Stella Supera Siberia

NCT ID: NCT03951727

Last Updated: 2020-05-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-13
• Study Completion Date: 2022-05-13

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.

Conditions

Atherosclerosis; Peripheral Arterial Disease; Superficial Femoral Artery Occlusion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Endovascular treatment for PAD

Single group study (1 arm)

Group Type: OTHER

Endovascular treatment for PAD

Intervention Type: DEVICE

Long femoropopliteal stenting with SuperA devices

Interventions

Endovascular treatment for PAD

Long femoropopliteal stenting with SuperA devices

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: collaborator

Meshalkin Research Institute of Pathology of Circulation

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Alexander A Gostev

Novosibirsk, Novosibirskaya Obl, Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Alexander A Gostev

Role: CONTACT

a_gostev@meshalkin.ru

+73833476066

Facility Contacts

Alexander A Gostev

Role: primary

a_gostev@meshalkin.ru

5677766

Other Identifiers

NSK001

Identifier Type: -

Identifier Source: org_study_id