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Compares treatment options for Severe Lower Limb Ischemia
Official title The Endovascular Plus GENe Therapy Versus Only EndoVascular Therapy for Severe Limb ischaemiA Trial
ClinicalTrials.gov ID: NCT06473740
What this study is testing
What is Deoxyribonucleic acid supercoiled plasmid pCMV-VEGF165 (Neovasculgen)?
Deoxyribonucleic acid supercoiled plasmid pCMV-VEGF165 (Neovasculgen) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for severe lower limb ischemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Men and women 18 years of age and older;
- Atherosclerotic infrainguinal disease of the peripheral arteries (occlusive-stenotic lesion below the inguinal fold);
- Severe ischemia of the lower extremity, characterized by pain at rest or a non-healing ischemic ulcer, which corresponds to Rutherford categories 4-5...
- Without any previous surgical intervention of the ipsilateral n/a below the inguinal fold;
- Suitable for endovascular treatment according to researchers;
You likely can't join if
- Refusal of the patient to further participate in the study;
- Use of drugs from the list of prohibited concomitant therapy;
- The use of any other concomitant therapy that, in the opinion of the investigator, may interfere with the assessment of the how well it works and...
- Onset of pregnancy;
- Injuries and damage to the ipsilateral lower limb, which, in the opinion of the investigator, may interfere with the assessment of the how well it...
- The presence of an adverse event that, in the opinion of the investigator, indicates that continued participation in the study poses an unacceptable...
See the full eligibility criteria
- Men and women 18 years of age and older;
- Atherosclerotic infrainguinal disease of the peripheral arteries (occlusive-stenotic lesion below the inguinal fold);
- 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;
- Without any previous surgical intervention of the ipsilateral n/a below the inguinal fold;
- Suitable for endovascular treatment according to researchers;
- Adequate inflow through the aorto-iliac segment;
- Willingness to comply with the study protocol, attend follow-up examinations, comply with all instructions and provide written informed consent. Non-
- Infrainguinal disease of peripheral arteries of non-atherosclerotic origin (aortoarteritis, thromboangiitis, congenital anomalies, vascular injuries, etc.) or acute ischemia;
- Severe ischemia of the lower limb, characterized by gangrene (Rutherford category 6);
- The presence of a popliteal aneurysm (\>2.0 cm) on the area of interest;
- Life expectancy \<2 years, for reasons not related to occlusive-stenotic disease of the arteries of the n/c;
- Planned high amputation on the ipsilateral lower extremity within 4 weeks after the planned endovascular procedure;
- Hypersensitivity to any components included in the study drug;
- Previous surgical intervention below the inguinal fold (open vascular, endovascular or hybrid treatment);
- Open treatment of the inflow tract of the ipsilateral lower limb within 6 weeks before enrollment in the study (aortofemoral, iliofemoral, axillofemoral, femorofemoral bypass);
- Current chemotherapy or radiation therapy;
- Pregnancy or lactation;
- Cases of AMI, CABG or stroke within 6 weeks before enrollment in the study;
- An absolute contraindication to the use of iodinated contrast agent due to a previous severe allergic reaction (laryngospasm, bronchospasm, cardiorespiratory shock or their equivalent);
- Participation in another clinical trial within the previous 30 days;
- The patient's inability to understand the essence of the study;
- Refusal of the patient to sign informed consent.
- Refusal of the patient to further participate in the study;
- Use of drugs from the list of prohibited concomitant therapy;
- The use of any other concomitant therapy that, in the opinion of the investigator, may interfere with the assessment of the how well it works and safety of the investigational medicinal product and/or distort the...
- Onset of pregnancy;
- Injuries and damage to the ipsilateral lower limb, which, in the opinion of the investigator, may interfere with the assessment of the how well it works and safety of the study drug and/or distort the results of the...
- 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.
- The occurrence or identification of concomitant diseases that prevent the patient's further participation in the clinical trial, in the opinion of the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Blagoveshchensk, Amur Oblast, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Blagoveshchensk, Amur Oblast, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.