Last updated on November 2019

IN.PACT BTK Randomized Study to Assess Safety and Efficacy of IN.PACT 014 vs. PTA

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: peripheral arterial disease | Peripheral vascular disease | Critical Limb Ischemia
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Age 18 years.
  2. Subject has been informed of the nature of the study, agrees to participate and has signed an EC approved consent form.
  3. Female subjects of childbearing potential have a negative pregnancy test 7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation;
  4. Subject has documented chronic Critical Limb Ischemia (CLI) in the target limb prior to the study procedure with Rutherford Clinical Category 4 or 5 .
  5. Life expectancy >1 year in the Investigator's opinion.
  6. Reference Vessel Diameter (RVD) 2 - 4 mm, based on visual estimation.
  7. Presence of documented run-off to the foot
  8. Inflow free from flow-limiting lesion confirmed by angiography.
  9. Successful pre-dilatation of the (entire) target lesion.

Exclusion Criteria:

  1. Subject unwilling or unlikely to comply to the appropriate follow-up times for the duration of the study.
  2. Prior stent(s) or bypass surgery within the target vessel(s) (including stents placed within target vessels during the index procedure prior to randomization.
  3. Previous DCB of the target vessel within 6 months prior to index procedure.
  4. Aneurysm in the target vessel.
  5. Angiographic evidence of thrombus within target limb.
  6. Recent MI or stroke < 30 days prior to the index procedure.
  7. Heart failure with Ejection Fraction < 30%.
  8. Impaired renal function (GFR <30 mL/min) and patients on dialysis.
  9. Subject with vasculitis, systemic Lupus Erythematosus or Polymyalgia Rheumatica on active treatment.
  10. Patient receiving systemic corticosteroid therapy.
  11. Known allergies or sensitivities to heparin, aspirin (ASA), other anticoagulant/anti-platelet therapies which could not be substituted, and/or paclitaxel or an allergy to contrast media that cannot be adequately pre-treated prior to the index procedure.
  12. The patient is currently enrolled in another investigational device or drug trial that is interfering with the endpoints of this study.

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

Volunteer Sign-up

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.