Efficacity Study With the Protégé EverFlex Stent in Popliteal Lesions (DUR-POP)
This study will assess the results up to 12 months with the Protégé EverFlex stent (ev3) in patients presenting with a narrowing or blocking at the level of the knee artery, which leads to a limited walking distance, rest pain or non-healing ulcers.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||DURABILITY-POP Study - Physician Initiated Trial Investigating the Efficacy of the Implant of Protégé EverFlex Nitinol Stents in Popliteal Lesions|
- primary patency [ Time Frame: 12 months post-procedure ] [ Designated as safety issue: No ]primary patency at 12 months, defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.4) and without TLR within 12 months
- Technical success [ Time Frame: 1 day post-procedure ] [ Designated as safety issue: No ]Technical success, defined as the ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30% and residual stenosis less than 50% by duplex imaging
- Primary patency rate at 6-, 12-month follow-up. [ Time Frame: 6-, 12-month follow-up ] [ Designated as safety issue: No ]Patients that present without a hemodynamically significant stenosis at the target area on duplex ultrasound (systolic velocity ratio no greater than 2.4) and without prior TLR are defined as being primary patent.
- Clinical success [ Time Frame: 6-, 12-month follow-up ] [ Designated as safety issue: No ]Clinical success at follow-up is defined as an improvement of Rutherford classification at 6-, 12-month follow-up of one class or more as compared to the pre-procedure Rutherford classification.
- tent fracture rate at 12-month follow-up [ Time Frame: 12-month follow-up ] [ Designated as safety issue: No ]Determined according the following classification on x-ray: Class 0 (no strut factures); Class I (single tine fracture); Class II (multiple tine factures); Class III (Stent fracture(s) with preserved alignment of the components); Class IV (Stent fracture(s) with mal-alignment of the components); Class V (Stent fracture(s) in a trans-axial spiral configuration)
- Serious adverse events [ Time Frame: 1 year ] [ Designated as safety issue: No ]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.
|Study Start Date:||July 2010|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Experimental: nitinol stent
Protégé EverFlex stent
Device: nitinol stent
implantation of one Protégé EverFlex stent
Other Name: Protégé EverFlex stent
Please refer to this study by its ClinicalTrials.gov identifier: NCT01412450
|Bonheiden, Antwerp, Belgium, 2820|
|University Hospital Antwerp|
|Edegem, Antwerp, Belgium, 2650|
|Dendermonde, East-Flanders, Belgium, 9200|
|Tienen, Flemish Brabant, Belgium, 3300|
|Principal Investigator:||Marc Bosiers, MD||A.Z. Sint-Blasius|