Clinical trial NCT05455138: Allografts in Surgery of the Main Arteries
Official title: Allografts in Surgery of the Main Arteries
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Critical Lower Limb Ischemia
Keywords: Critical Lower Limb Ischemia
atherosclerosis
peripheral arterial disease
Lead sponsor: Ryazan State Medical University
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility 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.

Primary outcomes:
measure: Number of Participants with lethal outcomes
timeFrame: 24 months
Secondary outcomes:
measure: Number of Participants with Graft thrombosis
timeFrame: 24 months
measure: Myocardial infarction
timeFrame: 1, 3, 6, 12, 18, and 24 months
measure: Number of Participants with Acute coronary syndrome
timeFrame: 24 months
measure: Number of Participants with Stroke or transient ischemic attack
timeFrame: 24 months
Other outcomes:
Locations:
city: Ryazan
country: Russian Federation
facility: Ryazan State Medical University
Study officials:
affiliation: Ryazan State Medical University
name: Igor Suchkov, PhD, DMedSc
role: PRINCIPAL_INVESTIGATOR
References: