Zilver® PTX® V Clinical Study

Zilver® PTX® Drug-Eluting Peripheral Stent Post-Approval Study

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: Zilver® PTX® Drug-Eluting Peripheral Stent

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • VA Palo Alto Health Care System
    • Stanford, California, United States, 94305
      • Stanford University Medical School
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital Center
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida
    • Gainesville, Florida, United States, 32605
      • The Cardiac and Vascular Institute
    • Jacksonville, Florida, United States, 32216
      • First Coast Cardiovascular Institute
  • Illinois
    • Elk Grove Village, Illinois, United States, 60007
      • Alexian Brothers Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Bayview Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10065
      • New York-Presbyterian/ Weill Cornell Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43214
      • OhioHealth Research Institute
    • Toledo, Ohio, United States, 43614
      • University of Toledo Medical Center
  • Pennsylvania
    • Camp Hill, Pennsylvania, United States, 17011
      • Holy Spirit Hospital
  • South Carolina
    • Columbia, South Carolina, United States, 29204
      • South Carolina Heart Center
    • Greenville, South Carolina, United States, 29615
      • Greenville Hospital System
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Holston Valley Hospital

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drug-Eluting Stent	Device: Zilver® PTX® Drug-Eluting Peripheral Stent; Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Collaborators and Investigators

• Sponsor: Cook Research Incorporated

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): November 18, 2016
• Study Completion (Actual): February 15, 2021

Study Registration Dates

• First Submitted: July 8, 2013
• First Submitted That Met QC Criteria: July 15, 2013
• First Posted (Estimate): July 17, 2013

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 9, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Peripheral Vascular Disease; Drug-Eluting Stent; Femoral Artery; Popliteal Artery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 12-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No