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Registry of Endovascular Treatment for Vertebrobasilar Dissecting Aneurysms in China

Registry of Endovascular Treatment for Vertebrobasilar Dissecting Aneurysms in China

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06541106
Acronym
VBDAs China
Enrollment
2000
Registered
2024-08-07
Start date
2011-01-01
Completion date
2032-01-01
Last updated
2025-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dissecting Aneurysm of Cerebral Artery

Keywords

Vertebrobasilar dissecting aneurysms, Endovascular treatment, Prognosis, Hemorrhagic stroke

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.

Interventions

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.

Sponsors

Beijing Chao Yang Hospital
CollaboratorOTHER
Peking University International Hospital
CollaboratorOTHER
The First People's Hospital of Lianyungang
CollaboratorOTHER
Chinese PLA General Hospital
CollaboratorOTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
CollaboratorOTHER
Yichang Central People's Hospital
CollaboratorOTHER
Taihe Hospital
CollaboratorOTHER
Liaocheng People's Hospital
CollaboratorOTHER
Binzhou People's Hospital
CollaboratorOTHER
The First Affiliated Hospital of Shanxi Medical University
CollaboratorOTHER
Beijing Aerospace General Hospital
CollaboratorOTHER
The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture
CollaboratorOTHER
The Second Hospital of Hebei Medical University
CollaboratorOTHER
Dalian Municipal Central Hospital
CollaboratorOTHER
Shijiazhuang Third Hospital
CollaboratorUNKNOWN
Affiliated Hospital of Chengde Medical University
CollaboratorOTHER
Xingtai People's Hospital
CollaboratorOTHER
Taian City Central Hospital
CollaboratorOTHER
Wuhan Brain Hospital
CollaboratorUNKNOWN
Beijing Tiantan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Poor prognosis6 months, 1 year, 3 years, and 5 years after treatment.Defined as an mRS score of 3-6.
Aneurysm rupture6 months, 1 year, 3 years, and 5 years after treatment.Severe headache developed after treatment and was confirmed by CT as subarachnoid hemorrhage associated with VBDAs.

Secondary

MeasureTime frameDescription
VBDA-related death6 months, 1 year, 3 years, and 5 years after treatment.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 dysfunction6 months, 1 year, 3 years, and 5 years after treatment.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.
Ischemic stroke6 months, 1 year, 3 years, and 5 years after treatment.Ischemic stroke refer to in-stent thrombosis, transient ischemic attack, or cerebral infarction associated with the treated vascular area.
Aneurysm recanalization6 months, 1 year, 3 years, and 5 years after treatment.Aneurysm recanalization was confirmed by DSA, and then the rate of aneurysm recanalization was compared between the groups.
Rate of complete occlusion of aneurysms6 months, 1 year, 3 years, and 5 years after treatment.Complete occlusion of the aneurysm was confirmed by DSA, and then the rate of complete occlusion was compared between the groups.
Compression symptom6 months, 1 year, 3 years, and 5 years after treatment.Compression symptoms refer to cranial neuropathy or brainstem symptoms associated with aneurysm compression.

Countries

China

Contacts

Primary ContactLinggen Dong, MD
donglinggen@163.com+8613701376177
Backup ContactMing Lv, Ph D.
dragontiger@163.com+8618844738529

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026