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NCT02936622 Clinical Trial

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

Peripheral Arterial Disease (PAD) Clinical Trial

— XPEDITE  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02936622
Other study ID # 13-002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 21, 2017
Est. completion date October 25, 2023

Study information
Verified date April 2024
Source Cook Group Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 176
Est. completion date October 25, 2023
Est. primary completion date April 23, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.
• 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.
• 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.

Locations
Country Name City State
Germany 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
New Zealand Auckland City Hospital, New Zealand Auckland

Sponsors (1)
Lead Sponsor Collaborator
Cook Group Incorporated

Countries where clinical trial is conducted

Germany,  New Zealand, 

Outcome
Type Measure Description Time frame Safety issue
Primary The percent diameter stenosis within the study lesion evaluated by conventional angiography. Percent diameter stenosis will be calculated by comparing the minimal lumen diameter to the average of the proximal and distal reference vessel diameters. 6 months
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