The Adult Hemorrhagic Moyamoya Surgery Study "AHMSS"

Active, not recruiting

Phase 3 Results N/A

Trial Description

The aim of this study is to investigate whether extracranial-intracranial(EC-IC) bypass surgery could prevent rebleeding and improve neurological function in adult moyamoya with hemorrhagic onset.

Detailed Description

About one half of adult moyamoya patients present with hemorrhagic onset.As the bleeding events are potentially fatal, it often lead to particularly poor prognosis.However, the natural history is still poorly understood.Although the rebleeding rate is known to be extremely high,no effective therapeutic method has been established based on a worldwide consensus.
The recently published Japanese Adult Moyamoya(JAM) Trial, which is the first prospective,randomized,controlled trial focused on hemorrhagic moyamoya,showed that direct bypass surgery could reduce the rebleeding rate and improve the prognosis.However,the result was statistically marginal with a small sample size and most importantly,it failed to assess the neurological function.The effect of bypass surgery on functional outcome was uncertain.
Therefore,the AHMSS study in China is designed to compare the efficacy and safety of EC-IC bypass surgery with conservative treatment in adult moyamoya patients with hemorrhagic onset by comprehensive assessment of rebleeding rate, neurological function.

Conditions

Interventions

  • Extracranial-intracranial bypass surgery Procedure
    Other Names: STA-MCA Bypass and EDMS
    Intervention Desc: All participants in this group will undergo combined cerebral revascularization surgery,namely superficial temporal to middle cerebral artery bypass (STA-MCA) and encephalo-duro-myo-synangiosis(EDMS)
    ARM 1: Kind: Experimental
    Label: Surgical intervention
    Description: All participants in this group will be assigned to receive extracranial-intracranial arterial bypass surgery.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary All strokes & death within 30 days post-surgery and ipsilateral recurrent bleeding afterwards within 5 years of randomization No
Secondary All kinds of adverse events related to surgery up to 30 days Yes
Secondary Rebleeding on the contralateral side up to 5 years No
Secondary Transient ischemic attack on the surgically treated side up to 5 years No
Secondary The changes from baseline in modified Rankin Scale (mRS) at 7 days, 30 days, 6 months, 12 months, 24 months, 36 months, 60 months or end of trial No
Secondary The changes from baseline in National Institute of Health Stroke Scale (NIHSS) at 7 days, 30 days, 6 months, 12 months, 24 months, 36 months, 60 months or end of trial No
Secondary The changes from baseline in modified Barthel Index at 7 days, 30 days, 6 months, 12 months, 24 months, 36 months, 60 months or end of trial No

Sponsors