An observational study in Dissecting Aneurysm of Cerebral Artery, sponsored by Beijing Tiantan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-11-28.
Sponsored by Beijing Tiantan Hospital · Observational
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.
214 studies on the registry are indexed under Hemorrhagic Stroke; 84 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 300 across 64 observational studies indexed under Hemorrhagic Stroke.
Browse Hemorrhagic Stroke studies →Beijing Tiantan Hospital is the lead sponsor of 465 studies on the registry; 282 are open to participants now.
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Patients diagnosis of "unruptured vertebrobasilar dissecting aneurysm".
Exclusion Criteria:
Patients with unruptured VBDAs did not receive any interventional therapy (including endovascular therapy and microsurgery).
Other: Multi-disciplinary assessment
Patients with unruptured VBDAs receive common stent and coils embolization.
Patients with unruptured VBDAs receive flow diverter treatment.
1. Comprehensive evaluation was performed by multi-disciplinary experts to assess the prognosis of unruptured VBDAs and develop appropriate treatment strategies. 2. Preoperative cranial MRI, CTA, DSA and other imaging tests were used to determine the aneurysm site, morphology, size, presence of compression symptoms, and whether it was accompanied by an intramural hematoma.
Poor prognosis
Defined as an mRS score of 3-6.
Time frame: 6 months, 1 year, 3 years, and 5 years after treatment.
Aneurysm rupture
Severe headache developed after treatment and was confirmed by CT as subarachnoid hemorrhage associated with VBDAs.
Time frame: 6 months, 1 year, 3 years, and 5 years after treatment.
Ischemic stroke
Ischemic stroke refer to in-stent thrombosis, transient ischemic attack, or cerebral infarction associated with the treated vascular area.
Time frame: 6 months, 1 year, 3 years, and 5 years after treatment.
Compression symptom
Compression symptoms refer to cranial neuropathy or brainstem symptoms associated with aneurysm compression.
Time frame: 6 months, 1 year, 3 years, and 5 years after treatment.
VBDA-related death
Patients died during hospitalization or follow-up and were associated with VBDA. The causes of death were categorized as: aneurysm rupture, ischemic stroke, and compression symptoms.
Time frame: 6 months, 1 year, 3 years, and 5 years after treatment.
Improvement of neurological dysfunction
The modified Rankin score was used to evaluate neurological dysfunction: Grade 0, completely asymptomatic; Grade 1, able to complete all daily duties and activities despite symptoms, but without obvious dysfunction; Grade 2, mildly disabled, unable to complete all activities before illness, but does not need help, can take care of themself; Grade 3, moderately disabled, requires some help, but does not need help while walking; Grade 4, severely disabled, unable to walk independently, unable to meet their own needs without help from others; Grade 5, severely disabled, bedridden, incontinence, requiring continuous care And attention; Grade 6, death.
Time frame: 6 months, 1 year, 3 years, and 5 years after treatment.
Rate of complete occlusion of aneurysms
Complete occlusion of the aneurysm was confirmed by DSA, and then the rate of complete occlusion was compared between the groups.
Time frame: 6 months, 1 year, 3 years, and 5 years after treatment.
Aneurysm recanalization
Aneurysm recanalization was confirmed by DSA, and then the rate of aneurysm recanalization was compared between the groups.
Time frame: 6 months, 1 year, 3 years, and 5 years after treatment.
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Beijing Tiantan Hospital