Registry of Endovascular Treatment for Vertebrobasilar Dissecting Aneurysms in China (VBDAs China)

November 22, 2025 updated by: Ming Lv, Beijing Tiantan Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100010
        • Recruiting
        • Beijing Tiantan Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Linggen Dong, MD
        • Principal Investigator:
          • Dachao Wei, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosis of "unruptured vertebrobasilar dissecting aneurysm".

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Conservative management group
Patients with unruptured VBDAs did not receive any interventional therapy (including endovascular therapy and microsurgery).
Other: Multi-disciplinary assessment
  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.
Stent-assisted coiling group
Patients with unruptured VBDAs receive common stent and coils embolization.
Flow diverter group
Patients with unruptured VBDAs receive flow diverter treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Poor prognosis
Time Frame: 6 months, 1 year, 3 years, and 5 years after treatment.
Defined as an mRS score of 3-6.
6 months, 1 year, 3 years, and 5 years after treatment.
Aneurysm rupture
Time Frame: 6 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.
6 months, 1 year, 3 years, and 5 years after treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ischemic stroke
Time Frame: 6 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.
6 months, 1 year, 3 years, and 5 years after treatment.
Compression symptom
Time Frame: 6 months, 1 year, 3 years, and 5 years after treatment.
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
Time Frame: 6 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.
6 months, 1 year, 3 years, and 5 years after treatment.
Improvement of neurological dysfunction
Time Frame: 6 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.
6 months, 1 year, 3 years, and 5 years after treatment.
Rate of complete occlusion of aneurysms
Time Frame: 6 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.
6 months, 1 year, 3 years, and 5 years after treatment.
Aneurysm recanalization
Time Frame: 6 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.
6 months, 1 year, 3 years, and 5 years after treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Estimated)

January 1, 2031

Study Completion (Estimated)

January 1, 2032

Study Registration Dates

First Submitted

August 2, 2024

First Submitted That Met QC Criteria

August 2, 2024

First Posted (Actual)

August 7, 2024

Study Record Updates

Last Update Posted (Actual)

November 28, 2025

Last Update Submitted That Met QC Criteria

November 22, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VBDAs China

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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