Registry of Endovascular Treatment for Vertebrobasilar Dissecting Aneurysms in China

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorBeijing Tiantan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-80 years old;

Patients diagnosis of "unruptured vertebrobasilar dissecting aneurysm".

Disqualifiers

Patients did not undergo a cranial MRI;

Missing critical clinical baseline;

Missing pre-treatment imaging;

Receiving microsurgery;

Trial population

Patients diagnosis of "unruptured vertebrobasilar dissecting aneurysm".

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Multi-disciplinary assessment

    Other intervention

    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.

Treatment groups

2,000 Participants
are divided into 3 treatment groups
Group A: Conservative management group1 intervention
Group B: Stent-assisted coiling group0 interventions
Group C: Flow diverter group0 interventions

Trial outcomes

Primary outcomes

1

Poor prognosis

Defined as an mRS score of 3-6.

Time frame
6 months, 1 year, 3 years, and 5 years after treatment.
2

Aneurysm rupture

Severe headache developed after treatment and was confirmed by CT as subarachnoid hemorrhage associated with VBDAs.

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

Secondary outcomes

1

Ischemic stroke

Ischemic stroke refer to in-stent thrombosis, transient ischemic attack, or cerebral infarction associated with the treated vascular area.

Time frame
6 months, 1 year, 3 years, and 5 years after treatment.
2

Compression symptom

Compression symptoms refer to cranial neuropathy or brainstem symptoms associated with aneurysm compression.

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

VBDA-related death

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.

Time frame
6 months, 1 year, 3 years, and 5 years after treatment.
4

Improvement of neurological dysfunction

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Tiantan Hospital

Lead sponsor

Beijing Chao Yang Hospital

Collaborator

Peking University International Hospital

Collaborator

The First People's Hospital of Lianyungang

Collaborator

Chinese PLA General Hospital

Collaborator

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

Collaborator

Yichang Central People's Hospital

Collaborator

Taihe Hospital

Collaborator

Liaocheng People's Hospital

Collaborator

Binzhou People's Hospital

Collaborator

The First Affiliated Hospital of Shanxi Medical University

Collaborator

Beijing Aerospace General Hospital

Collaborator

The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture

Collaborator

The Second Hospital of Hebei Medical University

Collaborator

Dalian Municipal Central Hospital

Collaborator

Shijiazhuang Third Hospital

Collaborator

Affiliated Hospital of Chengde Medical University

Collaborator

Xingtai People's Hospital

Collaborator

Taian City Central Hospital

Collaborator

Wuhan Brain Hospital

Collaborator