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

NCT02804113 | Completed

• 1 other identifier: iD3 Medical - 160226
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 7

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (2)

• 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

• Periprocedural adverse events

  periprocedural adverse events up to 30 days post procedure, as defined per ISO 14155:2011

  30 days post procedure

Secondary Outcomes (4)

• Technical success

  during indexprocedure

• Primary patency rate at 1, 6 and 24 month

  1, 6 and 24 month post procedure

• Freedom from TLR until 24 month post procedure

  until 24 month post procedure

• Clinical success

  1, 6, 12 and 24 month follow-up

Study Arms (1)

Supera Peripheral Stent System

EXPERIMENTAL

Device: Supera Peripheral Stent System

Interventions

Supera Peripheral Stent System DEVICE

Supera Peripheral Stent System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ID3 Medical: lead

Study Sites (7)

ZNA Stuivenberg

Antwerp, Antwerp, 2060, Belgium

Location

OLV Ziekenhuis Aalst

Aalst, Oost-Vlaanderen, 9300, Belgium

Location

AZ Sint-Blasius

Dendermonde, Oost-Vlaanderen, 9200, Belgium

Location

Imelda Hospital

Bonheiden, 2820, Belgium

Location

Clinique Rhone Durance

Avignon, 84000, France

Location

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

CHU de Nantes

Nantes, 44093, France

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Koen Deloose, MD

  ID3 Medical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2016
• First Posted: June 17, 2016
• Study Start: April 25, 2016
• Primary Completion: June 30, 2018
• Study Completion: October 30, 2019
• Last Updated: January 6, 2021

Record last verified: 2021-01

Locations

BE (4); FR (3)