Stella Supera Siberia

NCT03951727 | Unknown DMC

• 1 other identifier: NSK001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Atherosclerosis; Peripheral Arterial Disease; Superficial Femoral Artery Occlusion

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Changes in chronic lower limb ischemia at 24 months follow-up

  24 months

• Major adverse cardiovascular events

  24 months

• Major adverse limb events

  24 months

• Limb salvage rate

  24 months

• Changes in ankle-brachial index

  24 months

Study Arms (1)

Endovascular treatment for PAD

OTHER

Single group study (1 arm)

Device: Endovascular treatment for PAD

Interventions

Endovascular treatment for PAD DEVICE

Long femoropopliteal stenting with SuperA devices

Endovascular treatment for PAD

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Meshalkin Research Institute of Pathology of Circulation: lead
• Abbott: collaborator

Study Sites (1)

Alexander A Gostev

Novosibirsk, Novosibirskaya Obl, 630005, Russia

RECRUITING

MeSH Terms

Conditions

Atherosclerosis; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Central Study Contacts

Alexander A Gostev

CONTACT

+73833476066; a_gostev@meshalkin.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: May 15, 2019
• Study Start: May 13, 2019
• Primary Completion: May 13, 2022
• Study Completion: May 13, 2022
• Last Updated: May 29, 2020

Record last verified: 2020-05

Locations

RU (1)