A Phase 4 interventional study of nitinol stent in Peripheral Arterial Disease, sponsored by Flanders Medical Research Program. Completed at 4 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-10-01.
Sponsored by Flanders Medical Research Program · Phase 4, Interventional, and Treatment
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.
1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.
This study's enrollment of 60 is below the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Flanders Medical Research Program is the lead sponsor of 24 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
General Inclusion criteria
Angiographic Inclusion Criteria
Exclusion Criteria:
Protégé EverFlex stent
Device: nitinol stent
implantation of one Protégé EverFlex stent
Also known as: Protégé EverFlex stent
primary patency
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
Time frame: 12 months post-procedure
Technical success
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
Time frame: 1 day post-procedure
Primary patency rate at 6-, 12-month follow-up.
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.
Time frame: 6-, 12-month follow-up
Clinical success
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.
Time frame: 6-, 12-month follow-up
tent fracture rate at 12-month follow-up
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)
Time frame: 12-month follow-up
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.
Time frame: 1 year
This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
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Flanders Medical Research Program