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Zilver PTX Drug-Eluting Peripheral Stent Study

Primary Purpose

Peripheral Arterial Disease

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Longer Zilver PTX Stents
Shorter Zilver PTX Stents
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 focused on measuring 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
  • Reference vessel diameter of 4 - 9 mm
  • Rutherford category ≥ 2
  • Resting ankle brachial index < 0.9

Exclusion Criteria:

  • Prior stent in the study vessel
  • Significant stenosis (> 50%) or occlusion of inflow tract not successfully treated before the study procedure
  • Lacks at least one patent runoff vessel
  • Lesions requiring atherectomy, cutting balloons, cryoplasty balloons, or any other advanced device to facilitate stent delivery

Sites / Locations

  • Herz-Zentrum
  • Evangelische Krankenhaus Königin Elisabeth Herzberge
  • Universitätsklinikum Magdeburg A.ö.R.
  • INSELSPITAL, Universitätsspital Bern

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Longer Stents

Shorter Stents

Arm Description

Outcomes

Primary Outcome Measures

Percent Change in Stent Length Upon Deployment

Secondary Outcome Measures

Full Information

First Posted
April 29, 2011
Last Updated
December 29, 2015
Sponsor
Cook Group Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01348425
Brief Title
Zilver PTX Drug-Eluting Peripheral Stent Study
Official Title
Evaluation of the Zilver PTX Drug-Eluting Peripheral Stent
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
This randomized, post-market clinical study is intended to evaluate the delivery and deployment of longer Zilver PTX stents (≥ 100 mm) compared to shorter Zilver PTX stents (≤80 mm) 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
Keywords
PAD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Longer Stents
Arm Type
Experimental
Arm Title
Shorter Stents
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Longer Zilver PTX Stents
Intervention Description
Treatment with at least one 100 mm or longer Zilver PTX stent
Intervention Type
Device
Intervention Name(s)
Shorter Zilver PTX Stents
Intervention Description
Treatment with Zilver PTX stents 80 mm or shorter only
Primary Outcome Measure Information:
Title
Percent Change in Stent Length Upon Deployment
Time Frame
During Procedure (day 1) (Prior to Stent Deployment and after Stent Deployment)

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 Reference vessel diameter of 4 - 9 mm Rutherford category ≥ 2 Resting ankle brachial index < 0.9 Exclusion Criteria: Prior stent in the study vessel Significant stenosis (> 50%) or occlusion of inflow tract not successfully treated before the study procedure Lacks at least one patent runoff vessel Lesions requiring atherectomy, cutting balloons, cryoplasty balloons, or any other advanced device to facilitate stent delivery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Dr. med. Jens Ricke
Organizational Affiliation
Universitätsklinikum Magdeburg A.ö.R., Department for Radiology and Nuclear Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herz-Zentrum
City
Bad Krozingen
ZIP/Postal Code
79189
Country
Germany
Facility Name
Evangelische Krankenhaus Königin Elisabeth Herzberge
City
Berlin
ZIP/Postal Code
10365
Country
Germany
Facility Name
Universitätsklinikum Magdeburg A.ö.R.
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
INSELSPITAL, Universitätsspital Bern
City
Berne
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

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Zilver PTX Drug-Eluting Peripheral Stent Study

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