NCT06044259 Study Comparing Hemiarch Replacement and Hemiarch Plus Stent Implantation in Acute Aortic Dissection
| NCT ID | NCT06044259 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese University of Hong Kong |
| Condition | Aortic Dissection |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2023-10-01 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 72 participants in total. It began in 2023-10-01 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06044259 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Aortic Dissection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06044259 currently recruiting?
Yes, NCT06044259 is actively recruiting participants. Contact the research team at wonhl1@surgery.cuhk.edu.hk for enrollment information.
Where is the NCT06044259 trial being conducted?
This trial is being conducted at Hong Kong, China.
Who is sponsoring the NCT06044259 clinical trial?
NCT06044259 is sponsored by Chinese University of Hong Kong. The trial plans to enroll 72 participants.