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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endovascular treatment for PAD | Other | Single group study (1 arm) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular treatment for PAD | Device | Long femoropopliteal stenting with SuperA devices |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in chronic lower limb ischemia at 12 months follow-up | 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in chronic lower limb ischemia at 24 months follow-up | 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 | 24 months |
| Major adverse cardiovascular events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexander A Gostev | Contact | +73833476066 | a_gostev@meshalkin.ru |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexander A Gostev | Recruiting | Novosibirsk | Novosibirskaya Obl | 630005 | Russia |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Number of cases of MACE at 24 months follow-up |
| 24 months |
| Major adverse limb events | Number of cases of MALE at 24 months follow-up | 24 months |
| Limb salvage rate | Number of cases of limb salvage at 24 months follow-up | 24 months |
| Changes in ankle-brachial index | Changes in mean of ankle-brachial index after procedure at 24 months follow-up | 24 months |
| Primary patency | Primary patency rate at 24 months follow-up | 24 months |
| Secondary patency | Secondary patency rate at 24 months follow-up | 24 months |
| Restenosis rate | Number of cases of significant restenosis (more, than 50%) in stenting arterial segment | 24 months |
| Thrombosis rate | Number of cases of thrombosis in stenting arterial segment | 24 months |
| Changes in the patients quality of life | Changes in mean of EQ5D-3L questionnaire units after procedure | 1, 12, 24 months |
| D016491 |
| Peripheral Vascular Diseases |