Peripheral Arterial Occlusive DiseaseNCT05933720
Efficacy and Safety of the Regulatory Polypeptides in Patients With Peripheral Atherosclerosis.
A study testing Polypeptides, Femoral-popliteal bypass grafting with a synthetic graft above the knee and Routine conservative treatment in people with Peripheral Arterial Occlusive Disease, run by Ryazan State Medical University at 1 site in Russia.
Trial summary
The study is aimed at assessing the role of the activity of markers of endothelial dysfunction (cytotoxic malonic aldehyde (MDA), angiotensin II, endothelial nitric oxide synthase (NO), endothelin-1, prostacyclin) in the systemic circulation in patients with lower extremity atherosclerotic arterial occlusive disease… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peripheral Arterial Occlusive Disease
- What is being tested?
- Polypeptides, Femoral-popliteal bypass grafting with a synthetic graft above the knee and Routine conservative treatment
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteRussia
- Study dates
- 1 Apr 2023to 1 Sep 2026
- 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
- men or women over 18 years of age with lower extremity atherosclerotic arterial occlusive disease, confirmed with instrumental work-up methods (ultrasonography or angiography).
Who cannot join
- men or women under 18 years of age; history of anaphylaxis; hypersensitivity to any of the components that make up the drug Slavinorm®, and proteins of animal origin; absolute and relative contraindications to the treadmill test; failure to walk at a minimum speed of 3.2 km/h (2 mph) at a minimum treadmill angle for at least 2 minutes during the stress test during the screening phase; depression of the ST segment more than 1 mm in one or more standard leads on the electrocardiogram; peripheral artery disease not associated with atherosclerosis; patients who underwent reconstructive surgery or invasive interventions on the arteries of the lower extremities in history without a clinic of intermittent claudication; angina pectoris III-IV functional class (FC) according to the CCS classification; body mass index >35 kg/m2; acute or chronic renal (creatinine clearance less than 30 ml / min) and / or liver failure [aspartate aminotransferase (AST), alanine aminotransferase (ALT) > 3 times the upper limit of normal]; chronic heart failure III-IV FC according to NYHA; acute coronary syndrome within 6 months. before the start of the screening period; any clinically significant condition or comorbidity that, in the opinion of the Investigator, would preclude the patient from participating in the study.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
RyazanSMU
Ryazan
Igor Suchkov, +79038362417, suchkov_med@mail.ru
About this study
Official title: Evaluation of the Efficacy and Safety of the Drug Based on Vascular Regulatory Polypeptides for the Treatment of Patients With Lower Extremity Atherosclerotic Arterial Occlusive Disease.
The study is aimed at assessing the role of the activity of markers of endothelial dysfunction (cytotoxic malonic aldehyde (MDA), angiotensin II, endothelial nitric oxide synthase (NO), endothelin-1, prostacyclin) in the systemic circulation in patients with lower extremity atherosclerotic arterial occlusive disease undergoing open reconstructive interventions.
Read the detailed description
The study will include 120 patients of similar age, gender, and ethnicity, they will be divided into four groups: Group I: 30 patients with lower extremity atherosclerotic arterial occlusive disease, stage IIA-IIB of the disease according to the Fontaine-Pokrovsky classification, receiving conservative therapy; Group II: 30 patients with lower extremity atherosclerotic arterial occlusive disease, stage IIA-IIB of the disease according to the Fontaine-Pokrovsky classification, receiving conservative therapy, including the drug based on vascular polypeptides Slavinorm®; Group III: 30 patients with lower extremity atherosclerotic arterial occlusive disease, stageIII-IV of the disease according to the Fontaine-Pokrovsky classification, receiving conservative therapy in combination with surgical methods of treatment (femoral-popliteal bypass grafting with a synthetic graft above the knee); Group IV: 30 patients with lower extremity atherosclerotic arterial occlusive disease, stage III-IV of the disease according to the Fontaine-Pokrovsky classification, receiving conservative therapy, including the drug based on vascular polypeptides Slavinorm®, in combination with surgical methods of treatment (femoral-popliteal bypass grafting with a synthetic graft above the knee).
- Conditions
- Peripheral Arterial Occlusive Disease
- Being tested
- Polypeptides, Femoral-popliteal bypass grafting with a synthetic graft above the knee, Routine conservative treatment
- Keywords
- Peripheral Arterial Disease, bypass grafting, polypeptides
- Medical subject headings
- Peripheral Arterial Occlusive Disease 1, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolypeptidesDrug
Also called vascular polypeptides Slavinorm®, a derivative from cattle vessels
The patients will undergo treatment with a drug based on vascular polypeptides Slavinorm®, a derivative from cattle vessels, registered in Russia for the treatment of patients with peripheral atherosclerotic occlusive disease.
Femoral-popliteal bypass grafting with a synthetic graft above the kneeDevice
The patients with undergo an arterial revascularization - Femoral-popliteal bypass grafting with a synthetic graft above the knee
Routine conservative treatmentOther
The patients will undergo routine conservative treatment as per clinical guidelines (acetylsalicylic acid 100mg daily, atorvastatin 20mg daily)
| Study group | Role | What they receive |
|---|---|---|
| Patients who undergo routine conservative treatment | Active comparator | The patients who undergo routine conservative treatment for peripheral atherosclerotic occlusive disease as per clinical guidelines Receives: Other: Routine conservative treatment |
| Patients who undergo treatment with polypeptides | Experimental | The patients who undergo treatment with a complex of polypeptides isolated from the vessels of cattle is administered in / m, adults 1 vial (5 mg) 1 time / day 2 times a week. The course of treatment is 10 injections. Receives: Drug: Polypeptides |
| Patients who undergo femoral-popliteal bypass with a synthetic graft above the knee | Active comparator | Patients who undergo the surgical method of treatment i.e. femoral-popliteal bypass grafting with a synthetic graft above the knee and routine conservative treatment as per clinical guidelines Receives: Device: Femoral-popliteal bypass grafting with a synthetic graft above the knee; Other: Routine conservative treatment |
| Patients who undergo femoral-popliteal bypass grafting and treatment with polypeptides | Experimental | Patients who undergo the surgical method of treatment i.e. femoral-popliteal bypass grafting with a synthetic graft above the knee with following treatment with a complex of polypeptides isolated from the vessels of cattle is administered in / m, adults 1 vial (5 mg) 1 time / day 2 times a week. The course of treatment is 10 injections. Receives: Drug: Polypeptides; Device: Femoral-popliteal bypass grafting with a synthetic graft above the knee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower artery or bypass graft thrombosis
The rate of the Lower artery or bypass graft thrombosis
Measured: 1 year
disease progression
The rate of the disease progression
Measured: 1 year
restenosis
Restenosis rate
Measured: 1 year
Secondary outcomes (3)
limb loss
Limb loss rate
Measured: 1 year
changes in pain-free walking distance
Changes in the parameter of pain-free walking distance (in meters)
Measured: 1 year
changes in ankle-brachial index
Changes in the parameter of ankle-brachial index measured at rest
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start1 Apr 2023
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial Occlusive DiseaseStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- An open, prospective study is aimed at enrolling 120 patients with lower extremity atherosclerotic arterial occlusive disease. Patients are planned to undergo conservative therapy according to indications, including the use of a drug based on vascular polypeptides Slavinorm®, as well as a combination of conservative therapy, including a drug based on vascular polypeptides Slavinorm®, with surgical methods of treatment (femoral-popliteal bypass grafting with a synthetic graft above the knee). Subjects of similar age, gender, and ethnicity should be divided into four groups, respectively.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ryazan State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lyasheva Anastasia Vladimirovna, Ryazan State Medical University
- Investigators
- Igor Suchkov, Study chair, Ryazan State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933720
- Sponsor's protocol ID
- 10
- Status last verified
- Jun 2023
- First submitted
- 27 Jun 2023
- Last updated
- 6 Jul 2023
- 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 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of the Drug Based on Vascular Regulatory Polypeptides for the Treatment of Patients With Lower Extremity Atherosclerotic Arterial Occlusive Disease.
- ClinicalTrials.gov ID
- NCT05933720
- Acronym / sponsor ID
- 10
- Conditions
- Peripheral Arterial Occlusive Disease
- Keywords
- Peripheral Arterial Disease, bypass grafting, polypeptides
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ryazan State Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 6 Jul 2023 (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.
The study is aimed at assessing the role of the activity of markers of endothelial dysfunction (cytotoxic malonic aldehyde (MDA), angiotensin II, endothelial nitric oxide synthase (NO), endothelin-1, prostacyclin) in the systemic circulation in patients with lower extremity atherosclerotic arterial occlusive disease undergoing open reconstructive interventions.
Detailed description
The study will include 120 patients of similar age, gender, and ethnicity, they will be divided into four groups: Group I: 30 patients with lower extremity atherosclerotic arterial occlusive disease, stage IIA-IIB of the disease according to the Fontaine-Pokrovsky classification, receiving conservative therapy; Group II: 30 patients with lower extremity atherosclerotic arterial occlusive disease, stage IIA-IIB of the disease according to the Fontaine-Pokrovsky classification, receiving conservative therapy, including the drug based on vascular polypeptides Slavinorm®; Group III: 30 patients with lower extremity atherosclerotic arterial occlusive disease, stageIII-IV of the disease according to the Fontaine-Pokrovsky classification, receiving conservative therapy in combination with surgical methods of treatment (femoral-popliteal bypass grafting with a synthetic graft above the knee); Group IV: 30 patients with lower extremity atherosclerotic arterial occlusive disease, stage III-IV of the disease according to the Fontaine-Pokrovsky classification, receiving conservative therapy, including the drug based on vascular polypeptides Slavinorm®, in combination with surgical methods of treatment (femoral-popliteal bypass grafting with a synthetic graft above the knee).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- An open, prospective study is aimed at enrolling 120 patients with lower extremity atherosclerotic arterial occlusive disease. Patients are planned to undergo conservative therapy according to indications, including the use of a drug based on vascular polypeptides Slavinorm®, as well as a combination of conservative therapy, including a drug based on vascular polypeptides Slavinorm®, with surgical methods of treatment (femoral-popliteal bypass grafting with a synthetic graft above the knee). Subjects of similar age, gender, and ethnicity should be divided into four groups, respectively.
| Arm | Type | Receives |
|---|---|---|
| Patients who undergo routine conservative treatment | Active comparator | Other: Routine conservative treatmentThe patients who undergo routine conservative treatment for peripheral atherosclerotic occlusive disease as per clinical guidelines |
| Patients who undergo treatment with polypeptides | Experimental | Drug: PolypeptidesThe patients who undergo treatment with a complex of polypeptides isolated from the vessels of cattle is administered in / m, adults 1 vial (5 mg) 1 time / day 2 times a week. The course of treatment is 10 injections. |
| Patients who undergo femoral-popliteal bypass with a synthetic graft above the knee | Active comparator | Device: Femoral-popliteal bypass grafting with a synthetic graft above the knee, Other: Routine conservative treatmentPatients who undergo the surgical method of treatment i.e. femoral-popliteal bypass grafting with a synthetic graft above the knee and routine conservative treatment as per clinical guidelines |
| Patients who undergo femoral-popliteal bypass grafting and treatment with polypeptides | Experimental | Drug: Polypeptides, Device: Femoral-popliteal bypass grafting with a synthetic graft above the kneePatients who undergo the surgical method of treatment i.e. femoral-popliteal bypass grafting with a synthetic graft above the knee with following treatment with a complex of polypeptides isolated from the vessels of cattle is administered in / m, adults 1 vial (5 mg) 1 time / day 2 times a week. The course of treatment is 10 injections. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- men or women over 18 years of age with lower extremity atherosclerotic arterial occlusive disease, confirmed with instrumental work-up methods (ultrasonography or angiography).
Key exclusion criteria (1 listed)
- men or women under 18 years of age; history of anaphylaxis; hypersensitivity to any of the components that make up the drug Slavinorm®, and proteins of animal origin; absolute and relative contraindications to the treadmill test; failure to walk at a minimum speed of 3.2 km/h (2 mph) at a minimum treadmill angle for at least 2 minutes during the stress test during the screening phase; depression of the ST segment more than 1 mm in one or more standard leads on the electrocardiogram; peripheral artery disease not associated with atherosclerosis; patients who underwent reconstructive surgery or invasive interventions on the arteries of the lower extremities in history without a clinic of intermittent claudication; angina pectoris III-IV functional class (FC) according to the CCS classification; body mass index >35 kg/m2; acute or chronic renal (creatinine clearance less than 30 ml / min) and / or liver failure [aspartate aminotransferase (AST), alanine aminotransferase (ALT) > 3 times the upper limit of normal]; chronic heart failure III-IV FC according to NYHA; acute coronary syndrome within 6 months. before the start of the screening period; any clinically significant condition or comorbidity that, in the opinion of the Investigator, would preclude the patient from participating in the study.
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 |
|---|---|---|
| PolypeptidesAlso: vascular polypeptides Slavinorm®, a derivative from cattle vesselsThe patients will undergo treatment with a drug based on vascular polypeptides Slavinorm®, a derivative from cattle vessels, registered in Russia for the treatment of patients with peripheral atherosclerotic occlusive disease. | Drug | Patients who undergo femoral-popliteal bypass grafting and treatment with polypeptides, Patients who undergo treatment with polypeptides |
| Femoral-popliteal bypass grafting with a synthetic graft above the kneeThe patients with undergo an arterial revascularization - Femoral-popliteal bypass grafting with a synthetic graft above the knee | Device | Patients who undergo femoral-popliteal bypass grafting and treatment with polypeptides, Patients who undergo femoral-popliteal bypass with a synthetic graft above the knee |
| Routine conservative treatmentThe patients will undergo routine conservative treatment as per clinical guidelines (acetylsalicylic acid 100mg daily, atorvastatin 20mg daily) | Other | Patients who undergo femoral-popliteal bypass with a synthetic graft above the knee, Patients who undergo routine conservative treatment |
Primary outcome
Lower artery or bypass graft thrombosis
Time frame: 1 year
The rate of the Lower artery or bypass graft thrombosis
disease progression
Time frame: 1 year
The rate of the disease progression
restenosis
Time frame: 1 year
Restenosis rate
3 secondary outcomes
limb loss
Time frame: 1 year
changes in pain-free walking distance
Time frame: 1 year
changes in ankle-brachial index
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
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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.
Igor Suchkov study chair
Ryazan State Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polypeptides, Femoral-popliteal bypass grafting with a synthetic graft above the knee and Routine conservative treatment in people with Peripheral Arterial Occlusive Disease, run by Ryazan State Medical University 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 1 inclusion and 1 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 6 Jul 2023. 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 Igor Aleksadrovich Suchkov (8-903-836-24-17, suchkov_med@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower artery or bypass graft thrombosis (time frame: 1 year). 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 6 Jul 2023.