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:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT01537302
Eligibility Criteria:
Inclusion Criteria:
* Patient is willing and able to provide informed consent
* Patient is willing and able to comply with the study protocol
* Patient is \> 18 years old
* Patient has peripheral arterial disease requiring revascularization as evidenced by CTA, MRA or angiography
* Patient has an occluded femoropopliteal artery that is 99-100% stenosed and is ≥ 1 cm and ≤ 30 cm in length by visual estimate
* Target vessel is ≥ 3.0 mm in diameter
* Patient has Rutherford Classification of 2-5
* Lesion is recalcitrant to guidewire crossing
Exclusion Criteria:
* Patient has a known sensitivity or allergy to contrast materials that cannot be adequately pre-treated
* Patient has a known sensitivity or allergy to aspirin, heparin or anti-platelet medications
* Patient is pregnant or lactating
* Patient has a co-existing disease or medical condition contraindicating percutaneous intervention
* Target vessel is severely calcified as evidenced by angiography
* Target lesion is in a bypass graft
* Target lesion is in a stent (i.e., in-stent restenosis)
* Patient has had a procedure on the target limb within 7 days
* Patient has had a procedure on the target limb within the past 30 days and is unstable
* Patient has a planned surgical or interventional procedure within 30 days after the study procedure
* Patient is simultaneously participating in an investigational device study for treatment of peripheral vascular disease
* Patient has a planned amputation of the target limb
* Patient has a history of bleeding diathesis, coagulopathy or will refuse blood transfusion in cases of emergency
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01537302
Study Brief:
Protocol Section:
NCT01537302