Stella Supera Siberia

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

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

Study Overview

• Status: Unknown
• Conditions: Peripheral Arterial Disease; Atherosclerosis; Superficial Femoral Artery Occlusion
• Intervention / Treatment: Device: Endovascular treatment for PAD

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexander A Gostev; Phone Number: +73833476066; Email: a_gostev@meshalkin.ru

Study Locations

• Russian Federation
  • Novosibirskaya Obl
    • Novosibirsk, Novosibirskaya Obl, Russian Federation, 630005
      • Recruiting
      • Alexander A Gostev
      • Contact: Alexander A Gostev; Phone Number: 5677766; Email: a_gostev@meshalkin.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Endovascular treatment for PAD; Single group study (1 arm)	Device: Endovascular treatment for PAD; Long femoropopliteal stenting with SuperA devices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Meshalkin Research Institute of Pathology of Circulation
• Collaborators: Abbott

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2019
• Primary Completion (Anticipated): May 13, 2022
• Study Completion (Anticipated): May 13, 2022

Study Registration Dates

• First Submitted: April 24, 2019
• First Submitted That Met QC Criteria: May 14, 2019
• First Posted (Actual): May 15, 2019

Study Record Updates

• Last Update Posted (Actual): May 29, 2020
• Last Update Submitted That Met QC Criteria: May 27, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Atherosclerosis
• Other Study ID Numbers: NSK001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No