Evaluating a new stent for treating blocked arteries in the leg

An RCT 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

This study tests a new stent for blocked leg arteries to see if it works better and is safer than traditional surgery for patients with artery problems.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 286 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: ID3 Medical (Academic / other)
• Locations: 13 sites (Aalst and 12 other locations)
• Trial ID: NCT04349657 on ClinicalTrials.gov

What this trial studies

This clinical investigation assesses the safety and efficacy of the Supera Vascular Mimetic Implant for treating stenotic or restenotic lesions in the common femoral artery. A total of 286 patients will be randomly assigned to receive either the Supera stent or traditional surgical endarterectomy. The study aims to demonstrate that the endovascular treatment is not only as effective but also safer than the surgical approach. Patients will undergo follow-up visits at multiple intervals post-procedure to monitor outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with Rutherford classification scores of 2 to 4, indicating varying degrees of limb ischemia.

Not a fit: Patients with life expectancies of less than 12 months or those with severe comorbidities that prevent participation in follow-up evaluations may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a less invasive option for patients with peripheral arterial disease, potentially leading to quicker recovery times and fewer complications.

How similar studies have performed: Previous studies have shown promising results with endovascular treatments for peripheral arterial disease, suggesting that this approach may be effective.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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

Where this trial is running

Aalst and 12 other locations

• O.L.V. Hospital — Aalst, Belgium (Recruiting)
• Imelda Hospital — Bonheiden, Belgium (Recruiting)
• A.Z. Sint-Blasius — Dendermonde, Belgium (Recruiting)
• Z.o.l. — Genk, Belgium (Recruiting)
• Az Groeninge — Kortrijk, Belgium (Recruiting)
• AZ Sint-Maarten — Mechelen, Belgium (Not_yet_recruiting)
• A.Z. Jan Portaels — Vilvoorde, Belgium (Recruiting)
• Maastricht UMC+ — Maastricht, Limburg, Netherlands (Recruiting)
• Dijklander hospital — Hoorn, North Holland, Netherlands (Recruiting)
• St Antonius Hospital — Utrecht, Utrecht, Netherlands (Recruiting)
• Noordwest ziekenhuisgroep — Alkmaar, Netherlands (Recruiting)
• Bonifraterskie Centrum Medyczne — Krakow, Poland (Recruiting)
• Karol Marcinkowski Medical University — Poznan, Poland (Recruiting)

Study contacts

• Principal investigator: Koen Deloose, MD — A.Z. Sint-Blasius
• Study coordinator: Sofie Vercauteren, MSc

Conditions Peripheral Arterial Disease