Stella Supera Siberia

Meshalkin Research Institute of Pathology of Circulation

Status

Unknown

Conditions

Superficial Femoral Artery Occlusion

Peripheral Arterial Disease

Atherosclerosis

Treatments

Device: Endovascular treatment for PAD

Study type

Interventional

Funder types

NETWORK

Industry

Identifiers

NCT03951727

NSK001

Details and patient eligibility

About

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

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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
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