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 @ 4:31 PM
Ignite Modification Date:
2025-12-24 @ 4:31 PM
NCT ID:
NCT02237066
Eligibility Criteria:
Inclusion Criteria:
* Reference Vessel Diameter (RVD) between 2.5 and 6.0mm and within treatment range of available balloon at Target Lesion
* Intermittent claudication or critical limb ischemia (Rutherford 3-5)
* De novo stenosis (≥70%) or occlusion in the infrainguinal arteries, including superficial femoral artery (SFA), popliteal, and infrapopliteal arteries.
* Lesion successfully crossed with a guide-wire
* Patient has given informed consent to participate in this study
Exclusion Criteria:
* Lesion requiring ablative procedures (i.e. atherectomy or laser) as part of treatment
* Lesion length \>75mm
* Previous bypass or stent at target vessel or proximal to target vessel
* Significant in-flow disease at target lesion
* Known inadequate distal outflow disease or planned treatment of vessel distal to target lesion
* Acute limb ischemia or need for thrombolytic therapy
* Known intolerance to required study medications, contrast media, or nitinol
* Known impaired Renal Function with Glomerular Filtration Rate (GFR) \<45 ml/min per 1.73m2
* Known bleeding disorder or uncontrolled hypercoagulable disorder.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02237066
Study Brief:
Protocol Section:
NCT02237066