Zilver® PTX™ Global Registry

Cook Group Incorporated788 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

788

Conditions

Peripheral Arterial Disease Peripheral Vascular Disease

Interventions

Zilver® PTX™ StentDEVICE

Stenting of the superfemoropopliteal artery.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Heart Center Leipzig, Angiology

Leipzig, Germany

St. Franziskus Hospital Munster

Münster, Germany

Universitat Klinik Tubingen

Tübingen, Germany

University of Roma La Sapienza

Rome, Italy

Outcomes

Primary Outcomes

Event-free Survival

Time frame: 6 months

Data from ClinicalTrials.gov

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