About this trial
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
This trial does not accept healthy volunteersQualifiers
Age 18-80 years old;
Patients diagnosis of "unruptured vertebrobasilar dissecting aneurysm".
Disqualifiers
Patients did not undergo a cranial MRI;
Missing critical clinical baseline;
Missing pre-treatment imaging;
Receiving microsurgery;
Trial population
Patients diagnosis of "unruptured vertebrobasilar dissecting aneurysm".
Trial design
Cohort
Prospective
Treatments tested in this trial
Multi-disciplinary assessment
Other intervention1. 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.
Treatment groups
Trial outcomes
Primary outcomes
Poor prognosis
Defined as an mRS score of 3-6.
Aneurysm rupture
Severe headache developed after treatment and was confirmed by CT as subarachnoid hemorrhage associated with VBDAs.
Secondary outcomes
Ischemic stroke
Ischemic stroke refer to in-stent thrombosis, transient ischemic attack, or cerebral infarction associated with the treated vascular area.
Compression symptom
Compression symptoms refer to cranial neuropathy or brainstem symptoms associated with aneurysm compression.
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.
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.
Sponsors and contacts
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Beijing Tiantan Hospital
Lead sponsor
Beijing Chao Yang Hospital
Collaborator
Peking University International Hospital
Collaborator
The First People's Hospital of Lianyungang
Collaborator
Chinese PLA General Hospital
Collaborator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
Yichang Central People's Hospital
Collaborator
Taihe Hospital
Collaborator
Liaocheng People's Hospital
Collaborator
Binzhou People's Hospital
Collaborator
The First Affiliated Hospital of Shanxi Medical University
Collaborator
Beijing Aerospace General Hospital
Collaborator
The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture
Collaborator
The Second Hospital of Hebei Medical University
Collaborator
Dalian Municipal Central Hospital
Collaborator
Shijiazhuang Third Hospital
Collaborator
Affiliated Hospital of Chengde Medical University
Collaborator
Xingtai People's Hospital
Collaborator
Taian City Central Hospital
Collaborator
Wuhan Brain Hospital
Collaborator