Registry of Endovascular Treatment for Vertebrobasilar Dissecting Aneurysms in China

Recruiting

• Conditions: Dissecting Aneurysm of Cerebral Artery
• Interventions: Other: Multi-disciplinary assessment

• Registration Number: NCT06541106
• Lead Sponsor: Beijing Tiantan Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-02
• Study First Submitted QC: 2024-08-02
• Last Update Submitted: 2024-08-02
• Study First Posted: 2024-08-07
• Last Update Posted: 2024-08-07
• Primary Completion: 2031-01-01
• Study Completion: 2032-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Conservative management group	Multi-disciplinary assessment	Patients with unruptured VBDAs did not receive any interventional therapy (including endovascular therapy and microsurgery).

Primary Outcome Measures

Name	Time	Method
Poor prognosis	6 months, 1 year, 3 years, and 5 years after treatment.	Defined as an mRS score of 3-6.
Aneurysm rupture	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 Outcome Measures

Name	Time	Method
VBDA-related death	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.
Ischemic stroke	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.
Compression symptom	6 months, 1 year, 3 years, and 5 years after treatment.	Compression symptoms refer to cranial neuropathy or brainstem symptoms associated with aneurysm compression.
Rate of complete occlusion of aneurysms	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.
Aneurysm recanalization	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.
Improvement of neurological dysfunction	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.

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China