Long Superficial Femoral Artery Stenting With SuperA Interwoven Nitinol Stents - Siberia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atherosclerosis
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Changes in chronic lower limb ischemia at 12 months follow-up
- Last Updated
- 5 years ago
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 criterias, the possible influence of calcifications and the quality of life of patients
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 : 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. A control arteriography will be done before the implantation of the stent and at the end of the intervention to assess the success of the procedure. If needed, endovascular treatment could be realized on the inflow or outflow in the same time. Patient follow-up : Patient follow-up is performed at 1, 6, 12 and 24 months. Follow-up will systematically include a clinical evaluation and a duplex scan with the ankle brachial index (ABI). The x-rays and the quality of life questionnaire will be done at 1, 12 and 24 months. All clinical surveillance events, complications and re-hospitalizations will be collected.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Symptomatic PAD, Rutherford 2 to 6
- •Atherosclerotic femoropopliteal lesion TASC C or D (on CT scan or arteriography)
- •De novo femoropopliteal lesion
- •Patient informed of the study and oral authorization collected
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
Outcomes
Primary Outcomes
Changes in chronic lower limb ischemia at 12 months follow-up
Time Frame: 12 months
Number of cases of 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
- Major adverse limb events(24 months)
- Limb salvage rate(24 months)
- Changes in ankle-brachial index(24 months)
- Major adverse cardiovascular events(24 months)
- Primary patency(24 months)
- Secondary patency(24 months)
- Thrombosis rate(24 months)
- Changes in chronic lower limb ischemia at 24 months follow-up(24 months)
- Changes in the patients quality of life(1, 12, 24 months)
- Restenosis rate(24 months)