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Prospective, Single-Center, Randomized Controlled Study of Hemiarch Replacement versus Total Arch Replacement for Uncomplicated Acute DeBakey Type I Aortic Dissection

Prospective, Single-Center, Randomized Controlled Study of Hemiarch Replacement versus Total Arch Replacement for Uncomplicated Acute DeBakey Type I Aortic Dissection

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114775
Enrollment
Unknown
Registered
2025-12-17
Start date
2025-12-17
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute DeBakey Type I Aortic Dissection

Interventions

hemi-arch group:Patients underwent hemi-arch replacement.
total-arch group:Patients underwent total-arch replacement.

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with acute DeBakey type I aortic dissection. 2. Patients between the ages of 18 and 70 years. 3. Patients in whom both hemiarch and total arch replacement are deemed anatomically and physiologically suitable by the operating surgeon. 4. Patients capable of understanding the trial requirements and treatment procedures, and providing written informed consent.

Exclusion criteria

Exclusion criteria: 1. Hemodynamically unstable patients requiring CPR or ECMO support. 2. History of previous open-heart surgery or thoracic endovascular aortic repair. 3. Patients with an aortic arch diameter >5.5 cm necessitating concomitant arch replacement. 4. Presence of an intimal tear or aneurysm in the aortic arch. 5. Evidence of any malperfusion (e.g., neurological deficit, mesenteric ischemia, limb ischemia). 6. Severe hepatic insufficiency (Child-Pugh class B or C, or MELD score =15). 7. Chronic renal failure (baseline eGFR <50 mL/min/1.73m²) or dialysis dependence. 8. Metastatic solid tumor or hematologic malignancy. 9. Pregnancy or lactation. 10. Diagnosis of connective tissue disease. 11. Patients deemed likely to be lost to follow-up or unwilling to comply with follow-up.

Design outcomes

Primary

MeasureTime frame
All-cause mortality;Reintervention rate;

Secondary

MeasureTime frame
Changes in the ratio of true lumen to total aortic area;

Countries

China

Contacts

Public ContactChaoyi Qin

Department of Cardiovascular Surgery and Cardiovascular Surgery Research Laboratory, West China Hospital, Sichuan University

qinchaoyi@wchscu.edu.cn+86 138 8077 5126

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026