Paclitaxel-coated Peripheral Stents Used in the Treatment of Femoropopliteal Stenoses
NCT02936622 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 176
Last updated 2024-04-05
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)
Interventions
- DEVICE
-
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.
- 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.
- 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.
Sponsors & Collaborators
-
Cook Group Incorporated
lead INDUSTRY
Principal Investigators
-
Thomas Zeller, Prof. Dr. med. · Universitäts Herzzentrum Freiburg - Bad Krozingen
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-02-21
- Primary Completion
- 2019-04-23
- Completion
- 2023-10-25
Countries
- Germany
- New Zealand
Study Locations
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