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NCT Number: NCT06541106

Registry of Endovascular Treatment for Vertebrobasilar Dissecting Aneurysms in China

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-80 years old;
  • Patients diagnosis of "unruptured vertebrobasilar dissecting aneurysm".

Exclusion criteria

  • Patients did not undergo a cranial MRI;
  • Missing critical clinical baseline;
  • Missing pre-treatment imaging;
  • Receiving microsurgery;
  • The combination of other serious diseases during diagnosis will significantly affect the follow-up of patients;
  • CT/MRI shows intracranial hemorrhage or subarachnoid hemorrhage (SWI microbleeds are ignored).

Treatment and study plan

Multi-disciplinary assessment

Other
  • Comprehensive evaluation was performed by multi-disciplinary experts to assess the prognosis of unruptured VBDAs and develop appropriate treatment strategies.
  • 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.

Primary outcomes

  1. Poor prognosis

    Time frame: 6 months, 1 year, 3 years, and 5 years after treatment.

    Defined as an mRS score of 3-6.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Linggen Dong, MD

CONTACT

[email protected]

+8613701376177

Ming Lv, Ph D.

CONTACT

[email protected]

+8618844738529

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

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

Registry information

Acronym: VBDAs China

Important dates

Study start
2011
Primary completion
2031
Study completion
2032
First posted
Aug 7, 2024
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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