Registry of Endovascular Treatment for Vertebrobasilar Dissecting Aneurysms in China
NCT Number: NCT06541106
Acronym: VBDAs China
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Dissecting Aneurysm of Cerebral Artery
Interventions: OTHER: Multi-disciplinary assessment
Sponsor: Beijing Tiantan Hospital
Collaborators: Beijing Chao Yang Hospital|Peking University International Hospital|Capital Medical University|The First People's Hospital of Lianyungang|Chinese PLA General Hospital|Wuhan Union Hospital, China|Yichang Central People's Hospital|Taihe Hospital|Liaocheng People's Hospital|Binzhou People's Hospital|The First Affiliated Hospital of Shanxi Medical University|Beijing Aerospace General Hospital|The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture|The Second Hospital of Hebei Medical University|Dalian Municipal Central Hospital|Shijiazhuang Third Hospital|Affiliated Hospital of Chengde Medical University|Xingtai People's Hospital|Taian City Central Hospital|Wuhan Brain Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2011-01-01
Completion Date: 2032-01-01
Locations: Beijing Tiantan Hospital, Beijing, Beijing, 100010, China

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.

Primary Outcome Measures: Poor prognosis, Defined as an mRS score of 3-6., 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., 6 months, 1 year, 3 years, and 5 years after treatment.
Secondary Outcome Measures: Ischemic stroke, Ischemic stroke refer to in-stent thrombosis, transient ischemic attack, or cerebral infarction associated with the treated vascular area., 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., 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., 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., 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., 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., 6 months, 1 year, 3 years, and 5 years after treatment.