Hybrid vs. Conventional Surgery for Type A Aortic Dissection

NCT ID: NCT07107711

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2023-03-30

Brief Summary

This is a prospective, randomized controlled trial designed to compare the clinical efficacy and short-term outcomes of one-stop hybrid surgery versus conventional total arch replacement with frozen elephant trunk (FET) in patients with acute Stanford Type A Aortic Dissection. The study evaluates differences in perioperative metrics, postoperative complications, 30-day survival, aortic remodeling, and quality of life.

Detailed Description

Stanford Type A Aortic Dissection (TAAD) is a life-threatening condition requiring urgent surgical repair. This study tests the hypothesis that a one-stop hybrid surgery protocol is superior to conventional repair. 140 patients with acute TAAD were randomized to one of two groups. The experimental group received a one-stop hybrid surgery, which combines open total arch replacement using a standard branched surgical graft with the antegrade deployment of a separate stent graft, performed under moderate hypothermia. The active comparator group underwent conventional total arch replacement using an integrated frozen elephant trunk (FET) hybrid prosthesis, performed under deep hypothermic circulatory arrest. The study's main objective is to compare key clinical outcomes between the two surgical strategies, including a primary composite endpoint of 30-day mortality, stroke, and acute kidney injury, to provide evidence on the optimal surgical approach for this high-risk population.

Conditions

Acute Stanford Type A Aortic Dissection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: Hybrid Group (n=70)

Patients were randomized to undergo one-stop hybrid surgery, which included total aortic arch replacement with a standard 4-branched artificial vascular graft combined with antegrade stent grafting of the proximal descending aorta, performed in a single stage under moderate hypothermia (approx. 28°C).

Group Type: EXPERIMENTAL

One-Stop Hybrid Surgery

Intervention Type: PROCEDURE

With the patient under moderate hypothermia (approx. 28°C) and cardiopulmonary bypass, surgeons perform a total arch replacement using a standard 4-branched graft. After the open repair is complete, a separate, distinct covered stent graft is deployed antegradely into the descending aorta through the open distal end of the arch graft. Completion angiography confirms correct placement.

Active Comparator: Conventional Group (n=70)

Patients were randomized to undergo conventional total arch replacement using an integrated frozen elephant trunk (FET) hybrid prosthesis. The procedure was performed under deep hypothermic circulatory arrest (target temperature 23°C-25°C).

Group Type: ACTIVE_COMPARATOR

Conventional Total Arch Replacement with Frozen Elephant Trunk

Intervention Type: PROCEDURE

With the patient under deep hypothermic circulatory arrest (23°C-25°C) and cardiopulmonary bypass, surgeons perform a total arch replacement using an integrated hybrid prosthesis (Frozen Elephant Trunk), which consists of a vascular graft sutured to a covered stent graft. This single device is deployed antegradely into the descending aorta, and the arch vessels are then reattached to the branches of the prosthetic graft.

Interventions

One-Stop Hybrid Surgery

With the patient under moderate hypothermia (approx. 28°C) and cardiopulmonary bypass, surgeons perform a total arch replacement using a standard 4-branched graft. After the open repair is complete, a separate, distinct covered stent graft is deployed antegradely into the descending aorta through the open distal end of the arch graft. Completion angiography confirms correct placement.

Intervention Type: PROCEDURE

Conventional Total Arch Replacement with Frozen Elephant Trunk

With the patient under deep hypothermic circulatory arrest (23°C-25°C) and cardiopulmonary bypass, surgeons perform a total arch replacement using an integrated hybrid prosthesis (Frozen Elephant Trunk), which consists of a vascular graft sutured to a covered stent graft. This single device is deployed antegradely into the descending aorta, and the arch vessels are then reattached to the branches of the prosthetic graft.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age 18-70 years.
• Diagnosis of acute TAAD (symptom onset <72 hours) confirmed by imaging, with dissection involving the aortic arch requiring total arch replacement.
• Relative hemodynamic stability, defined as a systolic blood pressure >90 mmHg without high-dose vasopressor support (norepinephrine >0.1 µg/kg/min).
• Provision of informed consent.

Exclusion Criteria

• Age >70 years.
• Stanford type B or non-dissection pathologies.
• Life-threatening comorbidities prohibitive of major cardiac surgery (e.g., advanced multiorgan failure from other causes, active malignancy).
• Absolute contraindications to surgery.
• History of previous ascending aorta or aortic arch surgery.
• Inability to provide informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Hospital of Hebei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Qi Hu

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Countries

China

Other Identifiers

2020139

Identifier Type: -

Identifier Source: org_study_id