Evaluating a new surgical technique for patients with acute type A aortic dissection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.