Clinical Trial: Multiple Burrhole Therapy With Erythropoietin for Unstable Moyamoya

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Feasibility Study of Multiple Burrhole Therapy Combined With Intravenous Erythropoietin Pretreatment for Unstable Moyamoya

Brief Summary: 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 Summary:

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.


Sponsor: Ajou University School of Medicine

Current Primary Outcome: Functional status of the participants after 6 months of procedure assessed by modified Rankin Scale. [ Time Frame: 6 month post-procedure ]

The functional status of participants will be assessed based on modified Rankin Scale for evaluation of feasibility of procedure.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • transdural arteriogenesis [ Time Frame: 6 month post-procedural cerebral angiography ]
    the extent of collateral flow that has developed from external carotid artery to internal carotid artery through the burrholes
  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 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. ]
    periprocedural and post-procedural complications


Original Secondary Outcome: Same as current

Information By: Ajou University School of Medicine

Dates:
Date Received: May 18, 2017
Date Started: May 1, 2010
Date Completion:
Last Updated: May 19, 2017
Last Verified: May 2017