NCT01413139

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Flanders Medical Research Program · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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%).

Conditions

• Peripheral Vascular Disease
• Claudication

Interventions

Type	Name	Description
DEVICE	4F portfolio products from Biotronik	4F portfolio products from Biotronik: Astron pulsar / Astron Pulsar-18, Fortress, Passeo-18, Cruiser-18

Timeline

• Start date: 2010-07-01
• Primary completion: 2011-05-01
• Completion: 2013-09-01
• First posted: 2011-08-10
• Last updated: 2013-10-01

Locations

5 sites across 2 countries: Belgium, Germany