NCT01336101

Evaluation of Efficacy of the EPIC™ Self-Expanding Nitinol Vascular Stent

Evaluation of Efficacy of the EPIC™ Self-Expanding Nitinol Vascular Stent With Delivery System -The SUMMIT Registry

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Provascular GmbH · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The intent of this clinical registry is to demonstrate the efficacy of the EPIC™ stent in patients with superficial femoral/ popliteal artery disease. 100 patients with symptomatic femoropopliteal artery lesion will be enrolled in the study and shall undergo 4 visits during the trial -a pre-procedure visit, procedure visit at which time the stent will be placed, and follow-up visits at 6 and 12 months. Study hypothesis: The EPIC™ Self-Expanding Nitinol Vascular Stent with Delivery System will be efficacious in patients with Superficial Femoro/Popliteal Artery disease.

Detailed description

The SUMMIT Registry addresses the treatment of peripheral arterial disease (PAD). PAD represents a major challenge to physicians in treating the Superficial Femoral (SFA) and Popliteal arteries. These vessels are exposed to enormous mechanical stress what represents a harsh environment for any endovascular device. During flexing of the knee, the SFA/Popliteal arteries can bend, rotate, elongate and compress dramatically. An ideal stent designed for use in the SFA/Popliteal arteries would offer great ranges of movement while adequately supporting the arteries. Subject of study is the EPIC™ Femoropopliteal Self-Expanding Stent System which provides a great range of motions for a highly flexible femoral artery while adequately supporting the vessel. Primary objective is to evaluate the efficacy of the device in treating lesions of the SFA/Popliteal artery. The project is a multi-centre open label study. Primary efficacy parameter will be assessed by measuring the in-stent binary stenosis using duplex ultrasound at 6 and 12 months after the stent placement. Binary restenosis is defined as a peak systolic velocity ratio (PSVR) ≥2.5:1. Anticipated study duration is 18 months: 6 months recruiting and 12 months follow-up.

Conditions

• Peripheral Arterial Diseases
• Superficial Femoral Artery Stenosis

Interventions

Type	Name	Description
DEVICE	EPIC™ Self-Expanding Nitinol Vascular Stent	SFA/Popliteal Artery stenting

Timeline

• Start date: 2011-04-01
• Primary completion: 2012-09-01
• Completion: 2012-11-01
• First posted: 2011-04-15
• Last updated: 2014-04-24

Locations

4 sites across 1 country: Germany