Long Superficial Femoral Artery Stenting With SuperA Interwoven Nitinol Stents
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Nantes University Hospital
- Enrollment
- 335
- Locations
- 2
- Primary Endpoint
- Number of patient with improvement of at least one category of Rutherford classification
Study Overview
Brief Summary
Endovascular treatment with stenting is currently used in the treatment of femoro-popliteal lesions. This technique tends to extend to lesions for which the gold standard remains until now the open surgery treatment (lesions TASC C and D).
The primary objective of the study was to evaluate the clinical efficacy at 12 months of the SuperA stent (Abbott) in the treatment of long de novo atherosclerotic lesions TASC C and D in patients with symptomatic peripheral arterial disease. The secondary objectives are to evaluate the clinical effectiveness of the SuperA stent at 24 months, according to clinical, morphological and haemodynamic criteria, the possible influence of calcifications and the quality of life of patients.
The SuperA stent treatment is not specifically provided for by the Protocol but is carried out within the framework of the care. This study is an observationnal study.
Detailed Description
Patient will be recruiting during 1 year. Patient will be followed in the study during 2 years. Pre-operative exams are collected. Patients are asked to give their oral authorization to participate in the study by their surgeon.
Patient can be included up to the next day of the intervention.
Endovascular treatment of femoropopliteal lesion with SuperA stents during medical care:
Intervention will be achieved in operative room, under local anesthesia and sedation or general anesthesia. An angio-CT or an arteriography is necessary to attest the presence for TASC C or D lesion involving the superficial femoral and/or popliteal arteries.
The long femoropopliteal lesion must be pre-dilated during 3 minutes with a balloon of 1mm diameter more than the stent to be implanted.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Under-age patient
- •Patient of age, but under legal guardianship or care
- •Potentially pregnant women
- •Patients do not understand the French language
- •Asymptomatic lesion
- •Acute ischemia or acute thrombosis
- •Lesion already treated
- •No-atherosclerotic disease
- •hemostasis disorder
- •severe comorbidity with life expectancy less than 2 years
- •contraindication of antiplatelet (dual antiplatelet therapy required during at least 2 month post-intervention)
- •patient participating in a clinical trial likely to interfer
- •Comorbidity or other, according investigator, that may interferer with the conduct of the study
- •lesion near to an aneurysm
- •Patient follow-up impossible
- •Patient refuse to participate
Outcomes
Primary Outcomes
Number of patient with improvement of at least one category of Rutherford classification
Time Frame: 12 months
To evaluate the sustained clinical effectiveness of the SuperA stent (Abbott) at 12-month for TASC C and D atherosclerotic femoropopliteal lesions in patients with symptomatic primary artery disease (PAD) (RUTHERFORD 2 to 6). Improvement of at least 1 category of Rutherford classification for claudicants. Healing of a trophic disorder and disappearance of resting pain for patient with critical ischemia
Secondary Outcomes
- number of patient presenting a major adverse cardiovascular event(24 months)
- variation of the ABI (Ankle systolic pression (mmHg) / brachial systolique pression (mmHg) index) before and after surgery(24 months)
- number of patient presenting a major adverse limb event(24 months)
- Number of patient with improvement of at least one category of Rutherford classification(24 months)
- rate of Target Lesion Revascularization (TLR)(24 months)
- rate of Target Extremity Revascularization (TER)(24 months)
- number of patient with sustained permeability without restenosis > 30% in lack of reintervention(24 months)
- number of patient with sustained permeability without restenosis > 30% after reintervention(24 months)
- limb salvage rate measurement(24 months)
- quality of life in patients treated with the SuperA stent(24months)
- Assessment of vessel calcification rate(24months)
- restenosis measurement(24 months)
- thrombosis measurement(24 months)
- stenting length measurement(24 months)
- stent fracture measurement(24 months)
- Assessment of elongation rate of SuperA(24months)
- Assessment of stent diameter(24months)
- Number of patient presenting cardiovascular comorbidity(24months)
- Number of patient presenting a renal dysfunction (creatinine clearance < 60 mL/min and/or dialysis)(24months)
- Number of patient treated with anti-platelet therapy(24months)