drugset / Trial / NCT06473740

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

NCT06473740 ↗

Phase 4 Recruiting 386 enrolled Amur State Medical Academy
RandomizedParallel-groupOpen-labelTreatment

Summary

GENEVA is the world's first multicenter, randomized, prospective, controlled trial of the clinical effectiveness of best endovascular treatment versus best endovascular treatment combined with gene therapy for severe lower limb ischemia (Rutherford categories 4 and 5). The researchers hypothesized that the combination treatment would significantly reduce the number of re-interventions on the operated segment and high amputations, and also significantly increase the time interval between re-interventions.

Timeline

Start
2024-06-20
Primary completion
2027-05-19
Completion
2029-05-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Deoxyribonucleic acid supercoiled plasmid pCMV-VEGF165 Unknown 1.2 mg Intramuscular

Indications