Stella Supera Siberia

• ClinicalTrials.gov Identifier: NCT03951727
• Recruitment Status: Unknown
• First Posted: May 15, 2019
• Last Update Posted: May 29, 2020
• Sponsor: Meshalkin Research Institute of Pathology of Circulation
• Collaborator: Abbott
• Information provided by (Responsible Party): Meshalkin Research Institute of Pathology of Circulation

Tracking Information

• First Submitted Date: April 24, 2019
• First Posted Date: May 15, 2019
• Last Update Posted Date: May 29, 2020
• Actual Study Start Date: May 13, 2019
• Estimated Primary Completion Date: May 13, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 14, 2019)

Changes in chronic lower limb ischemia at 12 months follow-up [ Time Frame: 12 months ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 14, 2019)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Stella Supera Siberia
• Official Title: Long Superficial Femoral Artery Stenting With SuperA Interwoven Nitinol Stents - Siberia

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Atherosclerosis
• Peripheral Arterial Disease
• Superficial Femoral Artery Occlusion

Intervention

Device: Endovascular treatment for PAD

Long femoropopliteal stenting with SuperA devices

Study Arms

Endovascular treatment for PAD

Single group study (1 arm)

Intervention: Device: Endovascular treatment for PAD

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: May 14, 2019): 50
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 13, 2022
• Estimated Primary Completion Date: May 13, 2022 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Russian Federation

Administrative Information

• NCT Number: NCT03951727
• Other Study ID Numbers: NSK001
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Meshalkin Research Institute of Pathology of Circulation
• Original Responsible Party: Same as current
• Current Study Sponsor: Meshalkin Research Institute of Pathology of Circulation
• Original Study Sponsor: Same as current
• Collaborators: Abbott
• Investigators: Not Provided
• PRS Account: Meshalkin Research Institute of Pathology of Circulation
• Verification Date: May 2020