Zilver® PTX® V Clinical Study
Zilver® PTX® Drug-Eluting Peripheral Stent Post-Approval Study
1 other identifier
interventional
200
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2013
Longer than P75 for not_applicable
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2013
CompletedFirst Posted
Study publicly available on registry
July 17, 2013
CompletedStudy Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 18, 2016
CompletedResults Posted
Study results publicly available
July 3, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2021
CompletedMarch 2, 2022
February 1, 2022
3.3 years
July 8, 2013
June 6, 2018
February 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Drug-Eluting Stent
EXPERIMENTALInterventions
Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
VA Palo Alto Health Care System
Palo Alto, California, 94304, United States
Stanford University Medical School
Stanford, California, 94305, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
The Cardiac and Vascular Institute
Gainesville, Florida, 32605, United States
University of Florida
Gainesville, Florida, 32610, United States
First Coast Cardiovascular Institute
Jacksonville, Florida, 32216, United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, 60007, United States
Bayview Medical Center
Baltimore, Maryland, 21224, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Columbia University Medical Center
New York, New York, 10032, United States
New York-Presbyterian/ Weill Cornell Medical Center
New York, New York, 10065, United States
OhioHealth Research Institute
Columbus, Ohio, 43214, United States
University of Toledo Medical Center
Toledo, Ohio, 43614, United States
Holy Spirit Hospital
Camp Hill, Pennsylvania, 17011, United States
South Carolina Heart Center
Columbia, South Carolina, 29204, United States
Greenville Hospital System
Greenville, South Carolina, 29615, United States
Holston Valley Hospital
Kingsport, Tennessee, 37660, United States
Related Publications (1)
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.
PMID: 33025243DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Manager, Biostatistics
- Organization
- Cook Research Incorporated
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2013
First Posted
July 17, 2013
Study Start
August 1, 2013
Primary Completion
November 18, 2016
Study Completion
February 15, 2021
Last Updated
March 2, 2022
Results First Posted
July 3, 2018
Record last verified: 2022-02