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Trial record 1 of 1 for:    VMI-CFA
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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

Tracking Information
First Submitted Date  ICMJE June 14, 2016
First Posted Date  ICMJE June 17, 2016
Last Update Posted Date September 18, 2017
Study Start Date  ICMJE April 2016
Estimated Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2016)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2016)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial Investigating the Efficacy of the Supera Peripheral Stent System for the Treatment of the Common Femoral Artery
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Arterial Disease
Intervention  ICMJE Device: Supera Peripheral Stent System
Study Arms  ICMJE Experimental: Supera Peripheral Stent System
Intervention: Device: Supera Peripheral Stent System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 14, 2016)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2018
Estimated Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02804113
Other Study ID Numbers  ICMJE iD3 Medical - 160226
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ID3 Medical
Study Sponsor  ICMJE ID3 Medical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Koen Deloose, MD ID3 Medical
PRS Account ID3 Medical
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP