What is the Supera Vascular Mimetic Implant studying for peripheral arterial disease?

The study is evaluating the safety and effectiveness of the Supera Vascular Mimetic Implant in treating narrowing or blockage of the common femoral artery compared to traditional surgical methods. Researchers want to see if this implant can provide similar or better results with fewer complications. The trial is sponsored by ID3 Medical and involves random assignment to treatment groups.

Who may be eligible for this peripheral arterial disease clinical trial?

Adults aged 18 or older with moderate to severe disease (Rutherford score 2 to 4) may qualify. Participants must be willing to attend follow-up visits and have a stable medical condition. People with prior stents in the target artery or certain allergies or medical conditions are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this peripheral arterial disease clinical trial?

Study-related care, including the implant or surgery and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or lodging expenses.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID04349657

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

Led by ID3 Medical · Updated on 2024-10-16

286

Participants Needed

Research Sites

104 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the Supera Vascular Mimetic Implant for treating narrowing or re-narrowing stenosis or restenosis in the common femoral artery in patients with moderate to severe peripheral arterial disease classified as Rutherford categories 2 to 4. This trial compares the implant to traditional surgical endarterectomy, aiming to see if the implant is at least as effective and safer. The study is randomized and involves patients whose medical condition is stable enough for testing and follow-up. Participants are randomly assigned to receive either the Supera Peripheral Stent System, an endovascular device with a special interwoven design that resists crushing and treats calcified plaques, or undergo classic surgical endarterectomy. Before the procedure, patients undergo tests including blood work, ankle or toe-brachial index measurements, and a walking questionnaire. The implant procedure involves crossing the lesion with a guidewire, balloon pre-dilatation, and stent placement. Surgical patients receive standard care for endarterectomy. Follow-up visits are scheduled at 1, 6, 12, 24, and 36 months after the procedure. During follow-up visits, researchers collect data on medication, physical exams, blood flow indexes, ultrasound of the treated vessel, walking ability, and any complications or adverse events. The main outcomes measured include the success of the treatment in keeping the artery open at 12 months and safety events within 30 days after the procedure. Secondary outcomes include artery patency, revascularization rates, changes in walking ability and limb condition, hospital stay length, and survival up to three years. The total participation duration includes these regular follow-ups over 36 months.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Patient is 18 years old or older
Patient has a Rutherford classification score from 2 to 4
Patient is willing to comply with specified follow-up evaluations
Patient understands the procedure and provides written informed consent
Patient has a life expectancy of at least 12 months
Guidewire has crossed the target lesion before enrollment for endovascular patients
Endarterectomy must be performed with primary suture or patch implantation for surgical patients
De novo stenotic or restenotic lesions less than 100% in the common femoral artery, suitable for both treatments
Target lesion is within specified locations in the native common femoral artery
Angiographic evidence of patent deep femoral artery and/or superficial femoral artery
Target lesion shows more than 50% stenosis; occlusions are not allowed

You will not qualify if you...

Presence of another stent in the target vessel from a previous procedure
Previous open surgery in the ipsilateral groin
Contraindications to antiplatelet therapy, anticoagulants, or thrombolytics
Persistent acute intraluminal thrombus at the target lesion site
Known allergy to nickel-titanium, heparin, or history of heparin-induced thrombocytopenia type II
Allergy to contrast media that cannot be adequately pre-medicated
Uncorrected bleeding disorders
Female patients of childbearing potential not using adequate contraception or breastfeeding
Ipsilateral inflow artery treatment before target lesion with residual stenosis greater than 30%
Use of thrombectomy, atherectomy, or laser device during procedure
Hemodynamically unstable at procedure onset
Severe medical conditions preventing study compliance or life expectancy less than 1 year
Major distal amputation above the ankle in study or non-study limb
Target lesion involving or adjacent to aneurysm within 5mm
Iliac inflow disease requiring treatment unless successfully treated during the procedure
Presence of aortic, iliac, or femoral artificial graft
Occlusion in the target lesion
Presence of an interposition graft with or without profunda reimplantation

Research Team

Sofie Vercauteren, MSc

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