Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-24 @ 7:36 PM
NCT ID:
NCT02044003
Eligibility Criteria:
Inclusion Criteria:
* Age \>18 and \< 85 years
* Patient or patient's legal representative have been informed of the nature of the study, agrees to participate and has signed the approved consent form.
* Patient has documented chronic limb ischemia with Rutherford Category 2, 3, 4, or 5. Clinical conditions of claudication or rest pain or ischemic ulceration or minor gangrene as diagnosed by the investigator
* Reference vessel diameter between 2 and 7mm
* Target lesion is not severely calcified
* At least one patent tibial runoff vessel is present.
* Patient has patent iliac or femoral arteries that allow endovascular access to the site with the Introducer Sheath or Delivery Catheter or these can be treated at the time of the procedure and achieve a \<30% residual stenosis at each inflow lesion.
* Ability to pass the guidewire across the atherosclerotic lesion.
* No evidence of aneurysm or acute thrombus in target vessel.
Exclusion Criteria:
* Severe or infected gangrene of the lower extremity
* Planned major amputation
* Previously implanted stent at the treatment site
* Patient is morbidly obese or has other clinical conditions that severely inhibit X-ray visualization.
* Patient has connective tissue disease (e.g., Marfan's syndrome).
* Inability to tolerate antiplatelet agents
* Patient is hypercoagulable
* Patient has allergy to vascular contrast for which they cannot be premedicated.
* Patient is in acute renal failure or chronic renal insufficiency or failure as measured by a serum creatinine of \>2.2 mg/dL.
* Patient has active systemic infection
* Patient has a less than one year life expectancy.
* Patient is pregnant or nursing.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT02044003
Study Brief:
Protocol Section:
NCT02044003