Clinical trial NCT06541106: Registry of Endovascular Treatment for Vertebrobasilar Dissecting Aneurysms in China
Official title: Registry of Endovascular Treatment for Vertebrobasilar Dissecting Aneurysms in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dissecting Aneurysm of Cerebral Artery
Keywords: Vertebrobasilar dissecting aneurysms
Endovascular treatment
Prognosis
Hemorrhagic stroke
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Chao Yang Hospital
name: Peking University International Hospital
name: Capital Medical University
name: The First People's Hospital of Lianyungang
name: Chinese PLA General Hospital
name: Wuhan Union Hospital, China
name: Yichang Central People's Hospital
name: Taihe Hospital
name: Liaocheng People's Hospital
name: Binzhou People's Hospital
name: The First Affiliated Hospital of Shanxi Medical University
name: Beijing Aerospace General Hospital
name: The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture
name: The Second Hospital of Hebei Medical University
name: Dalian Municipal Central Hospital
name: Shijiazhuang Third Hospital
name: Affiliated Hospital of Chengde Medical University
name: Xingtai People's Hospital
name: Taian City Central Hospital
name: Wuhan Brain Hospital
First posted: 2024-08-07
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosis of "unruptured vertebrobasilar dissecting aneurysm".

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).

Primary outcomes:
measure: Poor prognosis
timeFrame: 6 months, 1 year, 3 years, and 5 years after treatment.
measure: Aneurysm rupture
timeFrame: 6 months, 1 year, 3 years, and 5 years after treatment.
Secondary outcomes:
measure: Ischemic stroke
timeFrame: 6 months, 1 year, 3 years, and 5 years after treatment.
measure: Compression symptom
timeFrame: 6 months, 1 year, 3 years, and 5 years after treatment.
measure: VBDA-related death
timeFrame: 6 months, 1 year, 3 years, and 5 years after treatment.
measure: Improvement of neurological dysfunction
timeFrame: 6 months, 1 year, 3 years, and 5 years after treatment.
measure: Rate of complete occlusion of aneurysms
timeFrame: 6 months, 1 year, 3 years, and 5 years after treatment.
measure: Aneurysm recanalization
timeFrame: 6 months, 1 year, 3 years, and 5 years after treatment.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
References:
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