Trial Comparing Best Endovascular Treatment Alone Versus Combined With Gene Therapy for Severe Limb Ischemia

What this Trial Is About

Researchers are investigating the combined use of best endovascular treatment and gene therapy for people with severe lower limb ischemia, specifically those classified under Rutherford categories 4 and 5 and Fontaine grades III and IV. This trial aims to compare this combination approach to standard endovascular treatment alone, hypothesizing that adding gene therapy may reduce repeat interventions and high amputations, and increase the time between needed treatments. The study addresses a critical medical need as current treatments often require multiple interventions and have high rates of major amputations, which lead to disability and increased mortality. The study has two groups one receiving the standard best endovascular treatment, which includes arterial stenting or balloon angioplasty, and the other group receiving this same treatment plus gene therapy with Neovasculgen. Neovasculgen is a drug containing a supercoiled plasmid DNA that stimulates new blood vessel growth. This gene therapy is given by intramuscular injection in two doses, on days 7 and 21 after the endovascular procedure. The trial is randomized and controlled, with patients assigned to either treatment group. Participants will be monitored over two years to assess outcomes such as freedom from repeated interventions and high amputations, pain levels, ulcer healing, walking distance, and overall survival. The study includes regular clinical and instrumental assessments, including hemodynamic measurements and safety monitoring for serious adverse events. The research team will also track major adverse limb and cardiovascular events during this period. Participants will need to attend follow-up visits and comply with study instructions throughout the study duration.

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