An interventional study of Vascular Grafts Eversion and Built-in Technique(XJ-Procedure) in Type A Aortic Dissection, Complication of Surgical Procedure and Aortic Diseases, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-07-12.
Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Not applicable, Interventional, and Treatment
This is a national, multicenter, open-label, randomized, controlled, endpoint-blinded clinical trial of patients diagnosed with ATAAD and undergoing "Sun's procedure" coordinated by the First Affiliated Hospital of Xi'an Jiaotong University, China. Per the protocol, "Sun's procedure" combined with "XJ-Procedure" in the anastomosis of the aortic root and Sun's procedure combined with regular suturing methods of the aortic root will be compared.
In this study, the investigators will prospectively enroll patients diagnosed with ATAAD and undergo "Sun's procedure" from November 2024 to November 2027 in several centers, including the First Affiliated Hospital of Xi'an Jiaotong University, and will randomly divide them into XJ-procedure group and control group. "The patients in the XJ-procedure group will undergo "Sun's procedure", in which the anastomosis of the aortic root will be performed with the XJ-procedure. The patients in the control group will also undergo "Sun's procedure", in which the anastomosis of the aortic root will be performed with each center. The primary outcome event is all-cause mortality within 12 months after surgery. Secondary outcome events are (1) incidence of residual aortic root entrapment (during hospitalization, follow-up 3 months, 6 months, 12 months) (2) rate of secondary surgery for hemostasis due to root hemorrhage (during hospitalization) (3) incidence of anastomotic pseudoaneurysm (during hospitalization, follow-up 3 months, 6 months, 12 months) (4) rate of severe regurgitation of residual aortic valves (during hospitalization, follow-up 3 months, 6 months, 12 months) (5) Incidence of major adverse cardiovascular and cerebrovascular events (MACCE) (during hospitalization, follow-up 3 months, 6 months, 12 months).
108 studies on the registry are indexed under Aortic Diseases; 43 are open to participants now.
This study's planned enrollment of 680 is above the median of 90 across 42 interventional studies indexed under Aortic Diseases.
Browse Aortic Diseases studies →First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 314 studies on the registry; 87 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Vascular Grafts Eversion and Built-in Technique(XJ-Procedure)
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.
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.
All-cause mortality
This outcome is a time-to-event variable and its data will be obtained at 12 months follow-up, according to the medical records or phone calls of all patients.
Time frame: 12 months follow-up
Change of incidence of residual aortic root dissection
The data will be obtained during hospitalization, at the 3 months, 6 months, and 12 months follow-up, according to CTA and echocardiography results of all patients.
Time frame: About 20 days (during hospitalization), at the 3 months, 6 months, and 12 months follow-up
Change of incidence of second surgery for hemostasis due to aortic root hemorrhage
The data will be obtained during hospitalization, according to medical records of all patients.
Time frame: About 20 days (during hospitalization)
Change of incidence of anastomotic pseudoaneurysms during hospitalization
The data will be obtained during hospitalization at the 3 months, 6 months, and 12 months follow-up, according to CTA and echocardiography results of all patients.
Time frame: About 20 days (during hospitalization), at the 3 months, 6 months, and 12 months follow-up
Change of incidence of severe residual aortic valve regurgitation
The data will be obtained during hospitalization, at the 3 months, 6 months, and 12 months follow-up, according to the echocardiography results of all patients.
Time frame: About 20 days (during hospitalization), at the 3 months, 6 months, and 12 months follow-up
Change of incidence of MACCE
MACCE includes all-cause of death, myocardial infarction, stroke and coronary revascularization. The data will be obtained during hospitalization, at the 3 months, 6 months, and 12 months follow-up, according to medical records and imaging findings of all patients.
Time frame: About 20 days (during hospitalization), at the 3 months,6 months, and 12 months follow-up
Started Jan 2024 (actual). Primary completion is estimated for Mar 2027, 37 months after the start.
Of 21 interventional studies with no phase under Aortic Diseases, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 107. This study's planned 37 months is above that.
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