Using biological grafts for artery surgery in patients with critical limb ischemia
Allografts in Surgery of the Main Arteries
This study is testing different types of biological grafts in artery surgery to see which works best for people with severe leg circulation problems caused by atherosclerosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ryazan State Medical University Academic / other |
| Locations | 1 site (Ryazan) |
| Trial ID | NCT05455138 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of various biological grafts, including allogeneic arterial and venous grafts, autologous veins, and biological bovine decellularized grafts, in bypass surgeries for patients suffering from critical lower limb ischemia caused by atherosclerosis. A total of 200 patients will be monitored over two years to assess outcomes such as mortality, graft thrombosis, and cardiovascular events. The study will also analyze the physical properties of the grafts and markers of endothelial dysfunction at different preservation time points.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with critical lower limb ischemia due to atherosclerotic peripheral arterial disease.
Not a fit: Patients under 18 years old, those with decompensated concomitant pathology, or who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes and quality of life for patients with critical lower limb ischemia.
How similar studies have performed: While similar approaches have been explored, this specific combination of biological grafts in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * males or females over 18 years of age; * critical lower limb ischemia due to atherosclerotic peripheral arterial disease. Exclusion Criteria: * males or females less than 18 year of age; * decompensated concomitant pathology; * pregnancy or lactation.
Where this trial is running
Ryazan
- Ryazan State Medical University — Ryazan, Russian Federation (Recruiting)
Study contacts
- Principal investigator: Igor Suchkov, PhD, DMedSc — Ryazan State Medical University
- Study coordinator: Igor Suchkov, PhD, DMedSc
- Email: suchkov_med@mail.ru
- Phone: +7 (4912) 97-18-01
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.