Stella Supera Siberia

Atherosclerosis Clinical Trial

Official title:

Long Superficial Femoral Artery Stenting With SuperA Interwoven Nitinol Stents - Siberia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03951727
• Other study ID #: NSK001
• Status: Recruiting
• Phase: N/A
• Start date: May 13, 2019
• Est. completion date: May 13, 2022

Study information

• Verified date: May 2020
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: Alexander A Gostev
• Phone: +73833476066
• Email: a_gostev[@]meshalkin.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 13, 2022
• Est. primary completion date: May 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Superficial Femoral Artery Occlusion

Intervention

Device:
• Endovascular treatment for PAD
Long femoropopliteal stenting with SuperA devices

Locations

Country	Name	City	State
Russian Federation	Alexander A Gostev	Novosibirsk	Novosibirskaya Obl

Sponsors (2)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation	Abbott

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Major adverse cardiovascular events	Number of cases of MACE at 24 months follow-up	24 months
Secondary	Major adverse limb events	Number of cases of MALE at 24 months follow-up	24 months
Secondary	Limb salvage rate	Number of cases of limb salvage at 24 months follow-up	24 months
Secondary	Changes in ankle-brachial index	Changes in mean of ankle-brachial index after procedure at 24 months follow-up	24 months
Secondary	Primary patency	Primary patency rate at 24 months follow-up	24 months
Secondary	Secondary patency	Secondary patency rate at 24 months follow-up	24 months
Secondary	Restenosis rate	Number of cases of significant restenosis (more, than 50%) in stenting arterial segment	24 months
Secondary	Thrombosis rate	Number of cases of thrombosis in stenting arterial segment	24 months
Secondary	Changes in the patients quality of life	Changes in mean of EQ5D-3L questionnaire units after procedure	1, 12, 24 months