Actively Recruiting
The Endovascular Plus GENe Therapy Versus Only EndoVascular Therapy for Severe Limb ischaemiA Trial
Led by Amur State Medical Academy · Updated on 2024-08-05
386
Participants Needed
1
Research Sites
256 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Endovascular Plus GENe Therapy Versus Only EndoVascular Therapy for Severe Limb ischaemiA Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women 18 years of age and older
- Atherosclerotic disease affecting peripheral arteries below the groin
- Severe lower limb ischemia with rest pain or non-healing ulcers, classified as Rutherford 4-5 and Fontaine III-IV
- No prior surgical intervention on the same leg below the groin
- Suitable for endovascular treatment as determined by researchers
- Adequate blood flow into the leg through the aorto-iliac arteries
- Willingness to follow study protocol, attend follow-ups, and provide written consent
You will not qualify if you...
- Non-atherosclerotic artery disease or acute ischemia in the lower limb
- Severe limb ischemia with gangrene (Rutherford category 6)
- Presence of a popliteal aneurysm larger than 2.0 cm in the area of interest
- Life expectancy less than 2 years due to other causes
- Planned high amputation within 4 weeks after the procedure
- Allergy to any components of the study drug
- Previous surgical intervention below the groin on the affected leg
- Open surgery on the inflow arteries of the same leg within 6 weeks before enrollment
- Current chemotherapy or radiation therapy
- Pregnancy or breastfeeding
- Heart attack, bypass surgery, or stroke within 6 weeks before enrollment
- Severe allergic reaction preventing use of iodinated contrast
- Participation in another clinical trial within 30 days
- Inability to understand the study or refusal to consent
- Withdrawal from the study or use of prohibited medications
- Injuries or diseases interfering with study assessments
- Any adverse event or condition posing unacceptable risk as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Amur State Medical Academy
Blagoveshchensk, Amur Oblast, Russia, 675001
Actively Recruiting
Research Team
A
Alrxander Korotkikh, PhD
CONTACT
S
Sergey Radaev
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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