Ignite Creation Date:
2024-07-17 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06473740
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-02-29
Brief Title:
The Endovascular Plus GENe Therapy Versus Only EndoVascular Therapy for Severe Limb ischaemiA Trial
Sponsor:
Amur State Medical Academy
Organization:
Amur State Medical Academy
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
GENEVA is the worlds 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
Detailed Description:
Objective - To prove the effectiveness and safety of combined endovascular treatment and gene therapy for Fontaine grades III and IV CI Rutherford grades 4 and 5 in comparison with isolated endovascular treatment by comparing the immediate and long-term results of the two techniques assessed using clinical and instrumental methods
Null hypothesis Н0 - After endovascular treatment in combination with gene therapy with supercoiled plasmid deoxyribonucleic acid pCMV-VEGF165 in patients with critical ischemia of the lower limb III and IV degrees according to Fontaine categories 4 and 5 according to Rutherford the number of re-interventions on the operated segment and the number high amputations will be the same as after isolated endovascular treatment
The frequency of re-interventions on the operated segment during endovascular interventions in the long-term period according to the main randomized clinical trials BASIL 1 BASIL 2 BEST-CLI is 259 190 235 and the number of high amputations BASIL 1 BASIL 2 - 191 and 180 respectively High amputations lead to disability and loss of performance incl and working population Within 5 years after major amputation more than half of patients die from concomitant diseases Each repeat revascularization is significantly more difficult and longer than the previous intervention reducing the potential for future interventions
In this regard the search for new modern minimally invasive methods for the treatment of critical ischemia of the lower extremities which will help to significantly reduce the number of high amputations and repeated interventions as well as increase the intervals between repeated interventions is an extremely important medical and economic problem
Null hypothesis Н0 - After endovascular treatment in combination with gene therapy with supercoiled plasmid deoxyribonucleic acid pCMV-VEGF165 in patients with critical ischemia of the lower limb III and IV degrees according to Fontaine categories 4 and 5 according to Rutherford the number of re-interventions on the operated segment and the number high amputations will be the same as after isolated endovascular treatment
The frequency of re-interventions on the operated segment during endovascular interventions in the long-term period according to the main randomized clinical trials BASIL 1 BASIL 2 BEST-CLI is 259 190 235 and the number of high amputations BASIL 1 BASIL 2 - 191 and 180 respectively High amputations lead to disability and loss of performance incl and working population Within 5 years after major amputation more than half of patients die from concomitant diseases Each repeat revascularization is significantly more difficult and longer than the previous intervention reducing the potential for future interventions
In this regard the search for new modern minimally invasive methods for the treatment of critical ischemia of the lower extremities which will help to significantly reduce the number of high amputations and repeated interventions as well as increase the intervals between repeated interventions is an extremely important medical and economic problem
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None