Comparing two surgical methods for treating acute aortic dissection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare the outcomes of two surgical approaches for patients with acute DeBakey Type I aortic dissection: conventional hemiarch replacement and hemiarch replacement combined with the Ascyrus Medical Dissection Stent (AMDS). The primary objectives include assessing the occurrence of new intimal defects, rates of mortality, and major adverse events over a follow-up period. Additionally, the study will evaluate radiological outcomes related to aortic health in both treatment groups. The research is conducted at the Prince of Wales Hospital in Hong Kong.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patient´s age is between 18 and 80 years.
2. Patient is willing and able to give informed consent.
3. Patient has acute DeBakey Type I and requires repair or replacement of damaged or diseased vessels of the ascending aorta.
4. Patient not in coma/irreversible end organ failure/cardiac massage for resuscitation, at the time of consent.

Exclusion Criteria:

1. Patient has aortic arch diameter of more than 4.5 cm
2. Patient has known connective tissue disease or genetically linked aortopathy
3. Patient has entry tear over aortic arch
4. Patient with DeBakey Type II aortic dissection
5. Patient has co-morbidity (i.e. active malignancy (progressive, stable or partial remission)) causing expected survival to be less than 2 years.
6. Patient has any other medical, social, or psychological problems, that in the opinion of the investigator, preclude the patient from participating in this study.

Where it's running

• Prince of Wales Hospital
  Hong Kong, Hong Kong, China Recruiting

Study contacts

• Study coordinator: Randolph Wong
• Email: wonhl1@surgery.cuhk.edu.hk
• Phone: +85255699431

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.