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RecruitingPhase 4NCT06473740

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

Multicenter Randomized Prospective Controlled Trial of the Clinical Effectiveness of a Best Endovascular Treatment Versus a Best Endovascular Treatment in Combination With Gene Therapy for Severe Limb Ischemia

Sponsor

Amur State Medical Academy

Enrollment

386 participants

Start Date

Jun 20, 2024

Study Type

INTERVENTIONAL

Conditions

Severe Lower Limb Ischemia

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria22

  • 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.
  • 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.

Exclusion Criteria7

  • 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 effectiveness and safety of the investigational medicinal product and/or distort the results of the study;
  • 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 effectiveness and safety of the study drug and/or distort the results of the study;
  • 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.
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Interventions

DRUGDeoxyribonucleic acid supercoiled plasmid pCMV-VEGF165 (Neovasculgen)

The drug "Neovasculgen" is a highly purified supercoiled form of the pCMV-VEGF165 plasmid, encoding the Vascular endothelial growth factor (VEGF) under the control of a promoter (DNA control region). Recombinant plasmid DNA consists of the following components: a fragment of the regulatory region (22 nucleotide pairs), which determines the transcription of the gene, the VEGF minigene, upon expression of which the VEGF isoform is synthesized, consisting of 165 amino acids, a splicing signal, a polyadenylation signal and the SV40 transcription terminator, ensuring the synthesis of the mature RNA gene and auxiliary regions required for efficient biosynthesis of plasmid DNA in the cells of the producer strain of Escherichia coli. When molecules of this plasmid penetrate into mammalian cells, VEGF is produced, which stimulates endothelial cells, which leads to the growth of blood vessels (vascularization) in the area of injection.

Locations(1)

Amur State Medical Academy

Blagoveshchensk, Amur Oblast, Russia

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NCT06473740