 months.

Exclusion Criteria:

  • Subject is pregnant or breast feeding;
  • Rutherford Class 0 or VI;
  • Severe calcification of the target lesion;
  • Acute ischemia and/or acute thrombosis of the target lesion segment;
  • Target lesion with a covered stent;
  • Target lesion in the iliac artery;
  • Target lesion stenosis <70%;
  • Target lesion >30 cm in length;
  • Subjects with totally occluded stented segments that are not successfully crossed intraluminally prior to atherectomy treatment;
  • Grade 4 or 5 stent fracture affecting target stent, or where evidence of stent protrusion into the lumen is noted on angiography in two orthogonal views;
  • Subjects on chronic hemodialysis or creatinine level >2.5 mg/dL;
  • CVA or stroke within 60 days prior to the index procedure;
  • Endovascular or surgical procedure performed on the index limb less than or equal to 30 days prior to the index procedure;
  • Planned endovascular or surgical procedure 30 days after the index procedure;
  • Lesion in the contralateral limb requiring intervention during the index
  • procedure or within 30 days of the index procedure;
  • Known allergy to contrast agents or medications used to perform endovascular
  • intervention that cannot be adequately pre-treated;
  • Subjects in whom anti-platelet, aspirin, anticoagulant, or thrombolytic therapy is contraindicated;
  • Any thrombolytic therapy within 2 weeks of the index procedure;
  • Any clinical and/or angiographic complication attributed to the use of another device prior to the insertion of the study device into the subject during the index procedure;
  • Subjects or their legal guardians who have not or will not sign the Informed Consent;
  • Subjects who are unwilling or unable to comply with the follow-up study
  • requirements; or
  • Participation in any study of an investigational device, medication, biologic or other agent within 30 days prior to enrollment that is either a cardiovascular study or could, in the judgment of the investigator, affect the results of the study.

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): NCT03192696


Contacts
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Contact: Ruth Lira, BS 650-241-7900 rlira@avinger.com
Contact: Thomas Lawson, PhD 650-241-7030 tlawson@avinger.com

Locations
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United States, Arizona
Phoenix Heart Center Not yet recruiting
Phoenix, Arizona, United States, 85006
Contact: Renata Schwartz, MBA, RN, BSN    602-251-8890    Renata.Schwartz@steward.org   
Principal Investigator: Ajay Mhatre, MD         
United States, Arkansas
St. Bernards Medical Center Not yet recruiting
Jonesboro, Arkansas, United States, 72401
Contact: Kayla Rubino, LPN    870-935-6729    krubino@stbheart.com   
Principal Investigator: Barry Tedder, MD         
Arkansas Heart Hospital Recruiting
Little Rock, Arkansas, United States, 72211
Contact: Mary Catherine Faulkner    501-748-8421    marycatherine.faulkner@arheart.com   
Contact: Jennifer Payne       Jennifer.Payne@arheart.com   
Principal Investigator: Ian Cawich, MD         
United States, California
University of California San Diego (UCSD) Not yet recruiting
San Diego, California, United States, 92037
Contact: Bahman Ghannadian, MD    858-246-2360    bghannadian@ucsd.edu   
Principal Investigator: Mitul Patel, MD         
United States, Illinois
Advocate Christ Hospital and Medical Center Not yet recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Christopher Doherty, RN    708-684-4618    christopher.doherty@advocatehealth.com   
Principal Investigator: Jaafer Golzar, MD         
United States, Louisiana
Baton Rouge General Medical Center Recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: Stacie LaPrarie, RN    225-237-1673    Stacie.laprarie@brgeneral.org   
Contact: Jane Byrne    225-237-1674    jane.byrne@brgeneral.org"   
Principal Investigator: Glen Schwartzberg, MD         
United States, Missouri
University of Missouri Not yet recruiting
Columbia, Missouri, United States, 65212
Contact: Jill Akers, LPN    573-882-0177    akersji@health.missouri.edu   
Principal Investigator: Todd Vogel, MD         
United States, New Jersey
Deborah Heart and Lung Center Not yet recruiting
Browns Mills, New Jersey, United States, 08015
Contact: Linda Dewey, RN    609-893-1200 ext 5023    deweyl@deborah.org   
Principal Investigator: Vincent Varghese, DO         
United States, Ohio
TriHealth-Hatton Research Institute Not yet recruiting
Cincinnati, Ohio, United States, 45220
Contact: Lori Reid, MSN, RN, CCRC    (513)862-5124    lori_reid@trihealth.com   
Principal Investigator: Patrick Muck, MD         
Dayton Heart Center Not yet recruiting
Dayton, Ohio, United States, 45414
Contact: Chris Weller, RN, CCRC    937-276-8784 ext 3187    cweller@premierhealth.com   
Contact: Jeff Gluck, PHS    937-276-8784 ext 3152    jfgluck@premierhealth.com   
Principal Investigator: Gary J. Fishbein, MD, FACC         
United States, Pennsylvania
Einstein Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19141
Contact: Rachel Murphy    215-456-1959    MurphyRa@einstein.edu   
Contact: Kinnari Murthy, MPH    215-456-6736    MurthyK@einstein.edu   
Principal Investigator: Sean Janzer, MD         
Sub-Investigator: Jon George, MD         
United States, Tennessee
University of Tennessee Health Science Center Not yet recruiting
Memphis, Tennessee, United States, 38163
Contact: Carol Hendrix    901-448-2478    chendri6@uthsc.edu   
Principal Investigator: Dwight Dishmon, MD         
United States, Texas
Cardiovascular Associates of East Texas Not yet recruiting
Tyler, Texas, United States, 75701
Contact: Elizabeth Olson    903-595-2283    eolson@caet.net   
Principal Investigator: Jeffrey Carr, MD         
Sponsors and Collaborators
Avinger, Inc.

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Responsible Party: Avinger, Inc.
ClinicalTrials.gov Identifier: NCT03192696     History of Changes
Other Study ID Numbers: P0942
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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: Yes
Pediatric Postmarket Surveillance of a Device Product: No

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