Evaluation of Efficacy of the EPIC™ Self-Expanding Nitinol Vascular Stent (SUMMIT)
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|ClinicalTrials.gov Identifier: NCT01336101|
Recruitment Status : Completed
First Posted : April 15, 2011
Last Update Posted : April 24, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Diseases Superficial Femoral Artery Stenosis||Device: EPIC™ Self-Expanding Nitinol Vascular Stent||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Efficacy of the EPIC™ Self-Expanding Nitinol Vascular Stent With Delivery System -The SUMMIT Registry|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||November 2012|
Device: EPIC™ Self-Expanding Nitinol Vascular Stent
SFA/Popliteal Artery stenting
- 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%.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01336101
|Bad Krozingen, Germany, 79189|
|Freital, Germany, 01405|
|Leipzig, Germany, 04289|
|Sonneberg, Germany, 96515|
|Principal Investigator:||Dierk Scheinert||Park-Krankenhaus Leipzig|