Status:

RECRUITING

Safety and Efficacy of XJ-Procedure in Patients With Acute Type A Aortic Dissection Surgery

Lead Sponsor:

First Affiliated Hospital Xi'an Jiaotong University

Collaborating Sponsors:

Zhejiang Provincial People's Hospital

Second Affiliated Hospital of Nanchang University

Conditions:

Type A Aortic Dissection

Complication of Surgical Procedure

Eligibility:

All Genders

18-70 years

Phase:

NA

Brief 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 Affiliat...

Detailed 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 Affil...

Eligibility Criteria

Inclusion

  • Age 18-70 years;
  • Patients with ATAAD attending the relevant department who have been assessed by a clinician as needing "Sun's procedure".

Exclusion

  • 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.

Key Trial Info

Start Date :

January 11 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2027

Estimated Enrollment :

680 Patients enrolled

Trial Details

Trial ID

NCT06199401

Start Date

January 11 2024

End Date

December 1 2027

Last Update

July 12 2024

Active Locations (1)

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First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China, 710061