Multiple Burrhole Therapy With Erythropoietin for Unstable Moyamoya

Phase 1

Completed

• Conditions: Moyamoya Disease; Ischemic Attack; Ischemic Stroke; Burr Hole; Angiogenesis
• Interventions: Drug: erythropoietin

• Registration Number: NCT03162588
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2010-05-01
• Primary Completion: 2016-09-30
• Study Completion: 2016-09-30
• Study First Submitted: 2017-05-18
• Study First Submitted QC: 2017-05-19
• Study First Posted: 2017-05-22
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-19
• Last Update Posted: 2017-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
multiple burrhole therapy and erythropoietin	erythropoietin	pretreatment with IV erythropoietin for 3 days, 120000IU#3 then multiple burrhole procedure on the hemisphere effected is performed

Primary Outcome Measures

Name	Time	Method
Functional status of the participants after 6 months of procedure assessed by modified Rankin Scale.	6 month post-procedure	The functional status of participants will be assessed based on modified Rankin Scale for evaluation of feasibility of procedure.
transdural arteriogenesis	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

Name	Time	Method
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.	periprocedural and post-procedural complications

Trial Locations

Locations (1)

Ajou University Medical Center; 🇰🇷 Suwon, Gyunggido, Korea, Republic of