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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2027-10-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Type a Aortic Dissection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomized, double-blind, parallel-group, non-inferiority trial. Participants are assigned 1:1 to receive either Ascending Aorta with Hemiarch Replacement or Ascending Aorta with Total Arch and Frozen Elephant Trunk Replacement.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Participant Blinding: The patient will not be informed of whether they received a hemiarch or total arch replacement procedure. This is maintained through consistent post-operative communication that does not disclose the specific surgical technique.

Outcome Assessor Blinding: The members of the independent imaging core laboratory, who are responsible for evaluating the primary endpoint (post-operative CTA scans for false lumen patency), are blinded to the patient's group assignment. All identifying information and surgical details related to the group allocation are removed from the images before analysis.

Care Provider (Surgeon) Blinding: The operating surgeons cannot be blinded due to the nature of the surgical interventions.

Study Groups

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Ascending Aorta / Hemiarch Replacement Group

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.

Group Type EXPERIMENTAL

Ascending Aorta / Hemiarch Replacement

Intervention Type PROCEDURE

This procedure involves the replacement of the ascending aorta and the proximal portion of the aortic arch (hemiarch). The distal aortic arch and the origins of the supra-aortic vessels (brachiocephalic trunk, left common carotid artery, and left subclavian artery) are preserved. It does not involve the implantation of a stent graft into the descending aorta.

Total Arch Replacement and Frozen Elephant Trunk Replacement Group

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.

Group Type ACTIVE_COMPARATOR

Total Arch Replacement and Frozen Elephant Trunk Replacement.

Intervention Type PROCEDURE

This procedure involves the replacement of the entire aortic arch, combined with the implantation of a frozen elephant trunk (FET) stent graft into the proximal descending aorta. The arch vessels are typically re-implanted as a single branch island patch or individually. The procedure includes total resection of the arch and aims to promote false lumen thrombosis in the proximal descending aorta.

Interventions

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Ascending Aorta / Hemiarch Replacement

This procedure involves the replacement of the ascending aorta and the proximal portion of the aortic arch (hemiarch). The distal aortic arch and the origins of the supra-aortic vessels (brachiocephalic trunk, left common carotid artery, and left subclavian artery) are preserved. It does not involve the implantation of a stent graft into the descending aorta.

Intervention Type PROCEDURE

Total Arch Replacement and Frozen Elephant Trunk Replacement.

This procedure involves the replacement of the entire aortic arch, combined with the implantation of a frozen elephant trunk (FET) stent graft into the proximal descending aorta. The arch vessels are typically re-implanted as a single branch island patch or individually. The procedure includes total resection of the arch and aims to promote false lumen thrombosis in the proximal descending aorta.

Intervention Type PROCEDURE

Other Intervention Names

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Partial Arch Replacement Total Arch Replacement with FET

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes