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:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT00530712
Eligibility Criteria:
Inclusion Criteria:
* Stenotic, restenotic (from PTA or adjunct therapy, not including stents or stent grafts) or occluded lesion(s) located in the native superficial femoral artery or superficial femoral and proximal popliteal arteries.
* Symptomatic femoral-popliteal atherosclerosis.
* Willing to comply with all follow-up evaluations at the specified times.
* Provides written informed consent prior to enrollment in the study.
Exclusion Criteria:
* Previously implanted stent(s) or stent graft(s) in the target vessel.
* Planned use of devices other than angioplasty balloons during procedure.
* Received endovascular treatment of the target lesion (except stents/stent grafts) within six months of the index procedure.
* Life expectancy of less than 12 months.
* Symptomatic femoral disease in the opposite limb.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00530712
Study Brief:
Protocol Section:
NCT00530712