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

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

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 176
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Arnsberg, Germany, 59759
    • Klinikum Hochsauerland
  • Bad Krozingen, Germany, 79189
    • Universitäts Herzzentrum Freiburg - Bad Krozingen
  • Buchholz, Germany, 21244
    • Krankenhaud Bucholz
  • Heidelberg, Germany, 69115
    • St. Josefskrankenhaus Heidelberg
  • Jena, Germany, 07747
    • Universitätsklinikum Jena
  • Karlsruhe, Germany, 76307
    • SRH Klinikum Karlsbad- Langensteinbach GmbH
  • Leipzig, Germany, 04103
    • Universitätsklinikum Leipzig AöR
  • Sonneberg, Germany, 96515
    • MEDINOS Kliniken des Landkreises Sonneberg GmbH
  • Stuttgart, Germany, 70199
    • Marienhospital Stuttgart
  • Würzburg, Germany, 70199
    • Uniklinikum Wurzburg
• New Zealand
  • Auckland, New Zealand, 1023
    • Auckland City Hospital, New Zealand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stent 1; Zilver® PTX Stent	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.
Experimental: Stent 2; Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coating	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.
Experimental: Stent 3; Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coating	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cook Group Incorporated
• Investigators: Principal Investigator: Thomas Zeller, Prof. Dr. med., Universitäts Herzzentrum Freiburg - Bad Krozingen

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2017
• Primary Completion (Actual): April 23, 2019
• Study Completion (Actual): October 25, 2023

Study Registration Dates

• First Submitted: October 12, 2016
• First Submitted That Met QC Criteria: October 14, 2016
• First Posted (Estimated): October 18, 2016

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Albumin-Bound Paclitaxel
• Other Study ID Numbers: 13-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes