Superficial Femoral Artery StenosisFMJSFANCT04461496
Full Metall Jacket Multilevel Segment
A study testing Hybrid revascularization and Full metall Jacket in people with Superficial Femoral Artery Stenosis and Iliac Artery Occlusion, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
Hypothesis: "Total" endovascular revascularization of a multistory lesion of the iliac-femoral-popliteal segment is safer and a better quality of life is achieved in comparison with hybrid intervention. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Superficial Femoral Artery Stenosis, Iliac Artery Occlusion
- What is being tested?
- Hybrid revascularization and Full metall Jacket
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- 30 Jun 2020to 5 Jun 2025
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with multisegment lesions of the iliac-femoral-popliteal segment, with the distal border of the lesion above the slit of the knee joint.
- chronic ischemia 3-6 (according to Rutherford),
- the satisfactory direction of the outflow.
- Patients who gave consent to participate in this study
Who cannot join
- Chronic occlusion of the SFA at least 2cm
- Heavy calcification of SFA • Infection in the area of the access artery
- Expressed, more than 50% stenotic lesions of the infrarenal aorta
- Prolonged loss (TASC D) iliac artery on the side of revascularization
- aneurysmal widening of the infrarenal aorta and iliac arteries
- Hemodynamically significant lesions DFA
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- Chronic heart failure III-IV functional class NYHA classification;
- decompensated Chronic "pulmonary" heart; • Severe hepatic or renal insufficiency (bilirubin >35 mmol/l, glomerular filtration rate <60 ml/min);
- Polyvalent drug Allergy;
- Malignant cancer in the terminal stage with a projected life span of 6 months;
- Acute stroke;
- a Pronounced calcification of the arteries of the lower limbs;
- Patients with significant lesions of the common femoral artery
- the Refusal of a patient to participate or continue to participate in the study.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Meshalkin Research Institute of Pathology of Circulation
Novosibirsk, Novosibirskaya Obl, 630055
Andrey A Karpenko, PHD, 89134504100, a_karpenko@meshalkin.ru
About this study
Official title: The Pilot Clinical Trial Comparing the Efficacy of Single-stage Multilevel Revascularization of the Iliac-femoral-popliteal Segment Using the FULL METALL JACKET Technology in Comparison With the Hybrid Revascularization Procedure
Hypothesis: "Total" endovascular revascularization of a multistory lesion of the iliac-femoral-popliteal segment is safer and a better quality of life is achieved in comparison with hybrid intervention.
The lack of damage to the skin avoids complications in the postoperative and remote periods of observation, thereby improving the quality of life
Read the detailed description
Mortality from cardiovascular disease occupies a leading position worldwide. Patients with atherosclerotic lesions of the peripheral arteries account for 20% of the total number of patients with cardiovascular diseases. Special attention should be paid to patients with multilevel lesions artery since the maximum reduction in blood flow leads to the development of critical limb ischemia (CLI) and a high risk of limb loss. Almost 25% of patients with CLI require multistory revascularization of the arteries of the lower extremities. In this group of patients, proximal revascularization of the only iliac segment is usually the initial approach, but in some cases leads to disappointing relief of symptoms due to concomitant severe lesions of the infra-anginal arteries. Whereas the combined implementation of femoral-popliteal bypass surgery or endovascular revascularization of SFA can increase the likelihood of ulcer healing and avoid multi-stage surgical interventions. In turn, an adequate inflow to the revascularized segment is necessary for its long-term functioning.
Femoral-popliteal bypass surgery is still the procedure of choice for long occlusions of the superficial femoral artery TASC C, D. The "total" endovascular correction (full metal jacket) may become an alternative to hybrid technology since allows for less traumatic and fully revascularization of the wall occlusal lesions of SFA. The salvation of the limb and the achievement of compensation for the clinic of chronic lower limb ischemia in patients with multi-vessel atherosclerotic lesions of the arteries of the lower extremities is possible using both hybrid procedures and endovascular reconstruction. The main goal of stenting the iliac arteries during hybrid procedures is not only to restore blood flow in the common and deep femoral arteries but also to support the long-term functioning of the femoral-popliteal shunt or stent in SFA.
Similar analogues of the comparative study of the two methods of revascularization in the world literature the investigators have not seen.
In the first group, stenting of the iliac artery under x-ray control with the bypass of the femoral-popliteal segment above the gap of the knee joint is performed. The first stage is performed femoral-popliteal bypass surgery above the fissure of the knee joint according to conventional technology. Conduit is at the discretion of the operating surgeon. Intraoperatively bolus is administered heparin 5000 IU. The second step is the puncture of the selected CFA with a retrograde installation of the introducer sheath. The iliac segment is recanalized with angioplasty and stent implantation in the affected area. In the postoperative period, clexane is administered at a prophylactic dosage of 3 days and cardiomagnyl at a dosage of 75 mg per day. Next, the patient takes dual antiplatelet therapy cardiomagnyl 75 mg + clopidogrel 75 mg for 6 months.
In the second group, stenting of the iliac artery and recanalization SFA with angioplasty and stenting under X-ray control is performed. The first step is the puncture contralateral CFA with a retrograde installation of the introducer. Intraoperatively bolus is administered heparin 5000 IU. A conductor is placed in the contralateral iliac artery along the conductor. A stent is implanted in the iliac artery lesion. The second stage is the recanalization of the femoral-popliteal segment with angioplasty and stent implantation in the affected area. In the postoperative period, a loading dose of clopidogrel 300 mg + cardiomagnyl 75 mg is taken. Next, the patient takes dual antiplatelet therapy cardiomagnyl 75 mg + clopidogrel 75 mg for 6 months.
Statistical analysis: Data processing and comparison of variables will be carried out by appropriate statistical methods with a preliminary check for compliance of the sign variability with the normal distribution, which is evaluated by the Kolmogorov-Smirnov criterion. Under the condition of the normal distribution, Student's criterion is used. A comparative assessment of qualitative characteristics is carried out using the χ2 criterion. The dynamics of the indicators in the group will be determined by the pairwise coupled option using the Student criterion with a normal distribution of indicators and using the Wilcoxon criterion - with a mismatch with the normal distribution. Comparison according to qualitative characteristics (gender, degree of ischemia, and others) will be carried out using the criteria of Pearson (Pearson) and Fisher (Fisher). In all cases, a 95% significance level is used.
- Being tested
- Hybrid revascularization, Full metall Jacket
- Keywords
- hybrid revascularization, atherosclerosis
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid revascularizationProcedure or surgery
The first stage is performed femoral-popliteal bypass surgery above the fissure of the knee joint according to conventional technology. Conduit is at the discretion of the operating surgeon. Intraoperatively bolus is administered sol. heparin 5000 IU. The second step is the puncture of the selected CFA with a retrograde installation of the introducer sheath. The iliac segment is recanalized with angioplasty and stent implantation in the affected area
Full metall JacketProcedure or surgery
The first step is the puncture contralateral CFA with a retrograde installation of the introducer. Intraoperatively bolus is administered sol. heparin 5000 IU. A conductor is placed in the contralateral iliac artery along the conductor. A stent is implanted in the iliac artery lesion. The second stage is the recanalization of the femoral-popliteal segment with angioplasty and stent implantation in the affected area.
| Study group | Role | What they receive |
|---|---|---|
| Hybrid revascularization | Active comparator | 50 hybrid procedure Receives: Procedure: Hybrid revascularization |
| Full metall jacket | Experimental | 50 total endovascular interventions Receives: Procedure: Full metall Jacket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the procedure
freedom from thrombosis was defined as the absence of occlusion by duplex ultrasonography or CT angiography of the treated segment
Measured: 24 months
Safety of the procedure
bleeding according to blood loss volume (millilitres) 1. intraoperative blood loss volume; 2.Postoperative blood loss volume by duplex ultrasonography and drainage losses
Measured: 30 days
Safety of the procedure
major adverse limb events according to clinical evaluation
Measured: 24 months
Secondary outcomes (5)
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
Changes in the patients quality of life: questionnaire
improving the quality of life in accordance with the questionnaire "The Short Form-36" for 24 months. The indicators of each scale are designed in such a way that the higher the value of the indicator (from 0 to 100), the better the score on the selected scale
Measured: 24 months
Success of the procedure
the number of successful attempts
Measured: 1 month
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start30 Jun 2020
- Primary completion5 Jun 2025 (estimated)
- Study completion5 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superficial Femoral Artery StenosisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04461496
- Sponsor's protocol ID
- FMJ
- Acronym
- FMJSFA
- Status last verified
- Jun 2020
- First submitted
- 29 Jun 2020
- Last updated
- 13 Jul 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 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pilot Clinical Trial Comparing the Efficacy of Single-stage Multilevel Revascularization of the Iliac-femoral-popliteal Segment Using the FULL METALL JACKET Technology in Comparison With the Hybrid Revascularization Procedure
- ClinicalTrials.gov ID
- NCT04461496
- Acronym / sponsor ID
- FMJSFA / FMJ
- Keywords
- hybrid revascularization, atherosclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 5 Jun 2025 (estimated)
- Study completion
- 5 Jun 2025 (estimated)
- First posted
- 8 Jul 2020 (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.
Hypothesis: "Total" endovascular revascularization of a multistory lesion of the iliac-femoral-popliteal segment is safer and a better quality of life is achieved in comparison with hybrid intervention.
The lack of damage to the skin avoids complications in the postoperative and remote periods of observation, thereby improving the quality of life
Detailed description
Mortality from cardiovascular disease occupies a leading position worldwide. Patients with atherosclerotic lesions of the peripheral arteries account for 20% of the total number of patients with cardiovascular diseases. Special attention should be paid to patients with multilevel lesions artery since the maximum reduction in blood flow leads to the development of critical limb ischemia (CLI) and a high risk of limb loss. Almost 25% of patients with CLI require multistory revascularization of the arteries of the lower extremities. In this group of patients, proximal revascularization of the only iliac segment is usually the initial approach, but in some cases leads to disappointing relief of symptoms due to concomitant severe lesions of the infra-anginal arteries. Whereas the combined implementation of femoral-popliteal bypass surgery or endovascular revascularization of SFA can increase the likelihood of ulcer healing and avoid multi-stage surgical interventions. In turn, an adequate inflow to the revascularized segment is necessary for its long-term functioning.
Femoral-popliteal bypass surgery is still the procedure of choice for long occlusions of the superficial femoral artery TASC C, D. The "total" endovascular correction (full metal jacket) may become an alternative to hybrid technology since allows for less traumatic and fully revascularization of the wall occlusal lesions of SFA. The salvation of the limb and the achievement of compensation for the clinic of chronic lower limb ischemia in patients with multi-vessel atherosclerotic lesions of the arteries of the lower extremities is possible using both hybrid procedures and endovascular reconstruction. The main goal of stenting the iliac arteries during hybrid procedures is not only to restore blood flow in the common and deep femoral arteries but also to support the long-term functioning of the femoral-popliteal shunt or stent in SFA.
Similar analogues of the comparative study of the two methods of revascularization in the world literature the investigators have not seen.
In the first group, stenting of the iliac artery under x-ray control with the bypass of the femoral-popliteal segment above the gap of the knee joint is performed. The first stage is performed femoral-popliteal bypass surgery above the fissure of the knee joint according to conventional technology. Conduit is at the discretion of the operating surgeon. Intraoperatively bolus is administered heparin 5000 IU. The second step is the puncture of the selected CFA with a retrograde installation of the introducer sheath. The iliac segment is recanalized with angioplasty and stent implantation in the affected area. In the postoperative period, clexane is administered at a prophylactic dosage of 3 days and cardiomagnyl at a dosage of 75 mg per day. Next, the patient takes dual antiplatelet therapy cardiomagnyl 75 mg + clopidogrel 75 mg for 6 months.
In the second group, stenting of the iliac artery and recanalization SFA with angioplasty and stenting under X-ray control is performed. The first step is the puncture contralateral CFA with a retrograde installation of the introducer. Intraoperatively bolus is administered heparin 5000 IU. A conductor is placed in the contralateral iliac artery along the conductor. A stent is implanted in the iliac artery lesion. The second stage is the recanalization of the femoral-popliteal segment with angioplasty and stent implantation in the affected area. In the postoperative period, a loading dose of clopidogrel 300 mg + cardiomagnyl 75 mg is taken. Next, the patient takes dual antiplatelet therapy cardiomagnyl 75 mg + clopidogrel 75 mg for 6 months.
Statistical analysis: Data processing and comparison of variables will be carried out by appropriate statistical methods with a preliminary check for compliance of the sign variability with the normal distribution, which is evaluated by the Kolmogorov-Smirnov criterion. Under the condition of the normal distribution, Student's criterion is used. A comparative assessment of qualitative characteristics is carried out using the χ2 criterion. The dynamics of the indicators in the group will be determined by the pairwise coupled option using the Student criterion with a normal distribution of indicators and using the Wilcoxon criterion - with a mismatch with the normal distribution. Comparison according to qualitative characteristics (gender, degree of ischemia, and others) will be carried out using the criteria of Pearson (Pearson) and Fisher (Fisher). In all cases, a 95% significance level is used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hybrid revascularization | Active comparator | Procedure: Hybrid revascularization50 hybrid procedure |
| Full metall jacket | Experimental | Procedure: Full metall Jacket50 total endovascular interventions |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with multisegment lesions of the iliac-femoral-popliteal segment, with the distal border of the lesion above the slit of the knee joint.
- chronic ischemia 3-6 (according to Rutherford),
- the satisfactory direction of the outflow.
- Patients who gave consent to participate in this study
Key exclusion criteria (14 listed)
- Chronic occlusion of the SFA at least 2cm
- Heavy calcification of SFA • Infection in the area of the access artery
- Expressed, more than 50% stenotic lesions of the infrarenal aorta
- Prolonged loss (TASC D) iliac artery on the side of revascularization
- aneurysmal widening of the infrarenal aorta and iliac arteries
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 |
|---|---|---|
| Hybrid revascularizationThe first stage is performed femoral-popliteal bypass surgery above the fissure of the knee joint according to conventional technology. Conduit is at the discretion of the operating surgeon. Intraoperatively bolus is administered sol. heparin 5000 IU. The second step is the puncture of the selected CFA with a retrograde installation of the introducer sheath. The iliac segment is recanalized with angioplasty and stent implantation in the affected area | Procedure or surgery | Hybrid revascularization |
| Full metall JacketThe first step is the puncture contralateral CFA with a retrograde installation of the introducer. Intraoperatively bolus is administered sol. heparin 5000 IU. A conductor is placed in the contralateral iliac artery along the conductor. A stent is implanted in the iliac artery lesion. The second stage is the recanalization of the femoral-popliteal segment with angioplasty and stent implantation in the affected area. | Procedure or surgery | Full metall jacket |
Primary outcome
Efficacy of the procedure
Time frame: 24 months
freedom from thrombosis was defined as the absence of occlusion by duplex ultrasonography or CT angiography of the treated segment
Safety of the procedure
Time frame: 30 days
bleeding according to blood loss volume (millilitres) 1. intraoperative blood loss volume; 2.Postoperative blood loss volume by duplex ultrasonography and drainage losses
Safety of the procedure
Time frame: 24 months
major adverse limb events according to clinical evaluation
5 secondary outcomes
Primary patency
Time frame: 24 months
Secondary patency
Time frame: 24 months
Changes in the patients quality of life: questionnaire
Time frame: 24 months
Success of the procedure
Time frame: 1 month
Changes in chronic lower limb ischemia at 24 months follow-up
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 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 Hybrid revascularization and Full metall Jacket in people with Superficial Femoral Artery Stenosis and Iliac Artery Occlusion, 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 14 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 13 Jul 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 Andrey A Karpenko, PHD (89139504100, a_karpenko@meshalkin.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of the procedure (time frame: 24 months). The study lists 3 primary outcomes in all. 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 13 Jul 2020.