Zilver® PTX® V Clinical Study

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01901289
• Other study ID #: 12-004
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Est. completion date: February 15, 2021

Study information

• Verified date: February 2022
• Source: Cook Group Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 15, 2021
• Est. primary completion date: November 18, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• Zilver® PTX® Drug-Eluting Peripheral Stent
Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.

Locations

Country	Name	City	State
United States	Bayview Medical Center	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Holy Spirit Hospital	Camp Hill	Pennsylvania
United States	South Carolina Heart Center	Columbia	South Carolina
United States	OhioHealth Research Institute	Columbus	Ohio
United States	Alexian Brothers Medical Center	Elk Grove Village	Illinois
United States	The Cardiac and Vascular Institute	Gainesville	Florida
United States	University of Florida	Gainesville	Florida
United States	Greenville Hospital System	Greenville	South Carolina
United States	First Coast Cardiovascular Institute	Jacksonville	Florida
United States	Holston Valley Hospital	Kingsport	Tennessee
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	VA Palo Alto Health Care System	Palo Alto	California
United States	Stanford University Medical School	Stanford	California
United States	University of Toledo Medical Center	Toledo	Ohio
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Cook Research Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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