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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Arterial Disease (PAD)
• Peripheral Vascular Diseases

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