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Clinical Trial Investigating the Efficacy of the Supera Peripheral Stent System for the Treatment of the Common Femoral Artery (VMI-CFA)

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ClinicalTrials.gov Identifier: NCT02804113
Recruitment Status : Unknown
Verified September 2017 by ID3 Medical.
Recruitment status was:  Active, not recruiting
First Posted : June 17, 2016
Last Update Posted : September 18, 2017
Sponsor:
Information provided by (Responsible Party):
ID3 Medical

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 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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: Supera Peripheral Stent System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Arm Intervention/treatment
Experimental: Supera Peripheral Stent System Device: Supera Peripheral Stent System



Primary Outcome Measures :
  1. 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.

  2. 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 :
  1. 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.

  2. 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.

  3. 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

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02804113


Locations
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Belgium
ZNA Stuivenberg
Antwerpen, Antwerp, Belgium, 2060
OLV Ziekenhuis Aalst
Aalst, Oost-Vlaanderen, Belgium, 9300
AZ Sint-Blasius
Dendermonde, Oost-Vlaanderen, Belgium, 9200
Imelda Hospital
Bonheiden, Belgium, 2820
France
Clinique Rhone Durance
Avignon, France, 84000
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63003
CHU de Nantes
Nantes, France, 44093
Sponsors and Collaborators
ID3 Medical
Investigators
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Study Director: Koen Deloose, MD ID3 Medical
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Responsible Party: ID3 Medical
ClinicalTrials.gov Identifier: NCT02804113    
Other Study ID Numbers: iD3 Medical - 160226
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: September 18, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases