search
Back to results

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

Primary Purpose

Peripheral Arterial Disease (PAD)

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Zilver® Paclitaxel-Eluting Peripheral Stent
Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coating
Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coating
Sponsored by
Cook Group Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease (PAD)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Klinikum Hochsauerland
  • Universitäts Herzzentrum Freiburg - Bad Krozingen
  • Krankenhaud Bucholz
  • St. Josefskrankenhaus Heidelberg
  • Universitätsklinikum Jena
  • SRH Klinikum Karlsbad- Langensteinbach GmbH
  • Universitatsklinikum Leipzig AoR
  • MEDINOS Kliniken des Landkreises Sonneberg GmbH
  • Marienhospital Stuttgart
  • Uniklinikum Würzburg
  • Auckland City Hospital, New Zealand

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Stent 1

Stent 2

Stent 3

Arm Description

Zilver® PTX Stent

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 12, 2016
Last Updated
July 31, 2023
Sponsor
Cook Group Incorporated
search

1. Study Identification

Unique Protocol Identification Number
NCT02936622
Brief Title
Paclitaxel-coated Peripheral Stents Used in the Treatment of Femoropopliteal Stenoses
Acronym
XPEDITE
Official Title
Paclitaxel-coated Peripheral Stents Used in the Treatment of Femoropopliteal Stenoses
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 21, 2017 (Actual)
Primary Completion Date
April 23, 2019 (Actual)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cook Group Incorporated

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease (PAD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
176 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stent 1
Arm Type
Experimental
Arm Description
Zilver® PTX Stent
Arm Title
Stent 2
Arm Type
Experimental
Arm Description
Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coating
Arm Title
Stent 3
Arm Type
Experimental
Arm Description
Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coating
Intervention Type
Device
Intervention Name(s)
Zilver® Paclitaxel-Eluting Peripheral Stent
Intervention Description
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
Intervention Name(s)
Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coating
Intervention Description
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
Intervention Name(s)
Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coating
Intervention Description
Paclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent.
Primary Outcome Measure Information:
Title
The percent diameter stenosis within the study lesion evaluated by conventional angiography.
Description
Percent diameter stenosis will be calculated by comparing the minimal lumen diameter to the average of the proximal and distal reference vessel diameters.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Zeller, Prof. Dr. med.
Organizational Affiliation
Universitäts Herzzentrum Freiburg - Bad Krozingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum Hochsauerland
City
Arnsberg
ZIP/Postal Code
59759
Country
Germany
Facility Name
Universitäts Herzzentrum Freiburg - Bad Krozingen
City
Bad Krozingen
ZIP/Postal Code
79189
Country
Germany
Facility Name
Krankenhaud Bucholz
City
Buchholz
ZIP/Postal Code
21244
Country
Germany
Facility Name
St. Josefskrankenhaus Heidelberg
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
Facility Name
Universitätsklinikum Jena
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
SRH Klinikum Karlsbad- Langensteinbach GmbH
City
Karlsruhe
ZIP/Postal Code
76307
Country
Germany
Facility Name
Universitatsklinikum Leipzig AoR
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
MEDINOS Kliniken des Landkreises Sonneberg GmbH
City
Sonneberg
ZIP/Postal Code
96515
Country
Germany
Facility Name
Marienhospital Stuttgart
City
Stuttgart
ZIP/Postal Code
70199
Country
Germany
Facility Name
Uniklinikum Würzburg
City
Würzburg
ZIP/Postal Code
70199
Country
Germany
Facility Name
Auckland City Hospital, New Zealand
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs