Multiple Burrhole Therapy With Erythropoietin for Unstable Moyamoya
|ClinicalTrials.gov Identifier: NCT03162588|
Recruitment Status : Completed
First Posted : May 22, 2017
Last Update Posted : June 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Attack Ischemic Stroke Moyamoya Disease Burr Hole Angiogenesis||Drug: erythropoietin||Phase 1 Phase 2|
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)|
|Official Title:||Feasibility Study of Multiple Burrhole Therapy Combined With Intravenous Erythropoietin Pretreatment for Unstable Moyamoya|
|Actual Study Start Date :||May 1, 2010|
|Actual Primary Completion Date :||September 30, 2016|
|Actual Study Completion Date :||September 30, 2016|
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
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
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03162588
|Korea, Republic of|
|Ajou University Medical Center|
|Suwon, Gyunggido, Korea, Republic of|
|Principal Investigator:||Ji Man Hong||assistant professor of neurology|