Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06199401
Other study ID # XJTU1AF-CRF-2023-XK006
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 1, 2024
Est. completion date December 1, 2027

Study information

Verified date April 2024
Source First Affiliated Hospital Xi'an Jiaotong University
Contact Yang Yan
Phone +86.29.85323869
Email yangyan3@xjtu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 680
Est. completion date December 1, 2027
Est. primary completion date March 1, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Age 18-70 years; - Patients with ATAAD attending the relevant department who have been assessed by a clinician as needing "Sun's procedure". Exclusion Criteria: - Severe aortic root involvement (root diameter >45 mm, root tear, severe destruction of the aortic root, combined valve disease); - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
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.

Locations

Country Name City State
China First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shaanxi

Sponsors (4)

Lead Sponsor Collaborator
First Affiliated Hospital Xi'an Jiaotong University Qinghai People's Hospital, Second Affiliated Hospital of Nanchang University, Zhejiang Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 12 months follow-up
Secondary 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. About 20 days (during hospitalization), at the 3 months, 6 months, and 12 months follow-up
Secondary 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. About 20 days (during hospitalization)
Secondary 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. About 20 days (during hospitalization), at the 3 months, 6 months, and 12 months follow-up
Secondary 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. About 20 days (during hospitalization), at the 3 months, 6 months, and 12 months follow-up
Secondary 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. About 20 days (during hospitalization), at the 3 months,6 months, and 12 months follow-up
See also
  Status Clinical Trial Phase
Recruiting NCT02789579 - The Preventive Infection Role of One Week Antibiotics Before Minimally Invasive Upper Tract Lithotomy Early Phase 1
Withdrawn NCT02374294 - TCOT Effectiveness in Preventing Wound Infections in Perineal Resections Phase 2
Completed NCT02252562 - Hand Hygiene and Hospital Acquired Infections N/A
Completed NCT01757704 - Factors Responsible for the Effectiveness of the Lund De-airing Technique N/A
Recruiting NCT05005117 - Laparoscopic Approach for Emergency Colon Resection N/A
Enrolling by invitation NCT03234543 - Remote Ischemic Conditioning in Abdominal Surgery N/A
Completed NCT04849702 - Comparison of the Clavien-Dindo and Comprehensive Complication Index
Completed NCT04120324 - Incidence of 30 Day Return to Hospital Following Same Day Discharge Total Hip Arthroplasty
Recruiting NCT05761821 - Key Factors of Leadless Pacemaker Implantation With Implantation Site, Complications and Prognosis
Active, not recruiting NCT05795127 - Risk for Reoperation After First MTP Joint Arthrodesis
Completed NCT04550156 - Evaluation of the Introduction of a Colorectal Bundle in Left Sided Colorectal Resections N/A
Recruiting NCT05194943 - Trends and Safety in Revisional Bariatric Surgery in Italy
Not yet recruiting NCT03313986 - Outcomes of Surgical Correction of Penile Curvature in Adult N/A
Enrolling by invitation NCT04456530 - Use of Testosterone to Prevent Post-Surgical Muscle Loss - Pilot Study Phase 2/Phase 3
Completed NCT03125798 - Comparison of LigaSure to Conventional Electrocoagulation in Video-assisted Thoracoscopic Surgery Lobectomy N/A
Completed NCT04226482 - Review of Efficacy of Used ultraSonic Energy Device N/A
Completed NCT01739374 - Efficacy and Safety of Reduced Pelvic Floor Mesh Implants Phase 2/Phase 3
Completed NCT01346709 - Prospective Evaluation of a RIsk Score for Postoperative Pulmonary COmPlications in Europe
Enrolling by invitation NCT06394908 - Registry of MIUS for Urolithiasis (ReMIUS-U)
Recruiting NCT02212054 - A Trial on Treatments of Hirschsprung Allied Disease N/A