Evaluation of Efficacy of the EPIC™ Self-Expanding Nitinol Vascular Stent (SUMMIT)
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.
|Peripheral Arterial Diseases Superficial Femoral Artery Stenosis||Device: EPIC™ Self-Expanding Nitinol Vascular Stent|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of Efficacy of the EPIC™ Self-Expanding Nitinol Vascular Stent With Delivery System -The SUMMIT Registry|
- efficacy of the EPIC™ Stent as measured by the in-stent binary restenosis using duplex ultrasound (DUS) [ Time Frame: at 6 months after procedure ]Binary restenosis is defined as a peak systolic velocity ratio (PSVR) ≥2.5:1.
- efficacy of the EPIC™ Stent as measured by the in-stent binary restenosis using duplex ultrasound (DUS) [ Time Frame: at 12 months after procedure ]Binary restenosis is defined as a peak systolic velocity ratio (PSVR) ≥2.5:1.
- Technical Success [ Time Frame: after stent placement intra-procedural via angiographic images (day 1) ]defined as the ability to implant the stent with a residual angiographic stenosis no greater than 30%.
|Study Start Date:||April 2011|
|Study Completion Date:||November 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Device: EPIC™ Self-Expanding Nitinol Vascular Stent
SFA/Popliteal Artery stenting
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01336101
|Bad Krozingen, Germany, 79189|
|Freital, Germany, 01405|
|Leipzig, Germany, 04289|
|Sonneberg, Germany, 96515|
|Principal Investigator:||Dierk Scheinert||Park-Krankenhaus Leipzig|