Paclitaxel-coated Peripheral Stents Used in the Treatment of Femoropopliteal Stenoses

Not Applicable

Completed

• Conditions: Peripheral Arterial Disease (PAD)
• Interventions: Device: Zilver® Paclitaxel-Eluting Peripheral Stent; Device: Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coating; Device: Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coating

• Registration Number: NCT02936622
• Lead Sponsor: Cook Group Incorporated

Brief Summary

This randomized multi-center study is intended to compare different coatings on stents for treatment of lesions of the above-the-knee femoropopliteal artery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-12
• Study First Submitted QC: 2016-10-14
• Study First Posted: 2016-10-18
• Study Start: 2017-02-21
• Primary Completion: 2019-04-23
• Study Completion: 2023-10-25
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-04
• Last Update Posted: 2024-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

• One de novo or restenosed artherosclerotic lesion with ≥ 50% diameter stenosis
• Symptoms of peripheral arterial disease (Rutherford 2-4)

Exclusion Criteria

• Pregnant, breastfeeding, or planning to become pregnant in the next 5 years
• Less than 18 years old
• Medical condition or disorder that would limit life expectancy to less than 12 months or that may cause noncompliance with the protocol or confound the data analysis
• Previous stent in the study vessel

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stent 1	Zilver® Paclitaxel-Eluting Peripheral Stent	Zilver® PTX Stent
Stent 3	Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coating	Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coating
Stent 2	Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coating	Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coating

Primary Outcome Measures

Name	Time	Method
The percent diameter stenosis within the study lesion evaluated by conventional angiography.	6 months	Percent diameter stenosis will be calculated by comparing the minimal lumen diameter to the average of the proximal and distal reference vessel diameters.

Trial Locations

Locations (11)

Klinikum Hochsauerland; 🇩🇪 Arnsberg, Germany

Krankenhaud Bucholz; 🇩🇪 Buchholz, Germany

Universitätsklinikum Jena; 🇩🇪 Jena, Germany

SRH Klinikum Karlsbad- Langensteinbach GmbH; 🇩🇪 Karlsruhe, Germany

St. Josefskrankenhaus Heidelberg; 🇩🇪 Heidelberg, Germany

Universitatsklinikum Leipzig AoR; 🇩🇪 Leipzig, Germany

Marienhospital Stuttgart; 🇩🇪 Stuttgart, Germany

Uniklinikum Würzburg; 🇩🇪 Würzburg, Germany

Universitäts Herzzentrum Freiburg - Bad Krozingen; 🇩🇪 Bad Krozingen, Germany

MEDINOS Kliniken des Landkreises Sonneberg GmbH; 🇩🇪 Sonneberg, Germany

Auckland City Hospital, New Zealand; 🇳🇿 Auckland, New Zealand