NCT06492980 A Triple-branched Stent Graft for Aute Debakey Type I Dissection Surgery
| NCT ID | NCT06492980 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fujian Medical University |
| Condition | Acute Aortic Dissection |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2023-10-27 |
| Primary Completion | 2024-10-10 |
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 150 participants in total. It began in 2023-10-27 with a primary completion date of 2024-10-10.
⚠ 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
Prospective, multicenter, randomized controlled clinical trial plan to evaluate the effectiveness and safety of intraoperative stent system in the treatment of acute type I aortic dissection
Eligibility Criteria
Inclusion Criteria: 1. Patients with acute type I aortic dissection who need arch repair; 2. Aged ≥20 years and ≤65 years; 3. Acute phase, with onset within 14 days before surgery; 4. Subjects who can understand the purpose of the trial, voluntarily participate and sign the informed consent form, and are willing to accept follow-up. Exclusion Criteria: 1. The presence of anatomical variations, such as aortic arch malformation, aortic coarctation; common origin of the innominate artery and the left common carotid artery, aberrant right subclavian artery, abnormal origin of the left conical artery, stenosis or distortion of the branch arteries; and the diameter of the aortic arch and branch artery diameters do not match the specifications of the test device; 2. Dissection is secondary to a history of aortic treatment, Marfan syndrome, etc. 3. Aortic lesions and branch artery lesions caused by acute type I aortic dissection, including aortic pre-rupture, branch artery rupture, branch artery occlusion, and severe ischemic complications caused by poor organ perfusion, such as myocardial ischemia, stroke (ischemic brain injury), paraplegia (spinal artery ischemia), mesenteric artery ischemia, renal artery dysplasia, etc. 4. Severe infectious lesions that are not controlled; 5. Patients who need to receive other concomitant treatments, such as severe hypertension, chronic obstructive pulmonary disease, coronary heart disease, chronic kidney disease and other serious underlying lesions that require long-term treatment; 6. Patients with other life-threatening lesions, such as advanced malignant tumors, and whose expected survival time is less than one year; 7. Patients with other lesions in the heart and aorta (patients with other heart diseases that require concurrent heart surgery, such as coronary heart disease, mitral valve disease, tricuspid valve disease, etc.), who are not suitable for stent interventional treatment, such as peripheral vascular disease and blood disease; 8. Subjects who have participated in other drug or device clinical trials and have not reached the primary study endpoint; and pregnant women.
Contact & Investigator
Liang-wan Chen, M.D Ph.D
STUDY CHAIR
Fujian Medical University Union Hospital
Frequently Asked Questions
Who can join the NCT06492980 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 65 Years, studying Acute 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 NCT06492980 currently recruiting?
Yes, NCT06492980 is actively recruiting participants. Contact the research team at chenliangwan@tom.com for enrollment information.
Where is the NCT06492980 trial being conducted?
This trial is being conducted at Fuzhou, China.
Who is sponsoring the NCT06492980 clinical trial?
NCT06492980 is sponsored by Fujian Medical University. The principal investigator is Liang-wan Chen, M.D Ph.D at Fujian Medical University Union Hospital. The trial plans to enroll 150 participants.