Study Comparing Hemiarch Replacement and Hemiarch Plus Stent Implantation in Acute Aortic Dissection
Randomized Trial on Acutely Dissected Aorta Repair With Hemiarch Replacement With or Without Stent Implantation (RADAR Trial)
Chinese University of Hong Kong
72 participants
Oct 1, 2023
INTERVENTIONAL
Conditions
Summary
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 hybrid prosthesis with a proximal sewing collar and distal nitinol self-expanding un-covered stent system designed to reduce the occurrence of DANE and hopefully depressurize the false lumen and lead to remodeling of the aortic wall. The investigators plan to prospectively recruit consecutive patients with acute ascending thoracic aortic dissection patients (Excluding DeBakey II) and randomized them, after informed consent, into either the conventional hemiarch replacement group (Hemiarch-C) or the hemiarch replacement plus AMDS implantation group (Hemiarch-AMDS). The participating team will collect pre-operative, intra-operative and post-operative clinical and radiological parameters for two groups of patients. Written informed consent, specifically allowing the use of clinical records for this randomized study, will be obtained from every patient prior to data collection. Complete DICOM image files of the CT scans will be evaluated by two independent fully qualified Radiologists. Our primary outcome is the radiological detection of DANE in Hemiarch-C and Hemiarch-AMDS groups within the 12-month follow-up period. This study will be the world's first randomized control trial in ATAD to compare the prevalence of DANE in Hemiarch-C and Hemiarch-AMDS. It could be a guideline-changing study for the treatment of ATAD and its impact on the immediate survival, second-stage treatment, and long-term survival of patients suffering from ATAD.
Eligibility
Inclusion Criteria4
- Patient´s age is between 18 and 80 years.
- Patient is willing and able to give informed consent.
- Patient has acute DeBakey Type I and requires repair or replacement of damaged or diseased vessels of the ascending aorta.
- Patient not in coma/irreversible end organ failure/cardiac massage for resuscitation, at the time of consent.
Exclusion Criteria6
- Patient has aortic arch diameter of more than 4.5 cm
- Patient has known connective tissue disease or genetically linked aortopathy
- Patient has entry tear more than 2 cm over aortic arch
- Patient with DeBakey Type II aortic dissection
- Patient has co-morbidity (i.e. active malignancy (progressive, stable or partial remission)) causing expected survival to be less than 2 years.
- 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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Interventions
Ascyrus Medical Dissection Stent (AMDS; Artivion, Atlanta, Georgia, US) hybrid prosthesis which comprises a proximal sewing collar and a distal self-expanding nitinol un-covered stent.
Coventional open hemiarch replacement
Locations(1)
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NCT06044259