A randomized controlled trial evaluating the safety and efficacy of 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

Recruiting

• Conditions: peripheral arterial disease; stenosis or re-stenosis of the common femoral artery; 10003216

• Registration Number: NL-OMON55275
• Lead Sponsor: ID3 Medical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

Clinical inclusion criteria:
CI1. Patient is >=18 years old
CI2. Patient presenting a score from 2 to 4 following Rutherford classification
CI3. Patient is willing to comply with specified follow-up evaluations at the
specified times
CI4. Patient understands the nature of the procedure and provides written
informed consent, prior to enrolment in the study
CI5. Patient has a life expectancy of at least 12 months
CI6. Prior to enrolment, the guidewire has crossed the target lesion in the
endovascular arm. In the surgical arm, the CFE needs to be performed with
primary suture or patch implantation.

Angiographic inclusion criteria
AI1. De novo stenotic or restenotic (post-PTA) lesions (<100%) located in the
common femoral artery, suitable for both endovascular therapy and endarterectomy
AI2. 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)
AI3. There is angiographic evidence of a patent deep femoral artery and/or
superficial femoral artery
AI4. The target lesion has angiographic evidence of >50% stenosis. Occlusions
are not allowed

Exclusion Criteria

Clinical exclusion criteria
CE1. Presence of another stent in the target vessel that was placed during a
previous procedure
CE2. Previous open surgery in the ipsilateral groin
CE3. Patients contraindicated for antiplatelet therapy, anticoagulants or
thrombolytics
CE4. Patients who exhibit persistent acute intraluminal thrombus at the target
lesion site
CE5. 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
CE6. Known allergy to contrast media that cannot be adequately pre-medicated
prior to study procedure
CE7. Patients with uncorrected bleeding disorders
CE8. Female patients with child bearing potential not taking adequate
contraceptives or currently breastfeeding
CE9. Ipsilateral inflow (aorto-iliac) artery treatment before target lesion
treatment with a residual stenosis >30%
CE10. Use of thrombectomy, atherectomy or laser device during procedure
CE11. Any patient considered to be hemodynamically unstable at onset of
procedure
CE12. Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic
malignancy, dementia, etc.) or other medical condition that would prelude non
compliance with the study protocol or 1-year life expectancy
CE13. Major distal amputation (above the ankle) in the study limb or non-study
limb

Angiographic exclusion criteria
AE1. Target lesion involves an (pseudo-)aneurysm or is adjacent to an
(pseudo-)aneurysm (within 5mm)
AE2. 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
AE3. Presence of an aortic, iliac or femoral artificial graft
AE4. Occlusion in the target lesion
AE5. Presence of an interposition graft with/without profunda reimplantation

Study & Design

• Study Type: Interventional
• Study Design: Not specified