Effect of Surgical Revascularization on Hemorrhagic Moyamoya Disease (ESRHMMD)
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|ClinicalTrials.gov Identifier: NCT03627975|
Recruitment Status : Recruiting
First Posted : August 14, 2018
Last Update Posted : January 31, 2019
|Condition or disease||Intervention/treatment||Phase|
|Moyamoya Disease||Procedure: Conservative treatment||Not Applicable|
Objective: The aim of this study is to perform a prospective, randomized study on hemorrhagic moyamoya disease to confirm the effect of revascularization in China, and to establish specifications and standards to guide the treatment options for hemorrhagic moyamoya disease as well.
Design: This study is a single-center study and plan to include 108 patients. According to a random number table, hemorrhagic moyamoya patients will be assigned to three groups: conservative treatment group, direct revascularization group and indirect revascularization group. A prospective, randomized study will be carried out to evaluate the effect of revascularization and conservative treatment on the reduction of rebleeding risk and improvement of ischemia in adult patients with hemorrhagic moyamoya disease.
Observation Measures: 1.Rebleeding; 2.Cerebral infarction resulting in severe disability (mRS score≥3); 3.Severe disability or death caused by other reasons; 4. Patients in conservative treatment group need revascularization due to progressive ischemic stroke or progressive Transient ischemic attack(TIA).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Surgical Revascularization and Conservative Treatment on Hemorrhagic Moyamoya Disease|
|Actual Study Start Date :||October 1, 2017|
|Estimated Primary Completion Date :||October 1, 2020|
|Estimated Study Completion Date :||October 1, 2021|
No Intervention: Conservative treatment
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.
Experimental: Indirect vascular reconstruction surgery
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
Experimental: direct vascular reconstruction surgery
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
- Rebleeding [ Time Frame: Through study completion, an average of 1 year ]All enrolled patients were followed up regularly by telephone, outpatient and inpatient visits. The observed end-point events of rebleeding
- Severe Disability [ Time Frame: Through study completion, an average of 1 year ]Cerebral infarction resulting in severe disability (mRS score≥3)
- Severe Disability or Death [ Time Frame: Through study completion, an average of 1 year ]Severe disability or death caused by other reasons
- Vascular Reconstruction due to Progressive Ischemic Stroke or Progressive TIA [ Time Frame: Through study completion, an average of 1 year ]Patients in conservative treatment group needs vascular reconstruction due to progressive ischemic stroke or progressive TIA.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03627975
|Contact: Lian Duan, Chiefemail@example.com|
|The 307th Hospital of Military Chinese People's Liberation Army||Recruiting|
|Beijing, Beijing, China, 100071|
|Contact: Lian Duan, Chief|
|Study Chair:||Lian Lian, Chief||The 307th Hospital of Military Chinese People's Liberation Army|