AzTrials
AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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
Show all 14Show fewer
  • 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.

Andrey A Karpenko, PHD contact

89139504100

a_karpenko@meshalkin.ru

Russia1 site, 1 recruiting
  • Meshalkin Research Institute of Pathology of Circulation

    Novosibirsk, Novosibirskaya Obl, 630055

    Andrey A Karpenko, PHD, 89134504100, a_karpenko@meshalkin.ru

    Recruiting

Other trials in Russia

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 groups in NCT04461496
Study groupRoleWhat they receive
Hybrid revascularizationActive comparator50 hybrid procedure
Receives: Procedure: Hybrid revascularization
Full metall jacketExperimental50 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.

  1. 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

  2. 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

  3. Safety of the procedure

    major adverse limb events according to clinical evaluation

    Measured: 24 months

Secondary outcomes (5)
  1. Primary patency

    Primary patency rate at 24 months follow-up

    Measured: 24 months

  2. Secondary patency

    Secondary patency rate at 24 months follow-up

    Measured: 24 months

  3. 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

  4. Success of the procedure

    the number of successful attempts

    Measured: 1 month

  5. 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.

  1. First posted8 Jul 2020
  2. Study start30 Jun 2020
  3. Primary completion5 Jun 2025 (estimated)
  4. Study completion5 Jun 2025 (estimated)

Resources

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)
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

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.

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