Effect of Surgical Revascularization on Hemorrhagic Moyamoya Disease

NCT03627975 | Unknown

• 1 other identifier: Z171100001017144
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

Moyamoya Disease(MMD), also known as spontaneous basilar artery occlusion, is characterized by the gradual thickening of arterial intima at the distal carotid artery and the proximal portion of anterior/middle cerebral artery, the gradual stenosis or occlusion of arterial lumen, and the compensatory expansion of basilar cerebral perforating arteries. Cerebral infarction and cerebral hemorrhage are common clinical symptoms of MMD with high morbidity of disability. For ischemic moyamoya disease, intracranial/extracranial revascularization is the preferred treatment. However, for patients with hemorrhagic moyamoya disease, there is controversy about whether to have surgical treatment, the timing and the method of surgical treatment, and the effect of surgical treatment to prevent rebleeding due to the lack of large sample, multi-center, prospective randomized studies. At present, the studies on the effect of revascularization and conservative treatment on hemorrhagic moyamoya disease are retrospective case analyses without randomized control. The sample size of these studies are small, and the conclusions obtained are inconsistent. Due to the differences in the epidemiology and episode type of moyamoya disease in different countries, there is no prospective, randomized controlled study of blood type moyamoya disease in China to confirm the efficacy of revascularization and lack of uniform norms and standards.

Conditions

Moyamoya Disease

Keywords

revascularization; hemorrhagic moyamoya disease

Outcome Measures

Primary Outcomes (1)

• Rebleeding

  All enrolled patients were followed up regularly by telephone, outpatient and inpatient visits. The observed end-point events of rebleeding

  Through study completion, an average of 1 year

Secondary Outcomes (3)

• Severe Disability

  Through study completion, an average of 1 year

• Severe Disability or Death

  Through study completion, an average of 1 year

• Vascular Reconstruction due to Progressive Ischemic Stroke or Progressive TIA

  Through study completion, an average of 1 year

Study Arms (3)

Conservative treatment

NO INTERVENTION

Conservative treatment. The conservative treatment of hemorrhagic moyamoya disease mainly includes the control of hypertension, the prevention and treatment of secondary epilepsy, the control of intracranial hypertension(including the application of mannitol and glycerol fructose, etc.), and the corresponding symptomatic and neurotrophic treatment. Non-specific treatment is mainly deal with intracranial hematoma, including intraventricular drainage, intracranial hematoma evacuation, and ventriculoperitoneal shunt.

Indirect vascular reconstruction surgery

EXPERIMENTAL

Indirect vascular reconstruction surgery. In addition to the pharmacotherapy used in conservative treatment, encephalo-duro-arterio-synangiosis(EDAS) is performed. The surgery is performed according to the procedures described by Matsushima.

Procedure: Conservative treatment

direct vascular reconstruction surgery

EXPERIMENTAL

Direct vascular reconstruction surgery. In addition to the pharmacotherapy used in conservative treatment, the superficial temporal artery(STA) and middle cerebral artery(MCA) bypass surgery is performed. The operation is the modified EDAS which basically similar to EDAS, but the surgical incision is as low as possible. And if necessary, the STA may not be preserved. The bone flap should be large enough to select the right recipient blood vessel.

Procedure: Conservative treatment

Interventions

Conservative treatment PROCEDURE

1. The conservative treatment of hemorrhagic moyamoya disease mainly includes the control of hypertension, prevention and treatment of secondary epilepsy, the control of intracranial hypertension, and the corresponding symptomatic and neurotrophic treatment. 2. In addition to the pharmacotherapy used in conservative treatment, encephalo-duro-arterio-synangiosis(EDAS) will be performed according to the procedures described by Matsushima. 3. In addition to the pharmacotherapy used in conservative treatment, the superficial temporal artery(STA) and middle cerebral artery(MCA) by pass surgery is performed. The operation is the modified EDAS which basically similar to EDAS, but the surgical incision is as low as possible. And the STA may not be preserved.

Also known as: indirect revascularization, direct revascularization

Indirect vascular reconstruction surgery; direct vascular reconstruction surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DSA/MRA shows stenosis or occlusion in the distal internal carotid artery or the proximal portion of anterior/middle cerebral artery
• Abnormal vascular network appeared in the brain
• Lesions showed bilateral changes
• Age≥18 years
• With the onset of cerebral hemorrhage
• No cerebral infarction or cerebral hemorrhage occurred within the last month
• At least one month after the acute phase of cerebral hemorrhage or related diseases was treated

You may not qualify if:

• Patients with moyamoya syndrome secondary to systemic diseases such as arteriosclerosis, sickle cell anemia, radiation therapy, etc..
• Patients with severe mental disorders such as psychosis, liver and kidney dysfunction, poor blood pressure or blood glucose control, severe depression and substance abuse, low IQ, and acute phase of severe stroke with definite limb dysfunction should also be excluded.

Sponsors & Collaborators

• Affiliated Hospital to Academy of Military Medical Sciences: lead

Study Sites (1)

The 307th Hospital of Military Chinese People's Liberation Army

Beijing, Beijing Municipality, 100071, China

RECRUITING

MeSH Terms

Conditions

Moyamoya Disease

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Lian Lian, Chief

  The 307th Hospital of Military Chinese People's Liberation Army

  STUDY CHAIR

Central Study Contacts

Lian Duan, Chief

CONTACT

0086-10-66947156; keyan307@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2018
• First Posted: August 14, 2018
• Study Start: October 1, 2017
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2021
• Last Updated: January 31, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)