Clinical trial NCT01901289: Zilver® PTX® V Clinical Study
Official title: Zilver® PTX® Drug-Eluting Peripheral Stent Post-Approval Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Peripheral Vascular Disease
Femoral Artery
Popliteal Artery
Drug-Eluting Stent
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2013-07-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Patients Without Target Lesion Revascularization (TLR)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
city: Stanford
country: United States
facility: Stanford University Medical School
state: California
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Gainesville
country: United States
facility: The Cardiac and Vascular Institute
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: First Coast Cardiovascular Institute
state: Florida
city: Elk Grove Village
country: United States
facility: Alexian Brothers Medical Center
state: Illinois
city: Baltimore
country: United States
facility: Bayview Medical Center
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: New York-Presbyterian/ Weill Cornell Medical Center
state: New York
city: Columbus
country: United States
facility: OhioHealth Research Institute
state: Ohio
city: Toledo
country: United States
facility: University of Toledo Medical Center
state: Ohio
city: Camp Hill
country: United States
facility: Holy Spirit Hospital
state: Pennsylvania
city: Columbia
country: United States
facility: South Carolina Heart Center
state: South Carolina
city: Greenville
country: United States
facility: Greenville Hospital System
state: South Carolina
city: Kingsport
country: United States
facility: Holston Valley Hospital
state: Tennessee
Study officials:
References:
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.