Critical Lower Limb IschemiaNCT05455138
Allografts in Surgery of the Main Arteries
A study testing Arterial bypass grafting in people with Critical Lower Limb Ischemia, run by Ryazan State Medical University at 1 site in Russia.
Trial summary
The study will examine the results of the use of biological materials (allogeneic arterial grafts, allogeneic venous graft, autologous vein, biological bovine decellularized graft) as a bypass grafts for reconstructive interventions in patients with critical lower limb ischemia due to atherosclerotic peripheral… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Lower Limb Ischemia
- What is being tested?
- Arterial bypass grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteRussia
- Study dates
- 1 Dec 2021to 1 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- males or females over 18 years of age;
- critical lower limb ischemia due to atherosclerotic peripheral arterial disease.
Who cannot join
- males or females less than 18 year of age;
- decompensated concomitant pathology;
- pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Ryazan State Medical University
Ryazan, 390026
Vyacheslav В Karpov, PhD, +79105616427, sdrr.s@yandex.ru
About this study
The study will examine the results of the use of biological materials (allogeneic arterial grafts, allogeneic venous graft, autologous vein, biological bovine decellularized graft) as a bypass grafts for reconstructive interventions in patients with critical lower limb ischemia due to atherosclerotic peripheral arterial disease in the short-term and long-term postoperative periods. Histological analysis of allogeneic grafts will be carried out at various time points of graft preservation with a Roswell Park Memorial Institute 1640 cell medicum with 400mcg/ml gentamicin and 20mcg/ml fluconazole at a temperature of +4C.
The physical properties of allogeneic grafts from postmortem donors (tensile and tear strength) will be evaluated at various conservation time periods (1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks). Markers of endothelial dysfunction (IL-6, endothelin-1, 6-keto-prostaglandin F1alfa, eNOS) will be evaluated in patients with critical ischemia who undergo bypass procedures with arterial and venous allografts at various time points (before surgery, 7 days, 1 month, 3 months, 6 months, 1 year after).
Read the detailed description
The study will include 200 patients of similar age, gender, and ethnicity, who will be divided into four groups:
Group I: 50 patients who undergo arterial bypass procedures using autologous venous graft derived from great saphenous vein; Group II: 50 patients who undergo arterial bypass procedures using allogeneic venous grafts; Group III: 50 patients who undergo arterial bypass procedures using allogeneic arterial grafts; Group IV: 50 patients using biological bovine decellularized grafts.
Patients will be monitored for 2 years: at inclusion, and 1, 3, 6, 12, 18, and 24 months after bypass procedures.
The primary endpoint of the study will be mortality, i.e. death of the patient from any cause. Secondary endpoints of the study will be graft thrombosis and cardiovascular events such as myocardial infarction, acute coronary syndrome, transient ischemic attack, and stroke.
- Conditions
- Critical Lower Limb Ischemia
- Being tested
- Arterial bypass grafting
- Keywords
- Critical Lower Limb Ischemia, atherosclerosis, peripheral arterial disease
- 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.
Arterial bypass graftingProcedure or surgery
Arterial bypass grafting in patients with critical limb ischemia due to peripheral artery disease
| Study group | Role | What they receive |
|---|---|---|
| Arterial bypass procedures using autologous venous graft | Experimental | Patients with critical lower limb ischemia due to atherosclerotic peripheral arterial disease who undergo arterial bypass procedures using autologous venous graft Receives: Procedure: Arterial bypass grafting |
| Arterial bypass procedures using allogeneic venous graft | Experimental | Patients with critical lower limb ischemia due to atherosclerotic peripheral arterial disease who undergo arterial bypass procedures using allogeneic venous graft Receives: Procedure: Arterial bypass grafting |
| Arterial bypass procedures using allogeneic arterial graft | Experimental | Patients with critical lower limb ischemia due to atherosclerotic peripheral arterial disease who undergo arterial bypass procedures using allogeneic arterial graft Receives: Procedure: Arterial bypass grafting |
| Arterial bypass procedures using biologic bovine decellularized arterial graft | Experimental | Patients with critical lower limb ischemia due to atherosclerotic peripheral arterial disease who undergo arterial bypass procedures using biologic bovine decellularized arterial graft Receives: Procedure: Arterial bypass grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with lethal outcomes
The primary outcome measure is mortality rate
Measured: 24 months
Secondary outcomes (4)
Number of Participants with Graft thrombosis
The secondary outcome measure is graft thrombosis
Measured: 24 months
Myocardial infarction
The secondary outcome measure is myocardial infarction
Measured: 1, 3, 6, 12, 18, and 24 months
Number of Participants with Acute coronary syndrome
The secondary outcome measure is acute coronary syndrome
Measured: 24 months
Number of Participants with Stroke or transient ischemic attack
The secondary outcome measure is stroke or transient ischemic attack
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 posted13 Jul 2022
- Study start1 Dec 2021
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical Lower Limb IschemiaStudies 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
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ryazan State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Igor Suchkov, PhD, DMedSc, Principal investigator, Ryazan State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455138
- Sponsor's protocol ID
- 4
- Status last verified
- Nov 2023
- First submitted
- 4 Jul 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kalinin RE, Suchkov IA, Karpov VV, Klimentova EA, Egorov AA, Nikiforov AA. [Biomarkers of endothelial dysfunction after operations using homografts for lower limb arterial reconstruction (a pilot study)]. Angiol Sosud Khir. 2024 Mar 29;30(1):138-145. doi: 10.33029/1027-6661-2024-30-1-138-145. Russian.
PubMed 41801878
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allografts in Surgery of the Main Arteries
- ClinicalTrials.gov ID
- NCT05455138
- Acronym / sponsor ID
- 4
- Conditions
- Critical Lower Limb Ischemia
- Keywords
- Critical Lower Limb Ischemia, atherosclerosis, peripheral arterial disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ryazan State Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 13 Jul 2022 (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 will examine the results of the use of biological materials (allogeneic arterial grafts, allogeneic venous graft, autologous vein, biological bovine decellularized graft) as a bypass grafts for reconstructive interventions in patients with critical lower limb ischemia due to atherosclerotic peripheral arterial disease in the short-term and long-term postoperative periods. Histological analysis of allogeneic grafts will be carried out at various time points of graft preservation with a Roswell Park Memorial Institute 1640 cell medicum with 400mcg/ml gentamicin and 20mcg/ml fluconazole at a temperature of +4C.
The physical properties of allogeneic grafts from postmortem donors (tensile and tear strength) will be evaluated at various conservation time periods (1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks). Markers of endothelial dysfunction (IL-6, endothelin-1, 6-keto-prostaglandin F1alfa, eNOS) will be evaluated in patients with critical ischemia who undergo bypass procedures with arterial and venous allografts at various time points (before surgery, 7 days, 1 month, 3 months, 6 months, 1 year after).
Detailed description
The study will include 200 patients of similar age, gender, and ethnicity, who will be divided into four groups:
Group I: 50 patients who undergo arterial bypass procedures using autologous venous graft derived from great saphenous vein; Group II: 50 patients who undergo arterial bypass procedures using allogeneic venous grafts; Group III: 50 patients who undergo arterial bypass procedures using allogeneic arterial grafts; Group IV: 50 patients using biological bovine decellularized grafts.
Patients will be monitored for 2 years: at inclusion, and 1, 3, 6, 12, 18, and 24 months after bypass procedures.
The primary endpoint of the study will be mortality, i.e. death of the patient from any cause. Secondary endpoints of the study will be graft thrombosis and cardiovascular events such as myocardial infarction, acute coronary syndrome, transient ischemic attack, and stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arterial bypass procedures using autologous venous graft | Experimental | Procedure: Arterial bypass graftingPatients with critical lower limb ischemia due to atherosclerotic peripheral arterial disease who undergo arterial bypass procedures using autologous venous graft |
| Arterial bypass procedures using allogeneic venous graft | Experimental | Procedure: Arterial bypass graftingPatients with critical lower limb ischemia due to atherosclerotic peripheral arterial disease who undergo arterial bypass procedures using allogeneic venous graft |
| Arterial bypass procedures using allogeneic arterial graft | Experimental | Procedure: Arterial bypass graftingPatients with critical lower limb ischemia due to atherosclerotic peripheral arterial disease who undergo arterial bypass procedures using allogeneic arterial graft |
| Arterial bypass procedures using biologic bovine decellularized arterial graft | Experimental | Procedure: Arterial bypass graftingPatients with critical lower limb ischemia due to atherosclerotic peripheral arterial disease who undergo arterial bypass procedures using biologic bovine decellularized arterial graft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- males or females over 18 years of age;
- critical lower limb ischemia due to atherosclerotic peripheral arterial disease.
Key exclusion criteria (3 listed)
- males or females less than 18 year of age;
- decompensated concomitant pathology;
- pregnancy or lactation.
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 |
|---|---|---|
| Arterial bypass graftingArterial bypass grafting in patients with critical limb ischemia due to peripheral artery disease | Procedure or surgery | Arterial bypass procedures using allogeneic arterial graft, Arterial bypass procedures using allogeneic venous graft, Arterial bypass procedures using autologous venous graft, Arterial bypass procedures using biologic bovine decellularized arterial graft |
Primary outcome
Number of Participants with lethal outcomes
Time frame: 24 months
The primary outcome measure is mortality rate
4 secondary outcomes
Number of Participants with Graft thrombosis
Time frame: 24 months
Myocardial infarction
Time frame: 1, 3, 6, 12, 18, and 24 months
Number of Participants with Acute coronary syndrome
Time frame: 24 months
Number of Participants with Stroke or transient ischemic attack
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 18 Nov 2023.
- Derived from this study: PubMed 41801878Kalinin RE, Suchkov IA, Karpov VV, Klimentova EA, Egorov AA, Nikiforov AA. [Biomarkers of endothelial dysfunction after operations using homografts for lower limb arterial reconstruction (a pilot study)]. Angiol Sosud Khir. 2024 Mar 29;30(1):138-145. doi: 10.33029/1027-6661-2024-30-1-138-145. Russian.
- Individual participant dataSharing planned: No
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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, PhD, DMedSc principal investigator
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 Arterial bypass grafting in people with Critical Lower Limb Ischemia, 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 2 inclusion and 3 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 18 Nov 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 Suchkov, PhD, DMedSc (+7 (4912) 97-18-01, suchkov_med@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with lethal outcomes (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05455138, which also lists 1 linked publication.
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 18 Nov 2023.