Status:
RECRUITING
A Study Evaluating the Endovascular Treatment of Subjects with Stenotic or Restenotic Lesions of the Common Femoral Artery with the Supera Vascular Mimetic Implant Compared to Surgical Common Femoral Artery Endarterectomy
Lead Sponsor:
ID3 Medical
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The SUPERSURG RCT trial investigates the efficacy and safety of the endovascular treatment of stenosis or restenosis in the common femoral artery (CFA) of patients presenting with Rutherford classific...
Detailed Description
The objective of this clinical investigation is to assess the safety and efficacy of the Supera Vascular Mimetic Implant for the treatment of stenotic or restenotic lesions of the common femoral arter...
Eligibility Criteria
Inclusion
- Patient is ≥18 years old
- 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 understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
- Patient has a life expectancy of at least 12 months
- Prior to enrolment, the guidewire has crossed the target lesion in the endovascular arm. In the surgical arm, the endarterectomy needs to be performed with primary suture or patch implantation
- De novo stenotic or restenotic (post-PTA) lesions (\<100%) located in the common femoral artery, suitable for both endovascular therapy and endarterectomy
- Target lesion is located within the native CFA: localized between 1cm proximal to the origin of the circumflex iliac artery and the proximal (2cm) superficial femoral artery and deep femoral artery (2cm) (Azéma type 2 and 3 lesions)
- There is angiographic evidence of a patent deep femoral artery and/or superficial femoral artery
- The target lesion has angiographic evidence of \>50% stenosis. Occlusions are not allowed.
Exclusion
- Presence of another stent in the target vessel that was placed during a previous procedure
- Previous open surgery in the ipsilateral groin
- Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics
- Patients who exhibit persistent acute intraluminal thrombus at the target lesion site
- 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
- Known allergy to contrast media that cannot be adequately pre-medicated prior to study procedure
- Patients with uncorrected bleeding disorders
- Female patients 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 device during procedure
- Any patient considered to be hemodynamically unstable at onset of procedure
- Severe medical comorbidities (untreated coronary artery disease/congestive heart failure, severe chronic obstructive pulmonary disease, metastatic malignancy, dementia, etc.) or other medical condition that would prelude compliance with the study protocol or 1-year life expectancy
- Major distal amputation (above the ankle) in the study limb or non-study limb
- Target lesion involves an (pseudo-)aneurysm or is adjacent to an (pseudo-)aneurysm (within 5mm)
- Iliac inflow disease requiring treatment, unless the iliac artery disease is successfully treated first during the index procedure. Success is defined as ≤30% residual diameter stenosis without death or major complications
- Presence of an aortic, iliac or femoral artificial graft
- Occlusion in the target lesion
- Presence of an interposition graft with/without profunda reimplantation
Key Trial Info
Start Date :
May 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
286 Patients enrolled
Trial Details
Trial ID
NCT04349657
Start Date
May 5 2020
End Date
September 1 2028
Last Update
October 16 2024
Active Locations (13)
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1
O.L.V. Hospital
Aalst, Belgium, 9300
2
Imelda Hospital
Bonheiden, Belgium, 2820
3
A.Z. Sint-Blasius
Dendermonde, Belgium, 9200
4
Z.O.L.
Genk, Belgium, 3600