Precision Bypass in Patients With Moyamoya Disease

Status Withdrawn

Clinical Trial Summary

Extracranial-intracranial arterial bypass, including anastomosis of the superficial temporal artery to the middle cerebral artery and indirect bypass, can help prevent further ischaemic attacks in patients with Moyamoya disease (MMD). However, there is no established standard for the selection of the recipient vessels. In most situations, surgeons choose the recipient vessels with their own experiences. Intraoperative Indocyanine green (ICG) angiography using Flow800 software and multimodal neuronavigation can be used to assess the real-time cerebral blood flow velocity and perfusion of local brain tissue for better selection of the recipient vessels. Thus the aim of this study is to to determine whether direct bypass surgery combined with multimodal neuronavigation is superior to traditional direct bypass procedure alone in adult ischemic MMD patients.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Moyamoya Disease

Clinical Trial Details

NCT number	NCT03516851
Study type	Interventional
Source	Peking University International Hospital
Contact
Status	Withdrawn
Phase	N/A
Start date	August 1, 2018
Completion date	December 31, 2020

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Precision Bypass in Patients With Moyamoya Disease — PBM

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms