Hemiarch vs. Total Arch With FET for Type A Aortic IMH

Jilin University

Status: Not yet enrolling

Conditions: Type a Aortic Dissection

Treatments: Procedure: Total Arch Replacement and Frozen Elephant Trunk Replacement.; Procedure: Ascending Aorta / Hemiarch Replacement

Study type: Interventional

Funder types: Other

Identifiers

NCT07272655

JDEYXWK305

Details and patient eligibility

About

This is a prospective, randomized, double-blind, non-inferiority clinical trial designed to compare the efficacy and safety of two surgical strategies for Type A aortic intramural hematoma (TAIMH): (1) Ascending aorta /hemiarch replacement (A/HAR), and (2) Ascending aorta with total arch replacement and frozen elephant trunk (TARFET).

Patients with acute TAIMH will be enrolled based on computed tomography angiography (CTA) confirmation of a completely thrombosed false lumen in the ascending aorta and aortic arch. Eligible participants will be randomly assigned in a 1:1 ratio to either the A/HAR group (experimental) or the TARFET group (active comparator).

The primary endpoint is the rate of perioperative false lumen patency in the aortic arch and descending aorta, assessed postoperatively by a blinded, independent imaging core laboratory using CTA. Secondary endpoints include the aortic cross-clamp time, circulatory arrest time, total operation time, aortic reintervention rate, and perioperative complications, rate of false lumen patency in the aortic arch and descending aorta at 6 - 12 months.

The study tests the non-inferiority hypothesis that the less extensive A/HAR strategy is not inferior to the more extensive TARFET strategy in preventing early false lumen patency, while also exploring its potential superiority regarding other operative outcomes, such as reduced procedure times and lower incidence of complications. A total of 300 participants will be enrolled to ensure adequate statistical power. The findings from this trial are expected to provide high-quality evidence to guide optimal surgical strategies for patients with this unique aortic pathology.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years and ≤ 80 years.
2. Diagnosis of type A aortic intramural hematoma (TAIMH).
3. Ability to understand the study procedure and provide written informed consent.

Exclusion criteria

1. Preoperative CTA shows an open or partially thrombosed (mixed) false lumen in the ascending aorta or arch.
2. Primary tear located on the greater curvature of the aortic arch, necessitating total arch replacement.
3. Planned concomitant major cardiac surgery (e.g., CABG, valve replacement, atrial fibrillation ablation).
4. Previous history of aortic arch or distal aortic surgery.
5. Severe peripheral vascular disease or cerebrovascular anatomy abnormality.
6. Active systemic infection, malignancy, severe hepatic or renal dysfunction, or other major comorbidities with life expectancy < 1 year or deemed unfit for complex cardiovascular surgery.
7. Pregnancy or lactation.
8. Severe psychiatric or cognitive disorders affecting compliance or follow-up.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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250 participants in 2 patient groups

Ascending Aorta / Hemiarch Replacement Group

Experimental group

Description:

Participants randomized to this group will undergo Ascending Aorta and hemiarch replacement surgery. The procedure involves replacing the ascending aorta and the proximal portion of the aortic arch , while preserving the distal arch and supra-aortic vessels.

Treatment:

Procedure: Ascending Aorta / Hemiarch Replacement

Total Arch Replacement and Frozen Elephant Trunk Replacement Group

Active Comparator group

Description:

Participants randomized to this group will undergo conventional aortic total arch replacement surgery. This typically involves replacing the entire aortic arch , often combined with a frozen elephant trunk procedure into the descending aorta.

Treatment:

Procedure: Total Arch Replacement and Frozen Elephant Trunk Replacement.