Zilver® PTX® V Clinical Study
- Conditions
- Peripheral Arterial Disease
- Interventions
- Device: Zilver® PTX® Drug-Eluting Peripheral Stent
- Registration Number
- NCT01901289
- Lead Sponsor
- Cook Research Incorporated
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Drug-Eluting Stent Zilver® PTX® Drug-Eluting Peripheral Stent -
- Primary Outcome Measures
Name Time Method Patients Without Target Lesion Revascularization (TLR) 1 year 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
Name Time Method
Trial Locations
- Locations (17)
The Cardiac and Vascular Institute
🇺🇸Gainesville, Florida, United States
First Coast Cardiovascular Institute
🇺🇸Jacksonville, Florida, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Alexian Brothers Medical Center
🇺🇸Elk Grove Village, Illinois, United States
VA Palo Alto Health Care System
🇺🇸Palo Alto, California, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
New York-Presbyterian/ Weill Cornell Medical Center
🇺🇸New York, New York, United States
Greenville Hospital System
🇺🇸Greenville, South Carolina, United States
University of Toledo Medical Center
🇺🇸Toledo, Ohio, United States
Bayview Medical Center
🇺🇸Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
OhioHealth Research Institute
🇺🇸Columbus, Ohio, United States
Holston Valley Hospital
🇺🇸Kingsport, Tennessee, United States
South Carolina Heart Center
🇺🇸Columbia, South Carolina, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Stanford University Medical School
🇺🇸Stanford, California, United States
Holy Spirit Hospital
🇺🇸Camp Hill, Pennsylvania, United States