Interventional Enrolling by invitation
NCT05912608 on ClinicalTrials.gov
Optimal Strategy for Repair of Type A Acute Aortic Dissection
Official title: Searching Optimal Tailored Strategy for Repair of Acute Type A Acute Aortic Dissection
- Sponsor: Centre Cardiologique du Nord
- Collaborators: Henri Mondor University Hospital, Universita degli Studi di Genova, Pitié-Salpêtrière Hospital, Ospedale San Camillo, Rome, Italy
- Enrollment: 900 (Estimated)
- Study start: 2024-01-01 (Actual)
- Primary completion: 2025-06-30 (Actual)
- Study completion: 2026-12-31 (Estimated)
- Allocation: Non-Randomized
- InterventionModel: Parallel
- Masking: None
- PrimaryPurpose: Treatment
Brief Summary
Acute type A aortic dissection (TAAD) persists as a clinicopathologic entity with high lethality in the current era. Several procedures are presently used to repair the TAAAD. The objective of this study is to analyze two groups of individuals using a conservative approach through root-sparing and hemiarch techniques in patients who are hospitalized in higher-risk clinical conditions or more aggressive procedures such as root replacement and total arch replacement in low-risk patients.
Conditions
- Aortic Dissection
Intervention / Treatment
- Procedure: Conservative TAAAD-R
- Procedure: Extensive TAAAD-R
Primary Outcome Measures
-
Operative Mortality (OM)
(30-day)
Patients who died within 30 days -
Rate of Transient Neurologic Deficit (TND)
(30-day)
Number of participants who will complicate postoperatively with episode of TND which will include complication rate such as confusion, delirium, agitation -
Rate of permanent Neurologic Deficit (PND)
(30-day)
Number of participants with acute episode of a focal or global neurological deficit. Rates of alteration of degree of consciousness, hemiplegia, hemiparesis, numbness or sensory loss affecting one side of the body, dysphasia or aphasia, hemianopsia, amaurosis fugax. To consider rate of other neurologic signs or symptoms consistent with stroke duration of focal or global neurologic deficit greater than 24 hours.
Countries
France
Locations and Investigators
- Francesco Nappi, Saint-Denis, France
Study Officials
- Francesco Nappi (Principal Investigator) — Cardiac Surgery Centre Cardiologique du Nord de Saint-Denis, Paris, France