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Recruiting NCT06541106

Registry of Endovascular Treatment for Vertebrobasilar Dissecting Aneurysms in China

— Observational Dissecting Aneurysm of Cerebral Artery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Multi-disciplinary assessment.
Who it may be relevant to
Registry conditions: Dissecting Aneurysm of Cerebral Artery. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • 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.

Primary outcome measures

  • Poor prognosis [Time frame: 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.]
Secondary outcome measures (6)
  • Ischemic stroke [Time frame: 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.]
  • VBDA-related death [Time frame: 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.]
  • Rate of complete occlusion of aneurysms [Time frame: 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.]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Beijing Tiantan Hospital — Beijing

Publications

  • 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 38578572
  • 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 38212103
  • 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 34935531
  • 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 32745190
  • 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 31838535
  • 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 31601577
  • 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 34891141
  • 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 22550310

Identifiers

NCT: NCT06541106 · VBDAs China

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗