NCT06541106 Registry of Endovascular Treatment for Vertebrobasilar Dissecting Aneurysms in China
| NCT ID | NCT06541106 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Tiantan Hospital |
| Condition | Dissecting Aneurysm of Cerebral Artery |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2011-01-01 |
| Primary Completion | 2031-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2011-01-01 with a primary completion date of 2031-01-01.
⚠ 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
The incidence of vertebrobasilar dissecting aneurysms (VBDAs) is about 1/100,000\~1.5/100,000, and it is one of the most important causes of stroke in young and middle-aged people. In recent years, with the development of medical imaging technology, the detection rate of this disease has been increasing year by year. The natural prognosis of VBDAs is complex and varied, with uncertainty: (1) it may have a benign course, and the imaging follow-up may show that the diseased vessels are repaired and improved or remain stable for a long period of time; (2) it may present with ischemic stroke caused by hemodynamic alteration or thromboembolism, which may result in severe neurological impairment; (3) it may occur as a result of rupture of aneurysms leading to subarachnoid hemorrhage, endangering the patient's life; (4) progressive enlargement of VBDAs causing occupying effects, which may be manifested as headache in mild cases, or hemiplegia of limbs and choking on drinking water in severe cases. Up to now, there is a lack of objective and uniform diagnostic and therapeutic guidelines for the natural regression of VBDAs and the benefits of surgery, and the treatment is mostly empirical, which makes it difficult to accurately determine the clinical prognosis of VBDAs and formulate appropriate treatment strategies. Therefore, against the above background, we designed the present study. This study was a multicenter, prospective, registry study. We enrolled patients with unruptured VBDAs who met the inclusion and exclusion criteria, and a multi-disciplinary team formulated the treatment modalities for the patients, which were categorized into the conservative observation group, the stent-assisted coiling group, and the flow diverter group. The aim of our study was to investigate the effects of different treatment modalities on the prognosis of patients with VBDAs, as well as to stratify the risk factors of the patients, to explore the individualized treatment modalities of the patients, and to improve the diagnosis and treatment of this clinically refractory cerebrovascular disease.
Eligibility Criteria
Inclusion Criteria: 1. Age 18-80 years old; 2. Patients diagnosis of "unruptured vertebrobasilar dissecting aneurysm". Exclusion Criteria: 1. Patients did not undergo a cranial MRI; 2. Missing critical clinical baseline; 3. Missing pre-treatment imaging; 4. Receiving microsurgery; 5. The combination of other serious diseases during diagnosis will significantly affect the follow-up of patients; 6. CT/MRI shows intracranial hemorrhage or subarachnoid hemorrhage (SWI microbleeds are ignored).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06541106 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Dissecting Aneurysm of Cerebral Artery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06541106 currently recruiting?
Yes, NCT06541106 is actively recruiting participants. Contact the research team at donglinggen@163.com for enrollment information.
Where is the NCT06541106 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06541106 clinical trial?
NCT06541106 is sponsored by Beijing Tiantan Hospital. The trial plans to enroll 2,000 participants.