DURABILITY+ : a Prospective, Multi-center, Controlled Study With the Everflex+ Stent in SFA Lesions (DURABILITY+)
|ClinicalTrials.gov Identifier: NCT01412463|
Recruitment Status : Completed
First Posted : August 9, 2011
Last Update Posted : October 1, 2013
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease||Device: stent placement||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||DURABILITY+ : a Prospective, Multi-center, Controlled Study Measuring the Durability in Lesions of the Superficial Femoral Artery of the Protégé Everflex+ Stent|
|Study Start Date :||May 2011|
|Primary Completion Date :||January 2013|
|Study Completion Date :||January 2013|
Experimental: Protégé EverFlex+
Stenting with Protégé EverFlex+
Device: stent placement
Other Name: Protégé EverFlex+
- Major Adverse Event rate [ Time Frame: 30 days post-procedure ]The primary safety endpoint of the study is the Major Adverse Event (MAE) rate at 30 days. MAE is defined as: clinically-driven target lesion revascularization, amputation of treated limb or all-cause mortality through 30 days post procedure.
- Primary stent patency [ Time Frame: 12 months post-procedure ]The primary effectiveness endpoint of the study is primary stent patency at 12 months. Primary patency is defined as absence of a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.4) at the target lesion and without TLR within 12 months.
- Technical success [ Time Frame: 1 day post-procedure ]Technical success, defined as the ability to cross and stent the lesion, after predilation, and with or without additional post-dilation, and achieve residual angiographic stenosis no greater than 30%
- Primary stent patency at 1 and 6 months [ Time Frame: 1 and 6 months post-procedure ]Primary patency at 1, 6 months. Primary patency is defined as absence of a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.4) at the target lesion and without TLR within the time of procedure and the given follow-up.
- Primary assisted patency [ Time Frame: 1, 6 and 12 months post-procedure ]Primary assisted patency rate at 1, 6, 12-month follow-up. Defined as flow through the treated lesion maintained by repeat percutaneous intervention completed prior to complete vessel closure.
- Secondary patency [ Time Frame: 1, 6 and 12 months post-procedure ]Secondary patency rate at 1, 6, 12-month follow-up. Defined as flow through the treated lesion maintained by repeat percutaneous intervention after occlusion of the target lesion.
- Target lesion revascularization [ Time Frame: 12 months post-procedure ]Target lesion revascularization (TLR) is defined as a repeat intervention, within the study follow-up period of 12 months, to maintain or re-establish patency within the region of the treated arterial vessel plus 5 mm proximal and distal to the treated lesion edge.
- limb-salvage [ Time Frame: 12-months post-procedure ]Limb-salvage rate at all follow-up visits for the subgroup of patients with critical limb ischemia (Rutherford category 4), defined as absence of major amputation. Major amputation is defined as amputation at or above the ankle, as opposed to minor amputation, being an amputation at or below metatarsal level, preserving functionality of the foot)
- Clinical success [ Time Frame: 1, 6 and 12 months post-procedure ]Clinical success at follow-up, defined as an improvement of Rutherford classification at 1 day and 1, 6, 12-month follow-up of one class or more as compared to the pre-procedure Rutherford classification
- Serious adverse events [ Time Frame: 12-months post-procedure ]Serious adverse events defined as any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; resulted in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01412463
|Bonheiden, Antwerp, Belgium, 2820|
|University Hospital Antwerp|
|Edegem, Antwerp, Belgium, 2650|
|Dendermonde, East-Flanders, Belgium, 9200|