Actively 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
Led by ID3 Medical · Updated on 2024-10-16
286
Participants Needed
13
Research Sites
434 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 classification 2,3 or 4 with a Supera Vascular Mimetic Implant of Abbott, compared to classic surgical common femoral artery endarterectomy. The Supera Vascular Mimetic Implant has an interwoven design and has a high crush resistance and is, when correctly implanted, an ideal stent to treat eccentric calcified plaques in the CFA. An expected total of 143 patients will be treated with the Vascular Mimetic Implant of Abbott and compared to a control group of another 143 patients that will be treated with classic surgical endarterectomy of the common femoral artery. Assignment to the treatment groups will be at random. Patients will be invited for a follow-up visit at 1, 6, 12, 24 and 36 months post-procedure. The primary efficacy endpoint is defined as follows: freedom from clinically-driven target lesion revascularization and binary restenosis at 12 months. The primary safety endpoint is defined as follows: a composite of overall death, cardiac, pulmonary, renal complications, sepsis, target lesion revascularisation and wound related complications through 30 days post-index procedure. The secondary endpoints are defined as technical success, primary patency in the deep femoral artery, primary patency in the target lesion, target lesion revascularisation, target vessel revascularisation, binary restenosis, duration of initial hospital stay, sustained clinical improvement, change of walking impairment questionnaire score from baseline, change in target limb Rutherford classification, change in target limb ABI/TBI from baseline, all cause death, thrombosis at the target lesion through 6, 12, 24 and 36 months post-procedure.
CONDITIONS
Official 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 or older
- Patient has a Rutherford classification score from 2 to 4
- Patient is willing to comply with scheduled follow-up visits
- Patient understands the procedure and provides written informed consent
- Patient has a life expectancy of at least 12 months
- Successful guidewire passage through target lesion in endovascular group
- Endarterectomy performed with primary suture or patch implantation in surgical group
- Lesions are de novo stenotic or restenotic (less than 100%) in the common femoral artery suitable for both treatments
- Target lesion is located within the native common femoral artery between 1cm proximal to the circumflex iliac artery and proximal 2cm of superficial and deep femoral arteries
- Angiographic evidence of a patent deep femoral artery and/or superficial femoral artery
- Target lesion shows more than 50% stenosis; occlusions are excluded
You will not qualify if you...
- Presence of another stent in the target vessel from previous procedures
- Previous open surgery in the same groin area
- Contraindication to antiplatelet therapy, anticoagulants, or thrombolytics
- Persistent acute intraluminal thrombus at the target lesion
- Known allergy to nickel-titanium or heparin, including heparin-induced thrombocytopenia type II
- Allergy to contrast media that cannot be properly pre-medicated
- Uncorrected bleeding disorders
- Female patients of childbearing potential not using adequate contraceptives or currently breastfeeding
- Ipsilateral inflow artery treatment before target lesion treatment with residual stenosis over 30%
- Use of thrombectomy, atherectomy, or laser devices during procedure
- Hemodynamically unstable at procedure start
- Severe medical conditions that prevent study compliance or reduce life expectancy below 1 year
- Major distal amputation above the ankle in either limb
- Target lesion involving or near an aneurysm (within 5mm)
- Iliac artery disease requiring treatment unless successfully treated first during procedure
- Presence of aortic, iliac, or femoral artificial graft
- Occlusion in the target lesion
- Presence of interposition graft with or without profunda reimplantation
AI-Screening
AI-Powered Screening
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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
CONTACT
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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