Stella Supera Siberia
Primary Purpose
Atherosclerosis, Peripheral Arterial Disease, Superficial Femoral Artery Occlusion
Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Endovascular treatment for PAD
Sponsored by
About this trial
This is an interventional treatment trial for Atherosclerosis
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
Sites / Locations
- Alexander A GostevRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Endovascular treatment for PAD
Arm Description
Single group study (1 arm)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Major adverse cardiovascular events
Number of cases of MACE at 24 months follow-up
Major adverse limb events
Number of cases of MALE at 24 months follow-up
Limb salvage rate
Number of cases of limb salvage at 24 months follow-up
Changes in ankle-brachial index
Changes in mean of ankle-brachial index after procedure at 24 months follow-up
Primary patency
Primary patency rate at 24 months follow-up
Secondary patency
Secondary patency rate at 24 months follow-up
Restenosis rate
Number of cases of significant restenosis (more, than 50%) in stenting arterial segment
Thrombosis rate
Number of cases of thrombosis in stenting arterial segment
Changes in the patients quality of life
Changes in mean of EQ5D-3L questionnaire units after procedure
Full Information
NCT ID
NCT03951727
First Posted
April 24, 2019
Last Updated
May 27, 2020
Sponsor
Meshalkin Research Institute of Pathology of Circulation
Collaborators
Abbott
1. Study Identification
Unique Protocol Identification Number
NCT03951727
Brief Title
Stella Supera Siberia
Official Title
Long Superficial Femoral Artery Stenting With SuperA Interwoven Nitinol Stents - Siberia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 13, 2019 (Actual)
Primary Completion Date
May 13, 2022 (Anticipated)
Study Completion Date
May 13, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation
Collaborators
Abbott
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis, Peripheral Arterial Disease, Superficial Femoral Artery Occlusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Endovascular treatment for PAD
Arm Type
Other
Arm Description
Single group study (1 arm)
Intervention Type
Device
Intervention Name(s)
Endovascular treatment for PAD
Intervention Description
Long femoropopliteal stenting with SuperA devices
Primary Outcome Measure Information:
Title
Changes in chronic lower limb ischemia at 12 months follow-up
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Changes in chronic lower limb ischemia at 24 months follow-up
Description
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
Time Frame
24 months
Title
Major adverse cardiovascular events
Description
Number of cases of MACE at 24 months follow-up
Time Frame
24 months
Title
Major adverse limb events
Description
Number of cases of MALE at 24 months follow-up
Time Frame
24 months
Title
Limb salvage rate
Description
Number of cases of limb salvage at 24 months follow-up
Time Frame
24 months
Title
Changes in ankle-brachial index
Description
Changes in mean of ankle-brachial index after procedure at 24 months follow-up
Time Frame
24 months
Title
Primary patency
Description
Primary patency rate at 24 months follow-up
Time Frame
24 months
Title
Secondary patency
Description
Secondary patency rate at 24 months follow-up
Time Frame
24 months
Title
Restenosis rate
Description
Number of cases of significant restenosis (more, than 50%) in stenting arterial segment
Time Frame
24 months
Title
Thrombosis rate
Description
Number of cases of thrombosis in stenting arterial segment
Time Frame
24 months
Title
Changes in the patients quality of life
Description
Changes in mean of EQ5D-3L questionnaire units after procedure
Time Frame
1, 12, 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander A Gostev
Phone
+73833476066
Email
a_gostev@meshalkin.ru
Facility Information:
Facility Name
Alexander A Gostev
City
Novosibirsk
State/Province
Novosibirskaya Obl
ZIP/Postal Code
630005
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander A Gostev
Phone
5677766
Email
a_gostev@meshalkin.ru
12. IPD Sharing Statement
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Stella Supera Siberia
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