Multiple Burrhole Therapy With Erythropoietin for Unstable Moyamoya

Completed

Phase 1/2 Results N/A

Trial Description

In this study, the investigators aim to evaluate the indirect revascularization outcomes of a new combination therapy of multiple burrhole procedure with promotion of arteriogenesis by intravenous (IV) erythropoietin (EPO) pretreatment on Moyamoya patients with acute neurological presentation, and outline the clinical and vascular factors associated with revascularization through the burrholes.

Detailed Description

This is a investigator led, single-center, single arm, interventional trial in prospective Moyamoya disease (MMD) and Moyamoya syndrome (MMS) registry. MMD or MMS patients with acute neurological presentation such as ischemic stroke or transient ischemic attack are eligible.
After inclusion, initial evaluation including transfemoral angiography is performed. A 3 day pre-procedure IV erythropoietin (120000 international units[IU] #3) is given for promotion of arteriogenesis, than multiple burrhole procedure is performed. Arteriogenesis is evaluated by 6 month transfemoral angiography.

Conditions

Interventions

  • Erythropoietin Drug
    Other Names: multiple burrhole procedure
    Intervention Desc: EpokineĀ®, CJ healthcare, South Korea is used preprocedurally to promote revascularization. Total 120,000 units of EPO is injected for three consecutive days, 40,000 units mixed in IV saline 100 ml over 1 hour. The multiple burrhole procedure is performed in area of hemodynamic insufficiency by D-SPECT. It is performed under local anesthesia.
    ARM 1: Kind: Experimental
    Label: multiple burrhole therapy and erythropoietin
    Description: pretreatment with IV erythropoietin for 3 days, 120000IU#3 then multiple burrhole procedure on the hemisphere effected is performed

Outcomes

Type Measure Time Frame Safety Issue
Primary Functional status of the participants after 6 months of procedure assessed by modified Rankin Scale. 6 month post-procedure
Secondary transdural arteriogenesis 6 month post-procedural cerebral angiography
Secondary Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 Any complications occuring within <14 days of burrhole procedure + erythropoietin is classified as periprocedural complications. Any complications occuring or detected after 14 days of procedure up to 6 months will be classified as post-procedural.

Sponsors