Clinical Trial Investigating the Efficacy of the Supera Peripheral Stent System for the Treatment of the Common Femoral Artery

Peripheral Arterial Disease Clinical Trial

— VMI-CFA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02804113
• Other study ID #: iD3 Medical - 160226
• Status: Completed
• Phase: N/A
• Start date: April 25, 2016
• Est. completion date: October 30, 2019

Study information

• Verified date: January 2021
• Source: ID3 Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 30, 2019
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• Supera Peripheral Stent System

Locations

Country	Name	City	State
Belgium	OLV Ziekenhuis Aalst	Aalst	Oost-Vlaanderen
Belgium	ZNA Stuivenberg	Antwerpen	Antwerp
Belgium	Imelda Hospital	Bonheiden
Belgium	AZ Sint-Blasius	Dendermonde	Oost-Vlaanderen
France	Clinique Rhone Durance	Avignon
France	CHU de Clermont-Ferrand	Clermont-Ferrand
France	CHU de Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
ID3 Medical

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary patency at 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.	12 months
Primary	Periprocedural adverse events	periprocedural adverse events up to 30 days post procedure, as defined per ISO 14155:2011	30 days post procedure
Secondary	Technical success	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.	during indexprocedure
Secondary	Primary patency rate at 1, 6 and 24 month	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.	1, 6 and 24 month post procedure
Secondary	Freedom from TLR until 24 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	until 24 month post procedure
Secondary	Clinical success	an improvement of Rutherford classification at 1-, 6-, 12- and 24-month follow-up of one class or more as compared to the pre-procedure Rutherford classification.	1, 6, 12 and 24 month follow-up