Zilver PTX Drug-Eluting Peripheral Stent Study

Cook Group

Status: Completed

Conditions: Peripheral Arterial Disease

Treatments: Device: Shorter Zilver PTX Stents; Device: Longer Zilver PTX Stents

Study type: Interventional

Funder types: Industry

Identifiers

NCT01348425

11-003

Details and patient eligibility

About

This randomized, post-market clinical study is intended to evaluate the delivery and deployment of longer Zilver PTX stents (≥ 100 mm) compared to shorter Zilver PTX stents (≤80 mm) for treatment of lesions of the above-the-knee femoropopliteal artery.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• One de novo or restenosed artherosclerotic lesion with > 50% diameter stenosis
• Reference vessel diameter of 4 - 9 mm
• Rutherford category ≥ 2
• Resting ankle brachial index < 0.9

Exclusion criteria

• Prior stent in the study vessel
• Significant stenosis (> 50%) or occlusion of inflow tract not successfully treated before the study procedure
• Lacks at least one patent runoff vessel
• Lesions requiring atherectomy, cutting balloons, cryoplasty balloons, or any other advanced device to facilitate stent delivery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Longer Stents

Experimental group

Treatment:

Device: Longer Zilver PTX Stents

Shorter Stents

Experimental group

Treatment:

Device: Shorter Zilver PTX Stents