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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Arterial Disease
- Sponsor
- ID3 Medical
- Enrollment
- 286
- Locations
- 13
- Primary Endpoint
- Primary safety endpoint at 30 days post-index procedure
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
The objective of this clinical investigation is to assess the safety and efficacy of the Supera Vascular Mimetic Implant for the treatment of stenotic or restenotic lesions of the common femoral artery. Furthermore, a non-inferiority hypothesis in terms of efficacy and a superiority in terms of safety will be tested with the endovascular treatment with Supera compared to surgical endarterectomy of the common femoral artery. The patients will be selected based on the investigator's assessment, evaluation of the underlying disease and the eligibility criteria. The patient's medical condition should be stable, with no underlying medical condition which would prevent them from performing the required testing or from completing the study. Patients should be geographically stable, willing and able to cooperate in this clinical study, and remain available for long term follow-up. The patient is considered enrolled in the study after obtaining the patients informed consent, if there is full compliance with the study eligibility criteria and after successful guidewire passage through the study target lesion. Prior to the index procedure the following will be collected: an informed consent for data collection, demographics, medical history, medication record, physical examination, clinical category of acute limb ischemia (Rutherford category), the resting ankle-brachial index (ABI) or toe-brachial index (TBI), blood sample test (complete blood count, comprehensive metabolic panel and if applicable pregnancy test) and a walking impairment questionnaire. Randomization will also occur prior to the procedure. During the procedure patients that are randomized within the endarterectomy group will be treated according to the institutions standard of care. For patients that are randomized within the Supera arm, the guidewire will cross the entire study lesion after which the lesion will be assessed through angiography. Pre-dilatation of the target lesion with an uncoated PTA-balloon is mandatory and will be followed by stenting with the Supera stent according to the instructions for use. Postdilatation of the stent is allowed but not mandatory. The regular follow-up is necessary to monitor the condition of the patient and the results of the procedure. The patients will be invited for the following required follow-up visits at 1, 6, 12, 24 and 36 months. During these visit the following data will be collected: medication record, physical exam, target limb ABI/TBI and Rutherford classification, duplex ultrasound of target vessel, walking impairment questionnaire and possible adverse events.
Investigators
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
Outcomes
Primary Outcomes
Primary safety endpoint at 30 days post-index procedure
Time Frame: 30 days post-index-procedure
To demonstrate superior safety in the group treated with the Supera stent compared to the endarterectomy group for the treatment of atherosclerosis in the CFA. Safety is defined as a composite of overall death, cardiac, pulmonary, renal complications, sepsis, target lesion revascularization (TLR) and wound-related complications (haematoma, seroma, lymphocele, lymphatic leaks with lymphatic fistula, surgical site infections (SSIs) (Szilagyi grade I, II and III)).
Primary efficacy endpoint at 12 months: Primary patency
Time Frame: 12 months post-index-procedure
To demonstrate the non-inferior efficacy in the group treated with the Supera stent compared to the group treated with endarterectomy for the treatment of atherosclerosis in the common femoral artery (CFA). Efficacy is defined as primary patency: freedom from restenosis defined as duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≥2.4 or ≥50% stenosis as assessed by an independent DUS core lab in CFA without a previous target lesion revascularization through 12 months post-index procedure.
Secondary Outcomes
- Duration of initial hospitalisation stay(Up to 4 weeks)
- Technical success: post-procedure residual stenosis <30%(Index procedure)
- Sustained clinical improvement at 6-, 12-, 24- and 36-months post-index procedure(6, 12, 24 and 36 months post-index-procedure)
- All cause death at 6, 12, 24 and 36 months(6, 12, 24 and 36 months post-index-procedure)
- Primary patency in the deep femoral artery (DFA), post-index procedure and at 6-, 12-, 24- and 36-months post-index procedure(6, 12, 24 and 36 months post-index-procedure)
- Primary patency at 6, 24 and 36 months(6, 24 and 36 months post-index-procedure)
- TLR at 6-, 12-, 24- and 36-months post-index procedure(6, 12, 24 and 36 months post-index-procedure)
- Binary restenosis at 6, 12, 24 and 36 months(6, 12, 24 and 36 months post-index-procedure)
- Thrombosis at the target lesion at 6, 12, 24 and 36 months(6, 12, 24 and 36 months post-index-procedure)
- Change in Walking Impairment Questionnaire (WIQ) score from baseline to 6, 12, 24 and 36 months(6, 12, 24 and 36 months post-index-procedure)
- TVR at 6-, 12-, 24- and 36-months post-index procedure(6, 12, 24 and 36 months post-index-procedure)
- Change in target limb Rutherford class from baseline to 6, 12, 24 and 36 months(6, 12, 24 and 36 months post-index-procedure)
- Change in target limb resting ABI or TBI from baseline to 6, 12, 24 and 36 months(6, 12, 24 and 36 months post-index-procedure)