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Lutonix or Inpact for tHE tReatment Of fEmeropopliteal Stenosis - DCB (HEROES-DCB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02812966
Recruitment Status : Unknown
Verified March 2017 by Jaafer Golzar, Advocate Health Care.
Recruitment status was:  Recruiting
First Posted : June 24, 2016
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):
Jaafer Golzar, Advocate Health Care

Brief Summary:
Investigators hypothesize in patients presenting with significant peripheral arterial disease with clinical indications for treatment with angioplasty, there will be a difference in 12 month patency between the subjects with Lutonix 035 Drug coated Balloon PTA Catheter and IN.PACT Admiral Paclitaxel-Coated PTA Balloon Catheter.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: Lutonix Device: IN.PACT Not Applicable

Detailed Description:
Investigators hypothesize in patients presenting with significant peripheral arterial disease with clinical indications for treatment with angioplasty, there will be a difference in the 12 month patency (defined as PSVR <=2.4 at 12month follow-up visit with no TLR or target lesion bypass) between the subjects with Lutonix 035 Drug coated Balloon PTA Catheter and IN.PACT Admiral Paclitaxel-Coated PTA Balloon Catheter. Investigators will also assess and compare target lesion revascularization rates, safety profiles, adverse events, healthcare costs, and healthcare utilization.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lutonix or Inpact for tHE tReatment Of fEmeropopliteal Stenosis - DCB
Study Start Date : April 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Lutonix DCB
Lutonix 035 Drug coated Balloon PTA Catheter
Device: Lutonix
Drug Coated Balloons

Active Comparator: IN.PACT DCB
IN.PACT Admiral Paclitaxel-Coated PTA Balloon Catheter
Device: IN.PACT
Drug Coated Balloons




Primary Outcome Measures :
  1. Primary patency (Peak systolic velocity ratio<=2.4) [ Time Frame: 12 months ]
    Peak systolic velocity ratio<=2.4 (by duplex ultrasound scanning) with no target lesion revascularization or target lesion bypass


Secondary Outcome Measures :
  1. Target lesion revascularization rate [ Time Frame: 12 months ]


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:

  1. Patient is willing and able to provide informed consent, willing and agrees to comply with regular follow up visits, testing, medication regimen compliance any another treatments deemed necessary for treatment of vascular disease.
  2. Male or non-pregnant female
  3. Age greater >=18 years of age
  4. Patients with moderate to severe claudication or ischemic rest pain as defined by Rutherford 2-4 class symptoms
  5. >=1 tibial run-off vessel at baseline
  6. Angiographic criteria

    • >=70% stenosis (via visual angiographic estimate in the superficial femoral artery and/or popliteal arteries as appropriate)
    • 4-7mm vessel diameter
    • <=15cm for planned treatment segment length.
    • Planned treatment segments are to no further proximal than 1 cm from the bifurcation of the common femoral artery and no further distal than the 1 cm above the tibioperoneal trunk.
    • Lesions treated within the target vessel are either De Novo lesions or not previously stented restenotic segments of the superficial femoral artery and/or popliteal artery that are greater than 90 days from prior angioplasty procedure
    • If the target vessel was previously stented the treated lesion must be at least 3 cm from the previously placed stent
    • Lesion must be able to be treated with either drug coated balloon device based on the sizes specifications of both devices
    • Successful, uncomplicated crossing must be possible within the treated lesion either with or without a crossing device
    • Inflow artery must be free from significant occlusive disease (< 50%) as confirmed by visual estimation by angiography otherwise the inflow artery must be treated beforehand.
    • At least 1 patent vessel outflow from the target vessel treated must be present by angiography

Exclusion Criteria:

  1. Unable to meet clinical criteria to have peripheral angioplasty and follow-up treatment (lab values and pregnancy test)
  2. Contra-indicated to either DCB
  3. < 18 years of age at time of consent and/or index procedure
  4. Pregnant or Breast feeding
  5. In-stent restenosis within the target lesion
  6. Previously stented target lesion/vessel.
  7. Target lesion/vessel previously treated with drug-coated balloon <12 months prior to randomization/enrollment.
  8. Perforated vessel as evidenced by extravasation of contrast media prior to consent or enrollment.
  9. Presence of other hemodynamically significant outflow lesions in the target limb requiring intervention <=30 days of consent or randomization.
  10. Presence of aneurysm in the target vessel.
  11. Major amputation in the target limb.
  12. Subjects who have undergone prior surgery of the SFA/PPA in the target limb to treat atherosclerotic disease.
  13. Use of atherectomy, laser or other debulking devices in the target limb SFA/PPA during the index procedure.
  14. Acute ischemia and/or acute thrombosis of the SFA/PPA prior to consent or randomization.
  15. Known hypersensitivity or contraindication to contrast dye that, in the opinion of the local investigator, cannot be adequately pre-medicated.
  16. Known hypersensitivity/allergy to the investigational stent system or protocol related therapies.
  17. On dialysis or on an immunosuppressant therapy.
  18. Concomitant renal failure (including serum creatinine >2.0 mg/dL.)
  19. Occurrence of myocardial infarction (MI) or cerebrovascular accident (CVA) <=6 months prior to consent.
  20. Platelet count <80,000 mm3 or >600,000 mm3 or history of bleeding diathesis.
  21. Unstable angina pectoris at the time of consent or randomization.
  22. Septicemia at the time of consent or randomization.
  23. Moderate to severely calcified lesions.

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): NCT02812966


Contacts
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Contact: Chris Doherty, RN (708) 684-4618 christopher.doherty@advocatehealth.com

Locations
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United States, Illinois
Advocate Illinois Masonic Medical Center Recruiting
Chicago, Illinois, United States, 60657
Contact: Study Coordinator    773-537-0077      
Advocate Good Samaritan Hospital Recruiting
Downers Grove, Illinois, United States, 60515
Contact: Alice Szydlowska    630-785-2081    alicja.szydlowska@advocatehealth.com   
Advocate South Suburban Hospital Recruiting
Hazel Crest, Illinois, United States, 60429
Contact: Julie Hanrahan    708-213-5953    julie.hanrahan@advocatehealth.com   
Edward Hospital Recruiting
Naperville, Illinois, United States, 60540
Contact: Sherri McCoy    630-785-2243    sherri.mccoy@advocatehealth.com   
Advocate Christ Medical Center Recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Chris Doherty, RN    708-684-4618    christopher.doherty@advocatehealth.com   
Prairie Education and Research Collaborative Recruiting
Springfield, Illinois, United States, 62701
Contact: Reegan Hamrick    217-492-9100    rhamrick@prairieresearch.com   
Sponsors and Collaborators
Advocate Health Care
Investigators
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Principal Investigator: Jaafer Golzar, MD Advocate Health Care
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Responsible Party: Jaafer Golzar, MD, Advocate Health Care
ClinicalTrials.gov Identifier: NCT02812966    
Other Study ID Numbers: C5000163
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: March 24, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jaafer Golzar, Advocate Health Care:
peripheral arterial disease
drug coated balloon
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases