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NCT01094678 Clinical Trial

Zilver® PTX™ Global Registry

Peripheral Arterial Disease Clinical Trial

Official title:
Evaluation of the Safety and Performance of the Zilver® PTX™ Drug-Eluting Stent for Treating De Novo or Restenotic Lesions of the Above-the-knee Femoropopliteal Artery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01094678
Other study ID # 05-518
Secondary ID 100010
Status Completed
Phase N/A
First received March 25, 2010
Last updated September 9, 2014
Start date April 2006
Est. completion date April 2011

Study information
Verified date September 2014
Source Cook
Contact n/a
Is FDA regulated No
Health authority Germany: German Institute of Medical Documentation and InformationKorea: Food and Drug AdministrationItaly: Ministry of HealthCanada: Health CanadaCzech Republic: State Institute for Drug ControlSpain: Agencia Española de Medicamentos y Productos SanitariosFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Switzerland: SwissmedicSweden: Medical Products AgencyPoland: Ministry of HealthNetherlands: Dutch Health Care InspectorateBelgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Study type Interventional

Clinical Trial Summary

The Zilver PTX Registry Study is a prospective, non-randomized, open-label, multicenter single-arm study enrolling patients in Europe, Asia, and North America with de novo or restenotic (including in-stent restenosis) lesions of the above-the-knee femoropopliteal artery (SFA). The primary endpoint of the study is event-free survival (EFS) at 6 months.

Recruitment information / eligibility
Status Completed
Enrollment 788
Est. completion date April 2011
Est. primary completion date January 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- stenosis of the above-the-knee femoropopliteal artery

- appropriate size and location of the lesion

Exclusion Criteria:

- pregnant or breast feeding

- failure or inability to give informed consent

- simultaneously participating in another drug or device study

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Zilver® PTX™ Stent
Stenting of the superfemoropopliteal artery.

Locations
Country Name City State
Germany Heart Center Leipzig, Angiology Leipzig
Germany St. Franziskus Hospital Munster Munster
Germany Universitat Klinik Tubingen Tubingen
Italy University of Roma La Sapienza Rome

Sponsors (1)
Lead Sponsor Collaborator
Cook

Countries where clinical trial is conducted

Germany,  Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Event-free Survival 6 months Yes
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