Comparing two surgical methods for treating acute aortic dissection
Randomized Trial on Acutely Dissected Aorta Repair With Hemiarch Replacement With or Without Stent Implantation (RADAR Trial)
NA · Chinese University of Hong Kong · NCT06044259
This study is testing two different surgical methods for treating a serious type of aortic dissection to see which one helps patients recover better and have fewer complications.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Chinese University of Hong Kong (other) |
| Locations | 1 site (Hong Kong, Hong Kong) |
| Trial ID | NCT06044259 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with acute DeBakey Type I aortic dissection requiring surgical intervention.
Not a fit: Patients with significant aortic arch dilation, connective tissue diseases, or other severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients with acute aortic dissection.
How similar studies have performed: While there is growing evidence supporting the use of hybrid prostheses in similar cases, this specific comparison of techniques is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 more than 2 cm 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 this trial is running
Hong Kong, Hong Kong
- Prince of Wales Hospital — Hong Kong, Hong Kong, China (RECRUITING)
Study contacts
- Study coordinator: Randolph Wong
- Email: wonhl1@surgery.cuhk.edu.hk
- Phone: +85255699431
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Aortic Dissection, Hemiarch replacement, AMDS implantation