The Endovascular Plus GENe Therapy Versus Only EndoVascular Therapy for Severe Limb ischaemiA Trial

Launched by AMUR STATE MEDICAL ACADEMY · Jun 19, 2024

Keywords

ClinConnect Summary

The GENEVA trial is studying two different treatment approaches for patients suffering from severe lower limb ischemia, a condition where the blood flow to the legs is significantly reduced, causing pain and non-healing sores. This trial compares the standard endovascular treatment, which involves minimally invasive procedures to improve blood flow, with an enhanced treatment that includes gene therapy. The researchers hope that combining these two methods will lead to fewer surgeries and amputations, as well as longer periods before any further procedures are needed.

To participate in this study, individuals need to be at least 18 years old and have severe ischemia due to atherosclerosis (hardening of the arteries) in the lower limbs. They should not have had previous surgeries in the affected area and must be suitable for endovascular treatment. Participants will be monitored closely throughout the trial, and their progress will be tracked to see how well each treatment works. This trial is currently recruiting participants, and those who join will contribute to important research that could improve treatment options for people with severe lower limb ischemia.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Men and women 18 years of age and older;
• • 2. Atherosclerotic infrainguinal disease of the peripheral arteries (occlusive-stenotic lesion below the inguinal fold);
• • 3. Severe ischemia of the lower extremity, characterized by pain at rest or a non-healing ischemic ulcer, which corresponds to Rutherford categories 4-5 and Fontaine grades III-IV;
• • 4. Without any previous surgical intervention of the ipsilateral n/a below the inguinal fold;
• • 5. Suitable for endovascular treatment according to researchers;
• • 6. Adequate inflow through the aorto-iliac segment;
• • 7. Willingness to comply with the study protocol, attend follow-up examinations, comply with all instructions and provide written informed consent.
• Non-inclusion criteria:
• • 1. Infrainguinal disease of peripheral arteries of non-atherosclerotic origin (aortoarteritis, thromboangiitis, congenital anomalies, vascular injuries, etc.) or acute ischemia;
• • 2. Severe ischemia of the lower limb, characterized by gangrene (Rutherford category 6);
• • 3. The presence of a popliteal aneurysm (\>2.0 cm) on the area of interest;
• • 4. Life expectancy \<2 years, for reasons not related to occlusive-stenotic disease of the arteries of the n/c;
• • 5. Planned high amputation on the ipsilateral lower extremity within 4 weeks after the planned endovascular procedure;
• • 6. Hypersensitivity to any components included in the study drug;
• • 7. Previous surgical intervention below the inguinal fold (open vascular, endovascular or hybrid treatment);
• • 8. Open treatment of the inflow tract of the ipsilateral lower limb within 6 weeks before enrollment in the study (aortofemoral, iliofemoral, axillofemoral, femorofemoral bypass);
• • 9. Current chemotherapy or radiation therapy;
• • 10. Pregnancy or lactation;
• • 11. Cases of AMI, CABG or stroke within 6 weeks before enrollment in the study;
• • 12. An absolute contraindication to the use of iodinated contrast agent due to a previous severe allergic reaction (laryngospasm, bronchospasm, cardiorespiratory shock or their equivalent);
• • 13. Participation in another clinical trial within the previous 30 days;
• • 14. The patient's inability to understand the essence of the study;
• • 15. Refusal of the patient to sign informed consent.
• Exclusion Criteria:
• • 1. Refusal of the patient to further participate in the study;
• • 2. Use of drugs from the list of prohibited concomitant therapy;
• • 3. The use of any other concomitant therapy that, in the opinion of the investigator, may interfere with the assessment of the effectiveness and safety of the investigational medicinal product and/or distort the results of the study;
• • 4. Onset of pregnancy;
• • 5. Injuries and damage to the ipsilateral lower limb, which, in the opinion of the investigator, may interfere with the assessment of the effectiveness and safety of the study drug and/or distort the results of the study;
• • 6. The presence of an adverse event that, in the opinion of the investigator, indicates that continued participation in the study poses an unacceptable risk for the patient.
• • 7. The occurrence or identification of concomitant diseases that prevent the patient's further participation in the clinical trial, in the opinion of the investigator.