Precision Bypass in Patients With Moyamoya Disease (PBM)
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|ClinicalTrials.gov Identifier: NCT03516851|
Recruitment Status : Recruiting
First Posted : May 4, 2018
Last Update Posted : August 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Moyamoya Disease||Procedure: Precision bypass group||Not Applicable|
There are no effective medical therapies for moyamoya disease. Through the provision of collateral pathways, surgical revascularisation is the most successful therapy to improve cerebral haemodynamics, and to reduce the risk of subsequent stroke. Surgical procedures for moyamoya disease can be classified into three categories: direct bypass, indirect bypass, and combined bypass. Although surgeons have their own experience choosing the recipient vessels,no standard has been established based on a worldwide consensus.
Intraoperative ICG angiography using Flow800 software and multimodal neuronavigation (structure combined with perfusion MRI sequence) can be used to assess the real-time cerebral blood flow velocity and perfusion of local brain tissue, which is contribute to choose a recipient vessels with relative low cerebral blood flow velocity and perfusion.
Therefore,the PBM study in our institution is designed to compare the direct bypass surgery with multimodal neuronavigation with traditional direct bypass procedure alone in preventing any ischemic event afterwards after cerebral revascularization surgery in adult ischemic MMD patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multimodal Neuronavigation Guiding Precision Bypass in Adult Ischemic Patients With Moyamoya Disease|
|Actual Study Start Date :||August 1, 2018|
|Estimated Primary Completion Date :||August 1, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Active Comparator: Precision bypass group
Using ICG with Flow800 software and multimodal neuronavigation to choose the recipient vessel
Procedure: Precision bypass group
With the brain cortex exposed after craniotomy, an initial ICG fluorescence angiography will be performed. ICG fluorescence angiography using Flow800 software to determine blood flow velocity and cortical perfusion in different candidate receptors. And electromagnetic neuronavigation system is used to evaluate the cerebral flow under different candidate recipient vessels. The treatment planning station will be situated based on the multimodal neuronavigation data. The vessel was chose as the receptor with lower flow velocity and lower cerebral perfusion area to perform anastomosis. Then a direct bypass surgery will be performed just like in the empirical direct bypass surgery group.
No Intervention: Empirical group
choosing the recipient vessel by the surgeon's own experience
- ischemic events [ Time Frame: 30 days ]All strokes & death within 30 days post-surgery and ipsilateral infarctions afterwards
- postoperative complications [ Time Frame: 30 days ]All kinds of adverse events related to surgery within 30 days
- Infarctions [ Time Frame: 1 years ]Infarctions on the contralateral side within 1 year of randomization
- Transient ischemic attack (TIA) [ Time Frame: 1 years ]Transient ischemic attack on the surgically treated side within 1 year of randomization
- Cerebral Blood Flow (CBF) [ Time Frame: at 7days, 3 months, 6 months, 12 months or end of trial ]The changes from baseline in CBF measured by arterial spin labeling (ASL) at 7days, 3 months, 6 months, 12 months or end of trial
- modified Rankin Scale (mRS) [ Time Frame: at 7 days, 3 months, 6 months, 12 months or end of trial ]The changes from baseline in modified Rankin Scale (mRS) at 7 days, 3 months, 6 months, 12 months or end of trial. The mRS ranges from 0-6. A mRS of 0-2 is identified as a favourable outcome, and a score of 3-6 as an unfavourable outcome.
- National Institute of Health Stroke Scale (NIHSS) [ Time Frame: at 7 days, 3 months, 6 months, 12 months or end of trial ]The changes from baseline in National Institute of Health Stroke Scale (NIHSS) at 7 days, 3 months, 6 months, 12 months or end of trial. A total score will be calculated and ranges from 0-42. A NIHSS of 0-14 is identified as a favourable outcome, and a score of 15-42 as an unfavourable outcome.
- modified Barthel Index [ Time Frame: at 7 days, 3 months, 6 months, 12 months or end of trial ]The changes from baseline in modified Barthel Index at 7 days, 3 months, 6 months, 12 months or end of trial
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 ClinicalTrials.gov identifier (NCT number): NCT03516851
|Contact: Yuanli Zhao, MDemail@example.com|
|Contact: Rong Wang, PhDfirstname.lastname@example.org|
|Beijing Tiantan Hospital, Capital Medical University||Not yet recruiting|
|Beijing, Beijing, China, 10050|
|Contact: Yuanli Zhao, MD +8613801121203 email@example.com|
|Contact: Rong Wang, PhD 13001190333 firstname.lastname@example.org|
|Principal Investigator: Yuanli Zhao, MD|
|Sub-Investigator: Rong Wang, PhD|
|Sub-Investigator: Xiaolin Chen, PhD|
|Peking University International Hospital||Recruiting|
|Beijing, Beijing, China, 102200|
|Contact: Xiaolin Chen, PhD +8613810624845 email@example.com|
|Contact: Junlin Lu, MD +8618583638728 firstname.lastname@example.org|
|Principal Investigator: Yuanli Zhao, MD|
|Sub-Investigator: Rong Wang, MD|
|Sub-Investigator: Xiaolin Chen, MD|
|Study Director:||Xiaolin Chen, PhD||Beijing Tiantan Hospital|
|Study Chair:||Junlin Lu, MD||Beijing Tiantan Hospital|