Evaluating a new surgical technique for patients with acute type A aortic dissection
Safety and Efficacy of XJ-Procedure in Patients With Acute Type A Aortic Dissection Surgery (ADVANCED-XJ-Ⅱ): A National, Multi-center, Open-label, Randomized, Controlled, Blinded-end Point Trial
NA · First Affiliated Hospital Xi'an Jiaotong University · NCT06199401
This study is testing a new surgical method for people with acute type A aortic dissection to see if it is safer and more effective than the standard technique.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 680 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital Xi'an Jiaotong University (other) |
| Locations | 1 site (Xi'an, Shaanxi) |
| Trial ID | NCT06199401 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a national, multicenter, open-label, randomized, controlled trial aimed at assessing the safety and efficacy of the XJ-Procedure in patients diagnosed with acute type A aortic dissection (ATAAD) undergoing 'Sun's procedure'. Participants will be randomly assigned to either the XJ-procedure group, where the aortic root anastomosis will be performed using the new technique, or the control group, which will use standard suturing methods. The primary outcome will measure all-cause mortality within 12 months post-surgery, while secondary outcomes will evaluate various complications and adverse events during hospitalization and follow-up periods. The trial is set to enroll patients from November 2024 to November 2027 across multiple centers in China.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-70 years diagnosed with acute type A aortic dissection who require 'Sun's procedure'.
Not a fit: Patients with severe aortic root involvement, prior cardiac surgeries, or significant organ failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients undergoing surgery for acute type A aortic dissection.
How similar studies have performed: While this approach is novel, similar surgical techniques have shown promise in improving outcomes in cardiovascular surgeries.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Xi'an, Shaanxi
- First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shaanxi, China (RECRUITING)
Study contacts
- Principal investigator: Yang Yan — First Affiliated Hospital Xi'an Jiaotong University
- Study coordinator: Yang Yan
- Email: yangyan3@xjtu.edu.cn
- Phone: +86.29.85323869
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type A Aortic Dissection, Complication of Surgical Procedure, Aortic Diseases, Aortic Root Reinforcement, Cardiovascular Surgery, Postoperative Complication