Stella Supera Siberia
- Conditions
- AtherosclerosisPeripheral Arterial DiseaseSuperficial Femoral Artery Occlusion
- Interventions
- Device: Endovascular treatment for PAD
- Registration Number
- NCT03951727
- Lead Sponsor
- Meshalkin Research Institute of Pathology of Circulation
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- 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
- 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 interfere with the conduct of the study
- lesion near to an aneurysm
- Patient follow-up impossible
- Patient refuse to participate
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Endovascular treatment for PAD Endovascular treatment for PAD Single group study (1 arm)
- Primary Outcome Measures
Name Time Method Changes in chronic lower limb ischemia at 12 months follow-up 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 Outcome Measures
Name Time Method Major adverse limb events 24 months Number of cases of MALE at 24 months follow-up
Limb salvage rate 24 months Number of cases of limb salvage at 24 months follow-up
Changes in ankle-brachial index 24 months Changes in mean of ankle-brachial index after procedure at 24 months follow-up
Major adverse cardiovascular events 24 months Number of cases of MACE at 24 months follow-up
Primary patency 24 months Primary patency rate at 24 months follow-up
Secondary patency 24 months Secondary patency rate at 24 months follow-up
Thrombosis rate 24 months Number of cases of thrombosis in stenting arterial segment
Changes in chronic lower limb ischemia at 24 months follow-up 24 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 ischemiaChanges in the patients quality of life 1, 12, 24 months Changes in mean of EQ5D-3L questionnaire units after procedure
Restenosis rate 24 months Number of cases of significant restenosis (more, than 50%) in stenting arterial segment
Trial Locations
- Locations (1)
Alexander A Gostev
🇷🇺Novosibirsk, Novosibirskaya Obl, Russian Federation