Clinical trial NCT03951727: Stella Supera Siberia
Official title: Long Superficial Femoral Artery Stenting With SuperA Interwoven Nitinol Stents - Siberia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atherosclerosis
Peripheral Arterial Disease
Superficial Femoral Artery Occlusion
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
Collaborators: name: Abbott
First posted: 2019-05-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Changes in chronic lower limb ischemia at 12 months follow-up
timeFrame: 12 months
Secondary outcomes:
measure: Changes in chronic lower limb ischemia at 24 months follow-up
timeFrame: 24 months
measure: Major adverse cardiovascular events
timeFrame: 24 months
measure: Major adverse limb events
timeFrame: 24 months
measure: Limb salvage rate
timeFrame: 24 months
measure: Changes in ankle-brachial index
timeFrame: 24 months
measure: Primary patency
timeFrame: 24 months
measure: Secondary patency
timeFrame: 24 months
measure: Restenosis rate
timeFrame: 24 months
measure: Thrombosis rate
timeFrame: 24 months
measure: Changes in the patients quality of life
timeFrame: 1, 12, 24 months
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Alexander A Gostev
state: Novosibirskaya Obl
Study officials:
References: