Safety and Efficacy of XJ-Procedure in Patients With Acute Type A Aortic Dissection Surgery
NCT ID: NCT06199401
Last Updated: 2024-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
680 participants
INTERVENTIONAL
2024-01-11
2027-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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XJ-Procedure Group
In the XJ-Procedure Group, Patients will be performed the standard "Sun's procedure" after general anesthesia, in which the end-to-end anastomosis between the artificial vessel and the aortic root is performed using the "Vascular Grafts Eversion and Built-in Technique" during the aortic root suture.
Vascular Grafts Eversion and Built-in Technique(XJ-Procedure)
A 1.5-2cm wide bovine pericardial patch and graft ring will be placed inside and outside the aortic root and against the aortic wall, respectively, and continuously sutured near the commissure using 5-0 polypropylene. Then an eversion about 15mm of vascular graft will be intermittently sutured to full layers of aortic vascular with 2-0 pad polyester suture. Finally, the eversion and aortic wall will be continuously sutured together in one more turn.
Control Group
In the Control Group, Patients will be performed the standard "Sun's procedure" which involves aortic root anastomosis using the regular technique at each cardiovascular surgery center.
No interventions assigned to this group
Interventions
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Vascular Grafts Eversion and Built-in Technique(XJ-Procedure)
A 1.5-2cm wide bovine pericardial patch and graft ring will be placed inside and outside the aortic root and against the aortic wall, respectively, and continuously sutured near the commissure using 5-0 polypropylene. Then an eversion about 15mm of vascular graft will be intermittently sutured to full layers of aortic vascular with 2-0 pad polyester suture. Finally, the eversion and aortic wall will be continuously sutured together in one more turn.
Eligibility Criteria
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Inclusion Criteria
* Patients with ATAAD attending the relevant department who have been assessed by a clinician as needing "Sun's procedure".
Exclusion Criteria
* Combined coronary artery disease requiring concomitant coronary revascularization;
* Prior aortic or cardiac surgery;
* Preoperative severe malperfusion syndromes such as: severe cerebral complications (acute cerebral infarction, cerebral hemorrhage, coma, etc.); malperfusion of abdominal organs or lower extremities \>12 h;
* Preoperative combination of severe single or multiple organ failure;
* Pregnant women;
* Refused to sign the informed consent form and refused to participate in this study.
18 Years
70 Years
ALL
No
Sponsors
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Zhejiang Provincial People's Hospital
OTHER
Second Affiliated Hospital of Nanchang University
OTHER
Qinghai People's Hospital
OTHER
First Affiliated Hospital Xi'an Jiaotong University
OTHER
Responsible Party
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Principal Investigators
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Yang Yan
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital Xi'an Jiaotong University
Guoliang Li
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital Xi'an Jiaotong University
Locations
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First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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XJTU1AF2023LSYY-006-1
Identifier Type: -
Identifier Source: org_study_id
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