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

NCT06199401 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 680

Last updated 2024-07-12

No results posted yet for this study

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.

Conditions

  • Type A Aortic Dissection
  • Complication of Surgical Procedure
  • Aortic Diseases

Interventions

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.

Sponsors & Collaborators

  • Zhejiang Provincial People's Hospital

    collaborator OTHER

  • Second Affiliated Hospital of Nanchang University

    collaborator OTHER

  • Qinghai People's Hospital

    collaborator OTHER

  • First Affiliated Hospital Xi'an Jiaotong University

    lead OTHER

Principal Investigators

  • Yang Yan · First Affiliated Hospital Xi'an Jiaotong University

  • Guoliang Li · First Affiliated Hospital Xi'an Jiaotong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-11
Primary Completion
2027-03-01
Completion
2027-12-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06199401 on ClinicalTrials.gov