Patients with abdominal aortic aneurysm undergoing endovascular surgical repair.
Conditions
Brief summary
Proportion of procedure-related adverse events occurring throughout the study., Proportion of adverse events related to allogeneic adipose tissue-derived mesenchymal stem cell infusion occurred throughout the study., Proportion of patients with major adverse cerebral and cardiovascular events (MACCE) within 12 months after treatment.
Detailed description
Reduction of the size of the aneurysm sac in the imaging tests performed during follow-up (CT and Doppler echo). A reduction in the maximum diameter of the aneurysm sac greater than or equal to 5mm in a period of 6 months is considered significant., Percentage of patients with stent migration compared to the historical cohort., Percentage of patients with presence of leaks on control CT at 1 month and 1 year compared to the historical cohort., Reoperation rate at 1 year compared to historical cohort., Hospital admission rate compared to the historical cohort., Assessment of change in quality of life: specific quality of life assessment survey at one month and one year after treatment with respect to baseline. A 10% change in quality of life scores is considered clinically relevant.
Interventions
DRUGCélulas mesenquimales troncales alogénicas de tejido adiposo expandidas.
Sponsors
Grupo Dermatologico Y Estetico Pedro Jaen S.A.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of procedure-related adverse events occurring throughout the study., Proportion of adverse events related to allogeneic adipose tissue-derived mesenchymal stem cell infusion occurred throughout the study., Proportion of patients with major adverse cerebral and cardiovascular events (MACCE) within 12 months after treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction of the size of the aneurysm sac in the imaging tests performed during follow-up (CT and Doppler echo). A reduction in the maximum diameter of the aneurysm sac greater than or equal to 5mm in a period of 6 months is considered significant., Percentage of patients with stent migration compared to the historical cohort., Percentage of patients with presence of leaks on control CT at 1 month and 1 year compared to the historical cohort., Reoperation rate at 1 year compared to historical cohort., Hospital admission rate compared to the historical cohort., Assessment of change in quality of life: specific quality of life assessment survey at one month and one year after treatment with respect to baseline. A 10% change in quality of life scores is considered clinically relevant. | — |
Countries
Spain
Outcome results
None listed