Safety and Efficacy of Aortic Root Reinforcement Combined With Vascular Grafts Eversion and built-in Procedure (XJ-procedure) in Patients With Acute Type A Aortic Dissection (ADVANCED-XJ )

Type A Aortic Dissection Clinical Trial

Official title:
Safety and Efficacy of Aortic Root Reinforcement Combined With Vascular Grafts Eversion and built-in Procedure (XJ-procedure) in Patients With Acute Type A Aortic Dissection (ADVANCED-XJ ): an Investigator-initiated, Single-center, Cohort Study

Status Completed

Clinical Trial Summary

This is a retrospective study based on the data available in our hospital database for ATAAD patients from January 2020 to December 2021. These patients were divided into two groups according to the surgical procedures of aortic root. This study compared baseline data, perioperative and short-term follow-up results between the two groups to evaluate the efficacy and safety of XJ-procedure in ATAAD.

Clinical Trial Description

Acute type A aortic dissection (ATAAD) is a life-threatening disease with high mortality. Surgery remains the gold standard for the treatment of ATAAD. In recent years, ATAAD is still a persistent challenge for cardiovascular surgeons. This is a retrospective study based on the data available in our hospital database for ATAAD patients undergoing total aortic arch replacement with elephant trunk stent under cryogenic stop circulation from January 2020 to December 2021. These patients were divided into two groups according to the surgical procedures of aortic root: continuous aortic root suture group (CARS group); "aortic root reinforcement combined with vascular grafts eversion and built-in", which was created by our group and to be named as XJ-procedure (XJ-procedure group, XJ is an acronym for Xi'an Jiaotong University). The main outcome was defined as 30-day mortality. Secondary outcomes included the postoperative bleeding necessitating re-operation and the incidence of anastomotic pseudoaneurysm, residual aortic root dissection and severe aortic regurgitation before discharge and at 3 and 6 months after the operation. This study compared baseline data, perioperative and short-term follow-up results between the two groups to evaluate the efficacy and safety of XJ-procedure in ATAAD. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05751200
Study type	Observational
Source	First Affiliated Hospital Xi'an Jiaotong University
Contact
Status	Completed
Phase
Start date	March 1, 2023
Completion date	March 2, 2023

View Details

See also
Status	Clinical Trial	Phase
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Active, not recruiting	`NCT03369977` - BioGlue as an Adjunct for Structural Repair and Hemostasis in Chinese Acute Type A Aortic Dissections Patients	N/A
Completed	`NCT04711889` - Additive Anti-inflammatory Action for Aortopathy & Arteriopathy (Ulinastatin) II	N/A
Recruiting	`NCT03607786` - Antegrade Cerebral Perfusion and Retrograde Inferior Vena Caval Perfusion for Total Aortic Arch Replacement	N/A
Completed	`NCT06415630` - Prediction Models for Postoperative Reintubation in Patients With Acute Aortic Dissection
Enrolling by invitation	`NCT05927090` - Outcomes of Type A Aortic Dissection Repair
Completed	`NCT05346497` - Surgical Management of the Aortic Root and Long-term Outcomes For Acute Type A Aortic Dissection
Active, not recruiting	`NCT04831073` - European Registry of Type A Aortic Dissection
Recruiting	`NCT06434987` - Impact of RIVP on GI Function in Patients Undergoing Surgical Repair for ATAAD
Completed	`NCT02164201` - Post Market Surveillance Study Evaluating BioFoam Surgical Matrix in Cardiovascular Surgery	N/A
Recruiting	`NCT04032366` - iNO as Salvage Treatment of Hypoxemia After TAAD Surgery

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.