NCT05721001Active, not recruitingNot Applicable
NEO - E-vita Open Neo Treatment of Aortic Arch Aneurysms and Dissections
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- JOTEC GmbH
- Enrollment
- 130
- Locations
- 23
- Primary Endpoint
- Mortality
Study Overview
Brief Summary
Observational, prospective/retrospective, non-randomised, non-comparative, multicentre cohort study.
Primary objective is evaluation of in-hospital all-cause mortality after treatment of extensive acute and chronic aortic pathologies with E-vita OPEN NEO.
Detailed Description
Objectives
Primary objective:
• Evaluation of in-hospital all-cause mortality after treatment of extensive acute and chronic aortic pathologies with E-vita OPEN NEO
Secondary objective:
• Evaluation of the morbi-mortality in-hospital, 1 year and 3 years follow-up after treatment of extensive acute and chronic aortic pathologies with E-vita OPEN NEO.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •non-objection from the patient for data collection within this Registry
- •patient treated with E-vita Open NEO
Exclusion Criteria
- •objection from the patient for data collection within this Registry
Outcomes
Primary Outcomes
Mortality
Time Frame: through study completion, an average of 3 years
Rate of in-hospital all-cause mortality
Secondary Outcomes
- Mortality(1 year and 3 years)
- Neurological complications(At discharge, an average of 45 days, 1 year, 3 years)
- Reinterventions(1 year, 3 years)
- Severe Adverse Events(3 years)
- Stroke(At discharge, an average of 45 days, 1 year, 3 years)
- Paraplegia(At discharge, an average of 45 days, 1 year, 3 years)
- Renal Insufficiency(At discharge, an average of 45 days, 1 year, 3 years)
- Entry flow(At discharge, an average of 45 days, 1 year, 3 year)
- Morbidity(1 year and 3 year)
- Paraparesis(At discharge, an average of 45 days, 1 year, 3 years)
- Permeability(1 year, 3 years)
- Endoleaks(At discharge, an average of 45 days, 1 year, 3 years)
- Malperfusion(At discharge, an average of 45 days, 1 year, 3 years)
- Bleeding(At discharge, an average of 45 days, 1 year, 3 years)
- False Lumen(At discharge, an average of 45 days, 1 year, 3 year)
- Additional interventions(1 year, 3 year)
Investigators
Study Sites (23)
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