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
Condition or disease | Intervention/treatment | Phase |
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Atherosclerosis Peripheral Arterial Disease Superficial Femoral Artery Occlusion | Device: Endovascular treatment for PAD | Not Applicable |
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 (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Long Superficial Femoral Artery Stenting With SuperA Interwoven Nitinol Stents - Siberia |
Actual Study Start Date : | May 13, 2019 |
Estimated Primary Completion Date : | May 13, 2022 |
Estimated Study Completion Date : | May 13, 2022 |
Arm | Intervention/treatment |
---|---|
Endovascular treatment for PAD
Single group study (1 arm)
|
Device: Endovascular treatment for PAD
Long femoropopliteal stenting with SuperA devices
|
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
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
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Alexander A Gostev | +73833476066 | a_gostev@meshalkin.ru |
Russian Federation | |
Alexander A Gostev | Recruiting |
Novosibirsk, Novosibirskaya Obl, Russian Federation, 630005 | |
Contact: Alexander A Gostev 5677766 a_gostev@meshalkin.ru |
Tracking Information | |||||
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First Submitted Date ICMJE | April 24, 2019 | ||||
First Posted Date ICMJE | May 15, 2019 | ||||
Last Update Posted Date | May 29, 2020 | ||||
Actual Study Start Date ICMJE | May 13, 2019 | ||||
Estimated Primary Completion Date | May 13, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Stella Supera Siberia | ||||
Official Title ICMJE | 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 |
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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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
|
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Intervention ICMJE | Device: Endovascular treatment for PAD
Long femoropopliteal stenting with SuperA devices
|
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Study Arms ICMJE | Endovascular treatment for PAD
Single group study (1 arm)
Intervention: Device: Endovascular treatment for PAD
|
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
50 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | May 13, 2022 | ||||
Estimated Primary Completion Date | May 13, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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Sex/Gender ICMJE |
|
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Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Russian Federation | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03951727 | ||||
Other Study ID Numbers ICMJE | NSK001 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Meshalkin Research Institute of Pathology of Circulation | ||||
Study Sponsor ICMJE | Meshalkin Research Institute of Pathology of Circulation | ||||
Collaborators ICMJE | Abbott | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Meshalkin Research Institute of Pathology of Circulation | ||||
Verification Date | May 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |