Actively Recruiting
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
13
Research Sites
104 weeks
Total Duration
On this page
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
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
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for informed consent, medical history, physical exam, blood tests, and initial assessments
Duration - Index procedure day
Participants undergo either endovascular treatment with the Supera Peripheral Stent System or surgical endarterectomy to treat stenotic or restenotic lesions of the common femoral artery.
1 visit (in-person) for the treatment procedure
Duration - Up to 36 months
Participants are monitored over time to assess the safety and efficacy of their treatment, including physical exams, medication recording, walking impairment questionnaires, and imaging assessments.
Follow-up visits at 1, 6, 12, 24, and 36 months (in-person)
Trial Site Locations
Total: 13 locations
1
O.L.V. Hospital
Aalst, Belgium, 9300
Actively Recruiting
2
Imelda Hospital
Bonheiden, Belgium, 2820
Actively Recruiting
3
A.Z. Sint-Blasius
Dendermonde, Belgium, 9200
Actively Recruiting
4
Z.O.L.
Genk, Belgium, 3600
Actively Recruiting
5
Az Groeninge
Kortrijk, Belgium, 8500
Actively Recruiting
6
AZ Sint-Maarten
Mechelen, Belgium, 2800
Not Yet Recruiting
7
A.Z. Jan Portaels
Vilvoorde, Belgium, 1800
Actively Recruiting
8
Maastricht UMC+
Maastricht, Limburg, Netherlands, 6229
Actively Recruiting
9
Dijklander hospital
Hoorn, North Holland, Netherlands, 1624
Actively Recruiting
10
St Antonius Hospital
Utrecht, Utrecht, Netherlands, 3543
Actively Recruiting
11
Noordwest ziekenhuisgroep
Alkmaar, Netherlands, 1815
Actively Recruiting
12
Bonifraterskie Centrum Medyczne
Krakow, Poland, 31-061
Actively Recruiting
13
Karol Marcinkowski Medical University
Poznan, Poland, 61-848
Actively Recruiting
Research Team
S
Sofie Vercauteren, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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