Clinical trial NCT02804113: Clinical Trial Investigating the Efficacy of the Supera Peripheral Stent System for the Treatment of the Common Femoral Artery
Official title: VMI-CFA Study: Physician-initiated Trial Investigating the Efficacy of the Vascular Mimetic Implant Supera Peripheral Stent System for the Treatment of the Common Femoral Artery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: ID3 Medical
Sponsor class: OTHER
First posted: 2016-06-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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, 12 and 24 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 and 24 month, freedom from TLR at 1-, 6-, 12 and 24 month follow-up and clinical success at 1-, 6-, 12- and 24-month follow-up.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Primary patency at 12 months
timeFrame: 12 months
measure: Periprocedural adverse events
timeFrame: 30 days post procedure
Secondary outcomes:
measure: Technical success
timeFrame: during indexprocedure
measure: Primary patency rate at 1, 6 and 24 month
timeFrame: 1, 6 and 24 month post procedure
measure: Freedom from TLR until 24 month post procedure
timeFrame: until 24 month post procedure
measure: Clinical success
timeFrame: 1, 6, 12 and 24 month follow-up
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: ZNA Stuivenberg
state: Antwerp
city: Aalst
country: Belgium
facility: OLV Ziekenhuis Aalst
state: Oost-Vlaanderen
city: Dendermonde
country: Belgium
facility: AZ Sint-Blasius
state: Oost-Vlaanderen
city: Bonheiden
country: Belgium
facility: Imelda Hospital
city: Avignon
country: France
facility: Clinique Rhone Durance
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
affiliation: ID3 Medical
name: Koen Deloose, MD
role: STUDY_DIRECTOR
References: