AtherosclerosisNCT03951727
Stella Supera Siberia
A study testing Endovascular treatment for PAD in people with Atherosclerosis and Peripheral Arterial Disease, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atherosclerosis, Peripheral Arterial Disease, Superficial Femoral Artery Occlusion
- What is being tested?
- Endovascular treatment for PAD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteRussia
- Study dates
- 13 May 2019to 13 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Alexander A Gostev
Novosibirsk, Novosibirskaya Obl, 630005
Alexander A Gostev, 5677766, a_gostev@meshalkin.ru
About this study
Official title: 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
Read the 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.
- Being tested
- Endovascular treatment for PAD
- Medical subject headings
- Atherosclerosis, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular treatment for PADDevice
Long femoropopliteal stenting with SuperA devices
| Study group | Role | What they receive |
|---|---|---|
| Endovascular treatment for PAD | Other | Single group study (1 arm) Receives: Device: Endovascular treatment for PAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (10)
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
Measured: 24 months
Major adverse cardiovascular events
Number of cases of MACE at 24 months follow-up
Measured: 24 months
Major adverse limb events
Number of cases of MALE at 24 months follow-up
Measured: 24 months
Limb salvage rate
Number of cases of limb salvage at 24 months follow-up
Measured: 24 months
Changes in ankle-brachial index
Changes in mean of ankle-brachial index after procedure at 24 months follow-up
Measured: 24 months
Primary patency
Primary patency rate at 24 months follow-up
Measured: 24 months
Secondary patency
Secondary patency rate at 24 months follow-up
Measured: 24 months
Restenosis rate
Number of cases of significant restenosis (more, than 50%) in stenting arterial segment
Measured: 24 months
Thrombosis rate
Number of cases of thrombosis in stenting arterial segment
Measured: 24 months
Changes in the patients quality of life
Changes in mean of EQ5D-3L questionnaire units after procedure
Measured: 1, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start13 May 2019
- Primary completion13 May 2022 (estimated)
- Study completion13 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Collaborators
- Abbott
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03951727
- Sponsor's protocol ID
- NSK001
- Status last verified
- May 2020
- First submitted
- 24 Apr 2019
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Superficial Femoral Artery Stenting With SuperA Interwoven Nitinol Stents - Siberia
- ClinicalTrials.gov ID
- NCT03951727
- Acronym / sponsor ID
- NSK001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Collaborators
- Abbott
- Study start
- 13 May 2019 (actual)
- Primary completion
- 13 May 2022 (estimated)
- Study completion
- 13 May 2022 (estimated)
- First posted
- 15 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endovascular treatment for PAD | Other | Device: Endovascular treatment for PADSingle group study (1 arm) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- Under-age patient
- Patient of age, but under legal guardianship or care
- Potentially pregnant women
- Patients do not understand the French language
- Asymptomatic lesion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular treatment for PADLong femoropopliteal stenting with SuperA devices | Device | Endovascular treatment for PAD |
Primary outcome
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
10 secondary outcomes
Changes in chronic lower limb ischemia at 24 months follow-up
Time frame: 24 months
Major adverse cardiovascular events
Time frame: 24 months
Major adverse limb events
Time frame: 24 months
Limb salvage rate
Time frame: 24 months
Changes in ankle-brachial index
Time frame: 24 months
Primary patency
Time frame: 24 months
Secondary patency
Time frame: 24 months
Restenosis rate
Time frame: 24 months
Thrombosis rate
Time frame: 24 months
Changes in the patients quality of life
Time frame: 1, 12, 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular treatment for PAD in people with Atherosclerosis and Peripheral Arterial Disease, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander A Gostev (+73833476066, a_gostev@meshalkin.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in chronic lower limb ischemia at 12 months follow-up (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2020.