Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System (OPEN)
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|ClinicalTrials.gov Identifier: NCT01355406|
Recruitment Status : Active, not recruiting
First Posted : May 18, 2011
Last Update Posted : October 17, 2017
This is a clinical study of a new self-expanding stent (FlexStent®) designed specifically to cope with the extreme demands of the superficial femoral artery (SFA)/proximal popliteal artery. The arteries are often abbreviated as femoropopliteal.
The intent of this study is to demonstrate that the FlexStent® Femoropopliteal Self-Expanding Stent System is safe and effective for the treatment of patients with peripheral arterial disease. Specifically, the FlexStent® shall meet or exceed the proposed safety and efficacy performance goals established for Femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease.
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Artery Disease Peripheral Vascular Disease Vascular Disease Cardiovascular Diseases PAD||Device: FlexStent® Femoropopliteal Self Expanding Stent System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||257 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System Study|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||January 2016|
|Estimated Study Completion Date :||March 2018|
This is a prospective single-arm multi-center clinical trial designed to evaluate the safety and efficacy of the Flexible Stenting Solutions Flext Stent® Femoropopliteal stenting system in subjects with lower limb peripheral arterial desease (PAD). Subjects targeted for enrollment must have a single de-novo lesion located in the superficial femoral artery and/or proximal popliteal artery with at > 70% stenosis. Subjects must meet all enrollment criteria and provide written informed consent prior to participation in the study.
Device: FlexStent® Femoropopliteal Self Expanding Stent System
Transcatheter over guidewire placement of an intravascular stent(s)
- The primary safety endpoint is freedom from all cause death, TLR, or index limb amputation through 30 days. [ Time Frame: 30 Days ]The primary safety endpoint is defined as freedom from all cause death, index limb amputation and target lesion revascularization (TLR) through 30 days. The proportion of patients remaining free from this composite endpoint will be compared to a safety performance goal for bare nitinol stents.
- The primary efficacy endpoint is vessel patency at 12 months. [ Time Frame: 12 Months ]The primary efficacy endpoint is vessel patency at 12 months. Vessel patency is defined as freedom from a greater than 50% restenosis in the stented segment as determined by the DUS peak systolic velocity ratio (PSVR) comparing data within the treated segment to the proximal normal arterial segment and freedom from clinically-driven TLR within the stented segment within 1 year of the procedure.
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): NCT01355406
Show 38 Study Locations
|Principal Investigator:||William A. Gray, MD||Center for Interventional Vascular Therapy / Columbia University Medical Center|