Safety and Effectiveness Study of EverFlex Stent to Treat Symptomatic Femoral-popliteal Atherosclerosis (DURABILITY II)

Medtronic

Status: Completed

Conditions: Claudication; Peripheral Vascular Diseases

Treatments: Device: PROTÉGÉ® EverFlex™ Self-Expanding Stent System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00530712

P-2424

Details and patient eligibility

About

This is a multi-center, non-randomized, single arm study to compare PTA and primary stenting using a single PROTÉGÉ® EverFlex™ stent to performance goals of PTA alone in the treatment of atherosclerotic superficial femoral artery (SFA) and proximal popliteal lesions.

Enrollment: 287 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

287 participants in 1 patient group

PTA and Stenting with EverFlex device

Experimental group

Description:

Qualified subjects undergo treatment of atherosclerotic lesions in the native SFA/SFA/PPA with PTA and stenting using the PROTÉGÉ® EverFlex™ Self-Expanding Stent System

Treatment:

Device: PROTÉGÉ® EverFlex™ Self-Expanding Stent System