Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT03951727
Status:
UNKNOWN
Last Update Posted:
2020-05-29
First Post:
2019-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stella Supera Siberia
Sponsor:
Meshalkin Research Institute of Pathology of Circulation
Organization:
Study Overview
Official Title:
Long Superficial Femoral Artery Stenting With SuperA Interwoven Nitinol Stents - Siberia
Status:
UNKNOWN
Status Verified Date:
2020-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: