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Zilver PTX Delivery System

Primary Purpose

Peripheral Vascular Disease

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Zilver® PTX® Drug-Eluting Peripheral Stent
Sponsored by
Cook Group Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Vascular Disease focused on measuring Peripheral Vascular Disease, Femoral Artery, Drug-Eluting Stent

Eligibility Criteria

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

Inclusion Criteria:

  • Patient has symptomatic vascular disease of the native above-the-knee femoropopliteal arteries
  • Patient has atherosclerotic lesion of the above-the-knee femoropopliteal artery

Exclusion Criteria:

  • Patient is < 18 years of age
  • Patient unable to complete required follow-up assessments
  • Patient unwilling to sign and date the informed consent
  • Simultaneous participation in another investigational drug or device study
  • Pregnant, breastfeeding or planning to become pregnant in the next 5 years
  • Additional medical/anatomical restrictions as specified in the Clinical Investigation Plan

Sites / Locations

  • Frankston Hospital
  • Princess Alexandra Hospital
  • Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH
  • Auckland City Hospital
  • Waikato Hospital
  • Wellington Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Drug Eluting Stent

Arm Description

Zilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent

Outcomes

Primary Outcome Measures

Mean Percent Change in Stent Length Upon Deployment

Secondary Outcome Measures

Full Information

First Posted
October 17, 2014
Last Updated
January 29, 2016
Sponsor
Cook Group Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT02271529
Brief Title
Zilver PTX Delivery System
Official Title
Zilver Paclitaxel(PTX) Thumbwheel Delivery System
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to evaluate the performance of the Zilver PTX stent thumbwheel delivery system.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Vascular Disease
Keywords
Peripheral Vascular Disease, Femoral Artery, Drug-Eluting Stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug Eluting Stent
Arm Type
Experimental
Arm Description
Zilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent
Intervention Type
Device
Intervention Name(s)
Zilver® PTX® Drug-Eluting Peripheral Stent
Intervention Description
Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
Primary Outcome Measure Information:
Title
Mean Percent Change in Stent Length Upon Deployment
Time Frame
Immediately following completion of the stent placement procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient has symptomatic vascular disease of the native above-the-knee femoropopliteal arteries Patient has atherosclerotic lesion of the above-the-knee femoropopliteal artery Exclusion Criteria: Patient is < 18 years of age Patient unable to complete required follow-up assessments Patient unwilling to sign and date the informed consent Simultaneous participation in another investigational drug or device study Pregnant, breastfeeding or planning to become pregnant in the next 5 years Additional medical/anatomical restrictions as specified in the Clinical Investigation Plan
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Holden, MD
Organizational Affiliation
Auckland District Health Board
Official's Role
Principal Investigator
Facility Information:
Facility Name
Frankston Hospital
City
Frankston
ZIP/Postal Code
Vic 3199
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
ZIP/Postal Code
Qld 4102
Country
Australia
Facility Name
Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH
City
Bad Krozingen
ZIP/Postal Code
D-79189
Country
Germany
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
ZIP/Postal Code
3248
Country
New Zealand
Facility Name
Wellington Hospital
City
Wellington
ZIP/Postal Code
3248
Country
New Zealand

12. IPD Sharing Statement

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Zilver PTX Delivery System

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