Multiple Burrhole Therapy With Erythropoietin for Unstable Moyamoya

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03162588
Recruitment Status : Completed
First Posted : May 22, 2017
Last Update Posted : June 20, 2017
Information provided by (Responsible Party):
Ji Man Hong, Ajou University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Ischemic Attack Ischemic Stroke Moyamoya Disease Burr Hole Angiogenesis Drug: erythropoietin Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study of Multiple Burrhole Therapy Combined With Intravenous Erythropoietin Pretreatment for Unstable Moyamoya
Actual Study Start Date : May 1, 2010
Primary Completion Date : September 30, 2016
Study Completion Date : September 30, 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: multiple burrhole therapy and erythropoietin
pretreatment with IV erythropoietin for 3 days, 120000IU#3 then multiple burrhole procedure on the hemisphere effected is performed
Drug: erythropoietin
Epokine®, 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.
Other Name: multiple burrhole procedure

Primary Outcome Measures :
  1. 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.

  2. 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

Secondary Outcome Measures :
  1. 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

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age ≥16 years
  • Acute neurological presentation with recurrent transient ischemic attacks (TIA) or cerebral infarction within 30 days of symptom onset
  • Angiographic findings compatible with the diagnostic criteria for MMD or MMS (unilateral findings, bilateral distal internal carotid artery involvement without Moyamoya vessels, or presence of other causative factors)
  • Significant decrease in basal perfusion and reservoir capacity on brain perfusion CT or Brain single photon emission computed tomography with acetazolamide (Diamox®) challenge (D-SPECT)

Exclusion Criteria:

  • Definite presence of transdural collateral flow on cerebral angiography.
  • Sufficient perfusion status via Willisian, leptomeningeal, or other collateral systems, as evaluated by multimodal imaging methods.
  • > 30 days after symptom onset

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03162588

Korea, Republic of
Ajou University Medical Center
Suwon, Gyunggido, Korea, Republic of
Sponsors and Collaborators
Ajou University School of Medicine
Principal Investigator: Ji Man Hong assistant professor of neurology

Responsible Party: Ji Man Hong, Associate Proffessor of Neurology, Ajou University School of Medicine Identifier: NCT03162588     History of Changes
Other Study ID Numbers: AJIRB-MED-T12-11-065
First Posted: May 22, 2017    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Cerebral Arterial Diseases
Moyamoya Disease
Pathologic Processes
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Intracranial Arterial Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Epoetin Alfa