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4-EVER : a Trial Investigating the Safety of 4F Endovascular Treatment of Infra-Inguinal Arterial Stenotic Disease — 4-EVER  

Peripheral Vascular Disease Clinical Trial

Official title:
4-EVER Study - Physician-Initiated Trial Investigating the Safety of the Full 4F Endovascular Treatment Approach of Infra-Inguinal Arterial Stenotic Disease

Clinical Trial Summary

The objective of this clinical investigation is to evaluate puncture site complication rate as well as the short- and long-term (up to 24 months) outcome of treatment by means of Astron Pulsar / Astron Pulsar-18 stent implantation in symptomatic (Rutherford 2-4) femoro-popliteal arterial stenotic or occlusive lesions, using 4F compatible devices of BIOTRONIK and without the use of a closure device.

The hypothesis is that the primary patency at 12 months is non-inferior to the primary patency obtained in the Durability study (72.2%).

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01413139
Study type Interventional
Source Flanders Medical Research Program
Contact
Status Completed
Phase Phase 4
Start date July 2010
Completion date September 2013
View Details
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