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Zilver® PTX® V Clinical Study

Primary Purpose

Peripheral Arterial Disease

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

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  • Patient has signed and dated the informed consent.
  • Patient has symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
  • Patient agrees to return for the required follow-up assessments.

Exclusion Criteria:

  • Patient is < 18 years of age.
  • Patient has significant stenosis of inflow tract not successfully treated before this procedure.
  • Patient lacks at least one patent vessel of runoff with < 50% stenosis throughout its course.

Sites / Locations

  • VA Palo Alto Health Care System
  • Stanford University Medical School
  • Washington Hospital Center
  • The Cardiac and Vascular Institute
  • University of Florida
  • First Coast Cardiovascular Institute
  • Alexian Brothers Medical Center
  • Bayview Medical Center
  • Beth Israel Deaconess Medical Center
  • Columbia University Medical Center
  • New York-Presbyterian/ Weill Cornell Medical Center
  • OhioHealth Research Institute
  • University of Toledo Medical Center
  • Holy Spirit Hospital
  • South Carolina Heart Center
  • Greenville Hospital System
  • Holston Valley Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Drug-Eluting Stent

Arm Description

Outcomes

Primary Outcome Measures

Patients Without Target Lesion Revascularization (TLR)
A reintervention performed for ≥ 50 % diameter stenosis within ± 5 mm proximal and /or distal to the target lesion after documentation of recurrent clinical symptoms of peripheral arterial disease (PAD) following the initial procedure.

Secondary Outcome Measures

Full Information

First Posted
July 8, 2013
Last Updated
February 9, 2022
Sponsor
Cook Research Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01901289
Brief Title
Zilver® PTX® V Clinical Study
Official Title
Zilver® PTX® Drug-Eluting Peripheral Stent Post-Approval Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
November 18, 2016 (Actual)
Study Completion Date
February 15, 2021 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No

5. Study Description

Brief Summary
The Zilver® PTX® V Clinical Study is a post-market clinical trial required by the US FDA to provide continued evaluation of the safety and effectiveness of the Zilver PTX Drug-Eluting Peripheral Stent in treatment of narrowing of the femoropopliteal arteries.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
Peripheral Vascular Disease, Femoral Artery, Popliteal 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
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug-Eluting Stent
Arm Type
Experimental
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
Patients Without Target Lesion Revascularization (TLR)
Description
A reintervention performed for ≥ 50 % diameter stenosis within ± 5 mm proximal and /or distal to the target lesion after documentation of recurrent clinical symptoms of peripheral arterial disease (PAD) following the initial procedure.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient has signed and dated the informed consent. Patient has symptomatic vascular disease of the native above-the-knee femoropopliteal arteries. Patient agrees to return for the required follow-up assessments. Exclusion Criteria: Patient is < 18 years of age. Patient has significant stenosis of inflow tract not successfully treated before this procedure. Patient lacks at least one patent vessel of runoff with < 50% stenosis throughout its course.
Facility Information:
Facility Name
VA Palo Alto Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Stanford University Medical School
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
The Cardiac and Vascular Institute
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
First Coast Cardiovascular Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Alexian Brothers Medical Center
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
New York-Presbyterian/ Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
OhioHealth Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
University of Toledo Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Holy Spirit Hospital
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
South Carolina Heart Center
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
Greenville Hospital System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Holston Valley Hospital
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request after final report has been distributed and ending 5 years after final report has been distributed. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.
Citations:
PubMed Identifier
33025243
Citation
Dake MD, Fanelli F, Lottes AE, O'Leary EE, Reichert H, Jiang X, Fu W, Iida O, Zen K, Schermerhorn M, Zeller T, Ansel GM. Prediction Model for Freedom from TLR from a Multi-study Analysis of Long-Term Results with the Zilver PTX Drug-Eluting Peripheral Stent. Cardiovasc Intervent Radiol. 2021 Feb;44(2):196-206. doi: 10.1007/s00270-020-02648-6. Epub 2020 Oct 6.
Results Reference
derived

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Zilver® PTX® V Clinical Study

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