Multiple Burrhole Therapy With Erythropoietin for Unstable Moyamoya

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03162588
• Other study ID #: AJIRB-MED-T12-11-065
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 18, 2017
• Last updated: June 19, 2017
• Start date: May 1, 2010
• Est. completion date: September 30, 2016

Study information

• Verified date: June 2017
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: September 30, 2016
• Est. primary completion date: September 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angiogenesis
• Burr Hole
• Ischemia
• Ischemic Attack
• Ischemic Stroke
• Moyamoya Disease

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Ajou University Medical Center	Suwon	Gyunggido

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional status of the participants after 6 months of procedure assessed by modified Rankin Scale.	The functional status of participants will be assessed based on modified Rankin Scale for evaluation of feasibility of procedure.	6 month post-procedure
Primary	transdural arteriogenesis	the extent of collateral flow that has developed from external carotid artery to internal carotid artery through the burrholes	6 month post-procedural cerebral angiography
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	periprocedural and post-procedural complications	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.