Clinical Trial Investigating the Efficacy of the Supera Peripheral Stent System for the Treatment of the Common Femoral Artery (VMI-CFA)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02804113
Recruitment Status : Unknown
Verified September 2017 by ID3 Medical. Recruitment status was: Active, not recruiting
The VMI-CFA study investigates the efficacy of the Supera Stent in the treatment of common femoral artery stenosis or occlusion. 100 patients will be included with a RF of 2 to 4. The lesion is located within the native CFA and treated with predillation prior to stenting with the Supera Peripheral Stent System. Patients will be invited for a follow-up visit at 1, 6 and 12 month post procedure. The primary endpoint of the study is the primary patency at 12 months and periprocedural events up to 30 days post procedure. Secondary endpoints include technical success, primary patency rate at 1 & 6 month, freedom from TLR at 1-, 6- and 12 month follow-up and clinical success at 1-, 6- & 12-month follow-up.
Primary patency at 12 months [ Time Frame: 12 months ]
freedom from > 50% restenosis as indicated by an independently verified duplex ultrasound peak systolic velocity ratio (PSVR) <2.5 in the target vessel with no reintervention (TLR) within 12 months.
Periprocedural adverse events [ Time Frame: 30 days post procedure ]
periprocedural adverse events up to 30 days post procedure, as defined per ISO 14155:2011
Secondary Outcome Measures :
Technical success [ Time Frame: during indexprocedure ]
ability to cross and stent the lesion to achieve residual angiographic stenosis no greater than 30% and residual stenosis less than 50% by duplex imaging.
Primary patency rate at 1 & 6 month [ Time Frame: 1 and 6 month post procedure ]
freedom from >50% restenosis as indicated by an independently verified duplex ultrasound peak systolic velocity ratio (PSVR) <2.5 in the target vessel with no intervention within 1 and 6 months.
Freedom from TLR until 12 month post procedure [ Time Frame: until 12 month post procedure ]
freedom from a repeat intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5mm proximal and distal to the treated lesion edge at the respective time points
Clinical success [ Time Frame: 1, 6 and 12 month follow-up ]
an improvement of Rutherford classification at 1-, 6- & 12-month follow-up of one class or more as compared to the pre-procedure Rutherford classification.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patient presenting a score from 2 to 4 following Rutherford classification
Patient is willing to comply with specified follow-up evaluations at the specified times
Patient is >18 years old
Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
Patient has a projected life expectancy of at least 12 months
Prior to enrolment, the guidewire has crossed target lesion
De novo lesions located in the common femoral artery, suitable for endovascular therapy
The target lesions are located within the native CFA: localized between the origin of the circumflex iliac artery and the proximal (1cm) superficial femoral artery.
There is angiographic evidence of a patent deep femoral artery
The target lesion has angiographic evidence of stenosis > 50% or occlusion
There is angiographic evidence of at least one-vessel-runoff to the foot, irrespective of whether or not outflow was re-established by means of previous endovascular intervention
Presence of another stent in the target vessel that was placed during a previous procedure
Previous open surgery in the same limb
Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics.
Patients who exhibit persistent acute intraluminal thrombus at the target lesion site.
Perforation at the angioplasty site evidenced by extravasation of contrast medium
Patients with known hypersensitivity to nickel-titanium and heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II
Patients with uncorrected bleeding disorders
Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding
Ipsilateral inflow (aorto-iliac) artery treatment before target lesion treatment with a residual stenosis>30%
Use of thrombectomy, atherectomy or laser devices during procedure
Any planned surgical intervention/procedure 30 days after the study procedure
Any patient considered to be hemodynamically unstable at onset of procedure
Patient is currently participating in another investigational drug or device study that has not reached the primary endpoint.
Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic malignancy, dementia, etc.) or other medical condition that would preclude compliance with the study protocol or 1-year life expectancy
Major distal amputation (above the transmetatarsal) in the study limb or non-study limb
Septicemia or bacteremia
Known allergy to contrast media that cannot be adequately pre-medicated prior to the study procedure