NCT06541106

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
69mo left

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Jan 2011Jan 2032

Study Start

First participant enrolled

January 1, 2011

Completed
13.6 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 7, 2024

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2031

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2032

Last Updated

November 28, 2025

Status Verified

November 1, 2025

Enrollment Period

20 years

First QC Date

August 2, 2024

Last Update Submit

November 22, 2025

Conditions

Keywords

Vertebrobasilar dissecting aneurysmsEndovascular treatmentPrognosisHemorrhagic stroke

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Ischemic stroke

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

  • Compression symptom

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

  • VBDA-related death

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

  • Improvement of neurological dysfunction

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

  • Rate of complete occlusion of aneurysms

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

  • +1 more secondary outcomes

Study Arms (3)

Conservative management group

Patients with unruptured VBDAs did not receive any interventional therapy (including endovascular therapy and microsurgery).

Other: Multi-disciplinary assessment

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.

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.

Conservative management group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosis of "unruptured vertebrobasilar dissecting aneurysm".

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100010, China

RECRUITING

Related Publications (10)

  • Huang LT, Zhang M, Tong X. Cerebral revascularization for complex vertebrobasilar artery dissecting aneurysms. Neurosurg Rev. 2024 Apr 5;47(1):138. doi: 10.1007/s10143-024-02365-5.

    PMID: 38578572BACKGROUND
  • Amoukhteh M, Hassankhani A, Valizadeh P, Jannatdoust P, Ghozy S, Kobeissi H, Kallmes DF. Flow diverters in the treatment of intracranial dissecting aneurysms: a systematic review and meta-analysis of safety and efficacy. J Neurointerv Surg. 2024 Sep 17;16(10):1005-1012. doi: 10.1136/jnis-2023-021117.

    PMID: 38212103BACKGROUND
  • Dmytriw AA, Alrashed A, Enriquez-Marulanda A, Medhi G, Mendes Pereira V. Unruptured Intradural Posterior Circulation Dissecting/Fusiform Aneurysms Natural History and Treatment Outcome. Interv Neuroradiol. 2023 Feb;29(1):56-62. doi: 10.1177/15910199211068673. Epub 2021 Dec 22.

    PMID: 34935531BACKGROUND
  • Nakatomi H, Kiyofuji S, Ono H, Tanaka M, Kamiyama H, Takizawa K, Imai H, Saito N, Shiokawa Y, Morita A, Flemming KD, Link MJ. Giant Fusiform and Dolichoectatic Aneurysms of the Basilar Trunk and Vertebrobasilar Junction-Clinicopathological and Surgical Outcome. Neurosurgery. 2020 Dec 15;88(1):82-95. doi: 10.1093/neuros/nyaa317.

    PMID: 32745190BACKGROUND
  • Adeeb N, Ogilvy CS, Griessenauer CJ, Thomas AJ. Expanding the Indications for Flow Diversion: Treatment of Posterior Circulation Aneurysms. Neurosurgery. 2020 Jan 1;86(Suppl 1):S76-S84. doi: 10.1093/neuros/nyz344.

    PMID: 31838535BACKGROUND
  • Cho DY, Kim BS, Choi JH, Park YK, Shin YS. The Fate of Unruptured Intracranial Vertebrobasilar Dissecting Aneurysm with Brain Stem Compression According to Different Treatment Modalities. AJNR Am J Neuroradiol. 2019 Nov;40(11):1924-1931. doi: 10.3174/ajnr.A6252. Epub 2019 Oct 10.

    PMID: 31601577BACKGROUND
  • Frisoli FA, Srinivasan VM, Catapano JS, Rudy RF, Nguyen CL, Jonzzon S, Korson C, Karahalios K, Lawton MT. Vertebrobasilar dissecting aneurysms: microsurgical management in 42 patients. J Neurosurg. 2021 Dec 10;137(2):393-401. doi: 10.3171/2021.9.JNS21397. Print 2022 Aug 1.

    PMID: 34891141BACKGROUND
  • Ahn SS, Kim BM, Suh SH, Kim DJ, Kim DI, Shin YS, Ha SY, Kwon YS. Spontaneous symptomatic intracranial vertebrobasilar dissection: initial and follow-up imaging findings. Radiology. 2012 Jul;264(1):196-202. doi: 10.1148/radiol.12112331. Epub 2012 May 1.

    PMID: 22550310BACKGROUND
  • Zhang Y, Tian Z, Sui B, Wang Y, Liu J, Li M, Li Y, Jiang C, Yang X. Endovascular Treatment of Spontaneous Intracranial Fusiform and Dissecting Aneurysms: Outcomes Related to Imaging Classification of 309 Cases. World Neurosurg. 2017 Feb;98:444-455. doi: 10.1016/j.wneu.2016.11.074. Epub 2016 Nov 24.

    PMID: 27890754BACKGROUND
  • Sonmez O, Brinjikji W, Murad MH, Lanzino G. Deconstructive and Reconstructive Techniques in Treatment of Vertebrobasilar Dissecting Aneurysms: A Systematic Review and Meta-Analysis. AJNR Am J Neuroradiol. 2015 Jul;36(7):1293-8. doi: 10.3174/ajnr.A4360. Epub 2015 May 7.

    PMID: 25953763BACKGROUND

MeSH Terms

Conditions

Hemorrhagic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Linggen Dong, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 2, 2024

First Posted

August 7, 2024

Study Start

January 1, 2011

Primary Completion (Estimated)

January 1, 2031

Study Completion (Estimated)

January 1, 2032

Last Updated

November 28, 2025

Record last verified: 2025-11

Locations