Arch-Clamping Technique Under Mild Hypothermia in Treating With Acute Type A Aortic Dissection: Study Protocol for a Multicenter, Three-arm, Open-label, Randomized, Parallel-controlled Trail

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The study is a multicenter, three-arm, open-label, randomized, parallel-controlled trail, which plans to enroll 306 participants diagnosed with acute type A aortic dissection (ATAAD) from 7 hospitals in China. All patients receive total arch replacement (TAR) combined with frozen elephant trunk (FET) implantation and are randomized to Group 1 (arch-clamping technique under mild hypothermia), Group 2 (arch-clamping technique under moderate hypothermia) and Group 3 (Sun's procedure using bilateral antegrade cerebral perfusion) in the ratio of 1:1:1. After a 1-year follow-up, the validity and safety of the mild hypothermic arch-clamping technique for ATAAD was evaluated via the incidence of major adverse events including death, renal replacement therapy, stroke, and paraplegia, as well as times of circulatory arrest, cardiopulmonary bypass, and mechanical ventilation, and length of stay.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Aortic CTA confirmed as ATAAD according to the 2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease;

• Adult patients (18-70 years) weighing 50-120 kg;

• Time interval between the onset of symptoms and operation is less than 14 days;

• Indications for total aortic arch replacement are available;

• Signed informed consent and availability for follow-up.

Locations
Other Locations
China
Beijing Anzhen Hospital
RECRUITING
Beijing
Contact Information
Primary
Su-Wei Chen, Doctor
15524612655@163.com
+86 155 2461 2655
Time Frame
Start Date: 2025-09-05
Estimated Completion Date: 2027-11-30
Participants
Target number of participants: 306
Treatments
Experimental: Arch-clamping under mild hypothermia
TAR + FET procedure is performed using arch-clamping technique under mild hypothermia.
Experimental: Arch-clamping under moderate hypothermia
TAR + FET procedure is performed using arch-clamping technique under moderate hypothermia.
Active_comparator: Sun's procedure using bACP
Total arch replacement and frozen elephant trunk implantation with moderate hypothermic circulatory arrest.
Sponsors
Leads: Beijing Anzhen Hospital
Collaborators: Xijing Hospital,FMMU, First Affiliated Hospital Xi'an Jiaotong University, West China Hospital, Yan'an Affiliated Hospital of Kunming Medical University, Guangzhou First People's Hospital, Xiangya Hospital of Central South University

This content was sourced from clinicaltrials.gov