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

NCT ID: NCT02936622

Last Updated: 2024-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 176 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-21
• Study Completion Date: 2023-10-25

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.

Conditions

Peripheral Arterial Disease (PAD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Stent 1

Zilver® PTX Stent

Group Type: EXPERIMENTAL

Zilver® Paclitaxel-Eluting Peripheral Stent

Intervention Type: DEVICE

Paclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent.

Stent 2

Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coating

Group Type: EXPERIMENTAL

Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coating

Intervention Type: DEVICE

Paclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent.

Stent 3

Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coating

Group Type: EXPERIMENTAL

Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coating

Intervention Type: DEVICE

Paclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent.

Interventions

Zilver® Paclitaxel-Eluting Peripheral Stent

Paclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent.

Intervention Type: DEVICE

Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coating

Paclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent.

Intervention Type: DEVICE

Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coating

Paclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cook Group Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Zeller, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Universitäts Herzzentrum Freiburg - Bad Krozingen

Locations

Klinikum Hochsauerland

Arnsberg, , Germany

Universitäts Herzzentrum Freiburg - Bad Krozingen

Bad Krozingen, , Germany

Krankenhaud Bucholz

Buchholz, , Germany

St. Josefskrankenhaus Heidelberg

Heidelberg, , Germany

Universitätsklinikum Jena

Jena, , Germany

SRH Klinikum Karlsbad- Langensteinbach GmbH

Karlsruhe, , Germany

Universitatsklinikum Leipzig AoR

Leipzig, , Germany

MEDINOS Kliniken des Landkreises Sonneberg GmbH

Sonneberg, , Germany

Marienhospital Stuttgart

Stuttgart, , Germany

Uniklinikum Würzburg

Würzburg, , Germany

Auckland City Hospital, New Zealand

Auckland, , New Zealand

Countries

Germany; New Zealand

Other Identifiers

13-002

Identifier Type: -

Identifier Source: org_study_id