drugset / Trial / NCT06473740
The Endovascular Plus GENe Therapy Versus Only EndoVascular Therapy for Severe Limb ischaemiA Trial
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Deoxyribonucleic acid supercoiled plasmid pCMV-VEGF165 | Unknown | 1.2 mg | Intramuscular |