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Study Comparing Hemiarch Replacement and Hemiarch Plus Stent Implantation in Acute Aortic Dissection

RecruitingNAAges 18 Years - 80 YearsAllChinese University of Hong Kong
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In plain words

What the trial is, and whether it could suit you

Acute DeBakey type I aortic dissection (ATAD) is one of the most lethal surgical emergencies. The conventional operative strategy is hemiarch replacement under cardiopulmonary bypass support to replace the diseased segment of the ascending aorta. However, in patients with dissection involving the whole aortic arch and descending thoracic aorta, the presence of the persistently perfused false lumen can lead to late aneurysm formation and require a second-stage operation, and this reduces long-term survival. In the surgical literature, there is growing evidence that the presence of Distal Anastomosis New Entry (DANE), which is a new intimal defect related to the trauma created by surgical sutures, is associated with persistent perfusion of the false lumen, aortic size growth, and the need of re-operation. The Ascyrus Medical Dissection Stent (AMDS; Artivion, Atlanta, Georgia, USA) is a hyb

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • AMDS; Artivion, Atlanta, Georgia, US
  • Conventional hemiarch replacement
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Where

1 site
Prince of Wales Hospital
Hong Kong, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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