Fibrin for Critical limb ischemia

Inclusion criteria

• {"criterion_text":"- To finalize ICF for participation in the study and post-operative rehabilitation."}
• {"criterion_text":"- Symptomatic occlusive atherosclerosis of the lower limb arteries at stages 4 and 5 of the Rutherford scale (critical limb ischemia) confirmed clinically and hemodynamically."}
• {"criterion_text":"- Patients aged 18 years and older, under 90 years old."}
• {"criterion_text":"- Patients without absolute contraindications for undergoing revascularization procedures."}
• {"criterion_text":"- Expected average survival time: more than 3 years (patients will be eligible for the study if their expected perioperative mortality is <5% and the probability of predicted 2-year survival is >50%—such patients will be classified as having medium or high surgical risk)."}

Exclusion criteria

• {"criterion_text":"- To not accept the ICF to participate in the clinical study."}
• {"criterion_text":"- Inability to qualify the patient as a tissue donor due to history or diagnostic test results aimed at detecting contraindications for being a tissue or cell donor, including the presence of biological pathogens as defined by the Act on the Procurement, Storage, and Transplantation of Cells, Tissues, and Organs (Journal of Laws 2005 No. 169 item 1411) and included in the donor qualification form for the Tissue and Cell Bank (Attachment BT01)."}
• {"criterion_text":"- Projected life time shorter than 3 years."}
• {"criterion_text":"- Active cancer (5-year washout period after treatment completion)."}
• {"criterion_text":"- Other comorbidities that shorten the expected survival time to <3 years."}
• {"criterion_text":"- Neurological or psychiatric conditions that, in the investigator's opinion, would prevent adequate cooperation."}
• {"criterion_text":"- Abnormal hematological and biochemical parameters: Hemoglobin: <9.5 g/dl, Platelet count: <50,000/mm³, Bilirubin level: 3 times above the permissible upper limit of normal, AST: 3 times above the permissible upper limit of normal, ALT: 3 times above the permissible upper limit of normal, GFR: below 30 ml/min/1.73 m² (renal failure)."}
• {"criterion_text":"- Absolute contraindications for the use of contrast agents (iodine-based, gadolinium-based, or 18FDG (18F-fluorodeoxyglucose))."}
• {"criterion_text":"- Participation in any other clinical trial or therapeutic experiment (washout period of no less than 120 days)"}
• {"criterion_text":"- Women: pregnancy or positive pregnancy test at the time of inclusion in the study, and non-use of contraception (mechanical or hormonal), or declaration of non-use of contraception (mechanical or hormonal, except in cases of physical sterilization) during the study for premenopausal women. Women in the lactation period."}

Primary endpoints

• {"endpoint_text":"- Primary endpoint: the type and frequency of adverse reactions and events assessed during the study and at the final visit.","definition_or_measurement_approach":"Assessed during the study and at the final visit (type and frequency of adverse reactions and events)."}

Secondary endpoints

• {"endpoint_text":"- Secondary endpoints: mortality rate at the final visit, amputation rate at the final visit, time to revascularization (continuous assessment), amputation-free survival time (continuous assessment), muscle perfusion in imaging studies (at the final visit compared to baseline), ankle-brachial index (at the final visit compared to baseline), change in ischemia scores (Rutherford, WiFI) (at the final visit compared to baseline), and quality of life score at the final visit.","definition_or_measurement_approach":"Mortality rate and amputation rate measured at final visit; time-to-event outcomes (time to revascularization, amputation-free survival) assessed continuously; muscle perfusion by imaging compared to baseline; ankle-brachial index compared to baseline; changes in Rutherford/WIfI scores compared to baseline; quality of life score at final visit."}

Poland

Earliest CTIS Part Ii Submission Date

17-01-2025

Latest Decision Or Authorization Date

09-02-2026

Processing Time Days

388

Number Of Sites

1

Number Of Participants

100

Primary sponsor

Full Name

Medical University Of Warsaw

Organisation Type

Educational Institution

Country Of Registered Address

Poland