Registry of Endovascular Treatment for Vertebrobasilar Dissecting Aneurysms in China

NCT ID: NCT06541106

Last Updated: 2025-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-01

Study Completion Date

2032-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Dissecting Aneurysm of Cerebral Artery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Conservative management group

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

Multi-disciplinary assessment

Intervention Type OTHER

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.

No interventions assigned to this group

Flow diverter group

Patients with unruptured VBDAs receive flow diverter treatment.

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Chao Yang Hospital

OTHER

Sponsor Role collaborator

Peking University International Hospital

OTHER

Sponsor Role collaborator

The First People's Hospital of Lianyungang

OTHER

Sponsor Role collaborator

Chinese PLA General Hospital

OTHER

Sponsor Role collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role collaborator

Yichang Central People's Hospital

OTHER

Sponsor Role collaborator

Taihe Hospital

OTHER

Sponsor Role collaborator

Liaocheng People's Hospital

OTHER

Sponsor Role collaborator

Binzhou People's Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Shanxi Medical University

OTHER

Sponsor Role collaborator

Beijing Aerospace General Hospital

OTHER

Sponsor Role collaborator

The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture

OTHER

Sponsor Role collaborator

The Second Hospital of Hebei Medical University

OTHER

Sponsor Role collaborator

Dalian Municipal Central Hospital

OTHER

Sponsor Role collaborator

Shijiazhuang Third Hospital

UNKNOWN

Sponsor Role collaborator

Affiliated Hospital of Chengde Medical University

OTHER

Sponsor Role collaborator

Xingtai People's Hospital

OTHER

Sponsor Role collaborator

Taian City Central Hospital

OTHER

Sponsor Role collaborator

Wuhan Brain Hospital

UNKNOWN

Sponsor Role collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ming Lv

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Linggen Dong, MD

Role: CONTACT

+8613701376177

Ming Lv, Ph D.

Role: CONTACT

+8618844738529

Facility Contacts

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Ming Lv, MD,PhD

Role: primary

+8613701376177

Linggen Dong, MD

Role: backup

+8618844738529

References

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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.

Reference Type BACKGROUND
PMID: 38578572 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38212103 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34935531 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32745190 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31838535 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31601577 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34891141 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22550310 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27890754 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25953763 (View on PubMed)

Other Identifiers

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VBDAs China

Identifier Type: -

Identifier Source: org_study_id

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