Zilver® PTX™ Global Registry

Not Applicable

Completed

• Conditions: Peripheral Arterial Disease; Peripheral Vascular Disease
• Interventions: Device: Zilver® PTX™ Stent

• Registration Number: NCT01094678
• Lead Sponsor: Cook Group Incorporated

Brief Summary

The Zilver PTX Registry Study is a prospective, non-randomized, open-label, multicenter single-arm study enrolling patients in Europe, Asia, and North America with de novo or restenotic (including in-stent restenosis) lesions of the above-the-knee femoropopliteal artery (SFA). The primary endpoint of the study is event-free survival (EFS) at 6 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Primary Completion: 2009-01
• Study First Submitted: 2010-03-25
• Study First Submitted QC: 2010-03-26
• Study First Posted: 2010-03-29
• Study Completion: 2011-04
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-09
• Last Update Posted: 2014-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 788

Inclusion Criteria

• stenosis of the above-the-knee femoropopliteal artery
• appropriate size and location of the lesion

Exclusion Criteria

• pregnant or breast feeding
• failure or inability to give informed consent
• simultaneously participating in another drug or device study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stent	Zilver® PTX™ Stent	-

Primary Outcome Measures

Name	Time	Method
Event-free Survival	6 months

Trial Locations

Locations (4)

University of Roma La Sapienza; 🇮🇹 Rome, Italy

St. Franziskus Hospital Munster; 🇩🇪 Munster, Germany

Universitat Klinik Tubingen; 🇩🇪 Tubingen, Germany

Heart Center Leipzig, Angiology; 🇩🇪 Leipzig, Germany