CTIS2022-501935-18-00RecruitingPhase 1
Abdominal Aortic Aneurysm Stabilization with Truncal Cells: Controlled Clinical Trial with Historical Cohorts. - HULP-STEM-EVAR-2020
Grupo Dermatologico Y Estetico Pedro Jaen S.A.0 sites8 target enrollmentStarted: November 7, 2023Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 8
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 65+ (—)
- Sex
- All
Inclusion Criteria
- •Subjects with AAA greater than 5 cm in diameter with indication for endovascular treatment, analyzed by aortic AngioCT., Subjects = 18 years of age at the time of inclusion., Subjects with a good infrarenal neck for placement of a standard device, neither fenestrated nor branched., Patients with an estimated life expectancy greater than two years at inclusion., Women of childbearing potential must have a negative pregnancy test at inclusion and must agree to use highly effective contraceptive methods (diaphragms plus spermicide or male condom plus spermicide, oral contraceptive combined with a second method contraceptive implant, injectable contraceptive, permanent intrauterine device, sexual abstinence or partner with vasectomy) during their participation in the study., The patient must be able to attend all study visits and abide by all study procedures.
Exclusion Criteria
- •Patients with a history of unresolved neoplasm or hematologic disease., Administration of any investigational drug at the time of inclusion or in the three months prior., Women who are breastfeeding or pregnant women., Transplanted patients., Patients with uncontrolled arterial hypertension (=180/110) at inclusion., Patients with severe heart failure (New York Heart Association [NYHA] IV) or ejection fraction <20%., Patients with malignant ventricular arrhythmias., Patients with deep vein thrombosis in the last three months., Patient with active septic picture at the time of inclusion., Patients with acute myocardial infarction or stroke the previous month., Medical or psychiatric illness of any kind that, in the opinion of the investigator, may be a reason for exclusion from the study., Patient with major surgery or severe craniocerebral trauma in the 3 months prior to inclusion in the study.
Investigators
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