Chronic Cerebral IschemiaNCT07711457
Application of Extended Reality (XR)-Assisted Computed Tomography (CT)-Guided Localization in Extracranial-intracranial (EC-IC) Bypass Surgery
An observational study of Chronic Cerebral Ischemia and Moyamoya Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This study will evaluate the application of a metaverse-based surgical simulation platform in extracranial-intracranial (EC-IC) bypass surgery. The study population will include patients with moyamoya disease or chronic cerebral ischemia who are scheduled to undergo EC-IC bypass surgery. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Cerebral Ischemia, Moyamoya Disease, Bypass Surgery
- What is being tested?
- NTU OpVerse surgical simulation platform
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Jun 2026to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include adult patients diagnosed with ischemic moyamoya disease, moyamoya syndrome, or chronic intracranial internal carotid artery stenosis or occlusion who are scheduled to undergo extracranial-intracranial bypass surgery. Eligible procedures include STA-MCA bypass, STA trunk-graft-MCA bypass, and other cerebral revascularization procedures using the superficial temporal artery or another branch of the external carotid artery as the donor vessel. Patients requiring emergency surgery, those with contraindications to CT imaging, severe systemic illness precluding follow-up assessment, scalp conditions or anatomical deformities preventing surface registration, or unreliable XR registration that may compromise surgical safety will be excluded.
Who may be able to join
- Adult patients diagnosed with ischemic moyamoya disease, moyamoya syndrome, or chronic intracranial internal carotid artery stenosis or occlusion (chronic ICA stenosis/occlusion).
- Patients scheduled to undergo extracranial-intracranial bypass surgery (EC-IC bypass), including superficial temporal artery-middle cerebral artery bypass (STA-MCA bypass), superficial temporal artery trunk-interposition graft-middle cerebral artery bypass (STA trunk-graft-MCA bypass), or other cerebral revascularization procedures using the superficial temporal artery or another branch of the external carotid artery system (STA/ECA system) as the donor blood supply.
Who cannot join
- Presence of a contraindication to computed tomography (CT) scanning.
- Presence of a severe systemic illness that would prevent participation in subsequent study assessments, such as poorly controlled diabetes mellitus, active malignancy, or severe cardiac disease.
- The need for emergency surgery without sufficient time to complete image-based modeling and registration.
- Presence of scalp lesions, wounds, or anatomical deformities that prevent reliable surface registration.
- The XR registration result is considered unreliable by the research team and may potentially compromise surgical safety.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
About this study
Official title: Application of Extended Reality (XR)-Assisted CT-Guided Localization in Extracranial-intracranial (EC-IC) Bypass Surgery
This study will evaluate the application of a metaverse-based surgical simulation platform in extracranial-intracranial (EC-IC) bypass surgery. The study population will include patients with moyamoya disease or chronic cerebral ischemia who are scheduled to undergo EC-IC bypass surgery.
Before surgery, preoperative brain computed tomography images will be imported into the metaverse surgical simulation platform. During surgery, extended reality technology will be used to provide precise localization of the relevant vessels, including both the donor and recipient arteries.
The primary objective is to assess the localization accuracy of this platform. The study will also investigate whether this technology can facilitate a minimally invasive surgical approach and improve surgical safety.
- Conditions
- Chronic Cerebral Ischemia, Moyamoya Disease, Bypass Surgery, Augmented Reality, Extended Reality (XR)
- Being tested
- NTU OpVerse surgical simulation platform
- Medical subject headings
- Moyamoya Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NTU OpVerse surgical simulation platformDevice
NTU OpVerse is a patient-specific metaverse-based surgical simulation and assistance platform developed through collaboration among National Taiwan University Hospital, National Taiwan University, and technology partners. The platform integrates medical-image processing, three-dimensional reconstruction, digital-twin technology, and extended reality, including virtual, augmented, and mixed-reality applications.
Patient-specific computed tomography or magnetic resonance imaging data can be imported into the platform and reconstructed into interactive three-dimensional anatomical models. These models allow surgeons to visualize the spatial relationships among target lesions, blood vessels, organs, bones, and other relevant anatomical structures. Through an immersive extended-reality interface, surgeons can manipulate the reconstructed models, examine them from different perspectives, and conduct individualized preoperative planning and procedural simulation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of XR-Assisted Superficial Temporal Artery Localization
Accuracy will be assessed as the absolute distance, measured in millimeters, between the superficial temporal artery location marked using the XR-assisted surgical planning system and the actual superficial temporal artery location identified by vascular ultrasonography. The mean absolute distance error across participants will be reported.
Measured: During preoperative surgical planning and intraoperative confirmation on the day of surgery.
Accuracy of XR-Assisted Middle Cerebral Artery Recipient-Vessel Prediction
Accuracy will be assessed as the absolute distance, measured in millimeters, between the anastomosis site predicted using the XR-assisted surgical planning system and the actual recipient-vessel anastomosis site selected intraoperatively. The mean absolute distance error across participants will be reported.
Measured: From preoperative surgical planning to intraoperative selection of the recipient vessel on the day of surgery.
Secondary outcomes (12)
XR-Assisted STA Localization Time
The time required to localize and mark the superficial temporal artery and middle cerebral artery using the XR-assisted system will be measured in minutes, from initiation of XR registration and localization to completion of skin marking.
Measured: During preoperative preparation on the day of surgery.
Time From Skin Incision to Identification of the Recipient Vessel
The time from the initial skin incision to intraoperative identification of the middle cerebral artery recipient vessel selected for bypass will be measured in minutes.
Measured: During the surgical procedure on the day of surgery.
Total Operative Time
Total operative time will be measured in minutes, from the initial skin incision to completion of skin closure.
Measured: During the surgical procedure on the day of surgery.
Skin-Incision Length
The length of the final skin incision will be measured in centimeters after completion of the surgical procedure.
Measured: At completion of skin closure on the day of surgery.
Maximum Craniotomy Diameter
The maximum diameter of the completed craniotomy will be measured in centimeters intraoperatively.
Measured: During the surgical procedure on the day of surgery.
Intraoperative Enlargement of the Planned Craniotomy
The number and percentage of participants requiring intraoperative enlargement of the craniotomy beyond the preoperatively planned dimensions will be reported.
Measured: During the surgical procedure on the day of surgery.
Intraoperative Bypass Blood Flow
Blood flow through the completed bypass will be measured in milliliters per minute using an intraoperative flow-measurement device after completion of the anastomosis.
Measured: Immediately after completion of the bypass anastomosis on the day of surgery.
Postoperative Ischemic Complications
The number and percentage of participants experiencing a new postoperative cerebral ischemic event, including transient ischemic attack or ischemic stroke, will be reported. Events will be determined by neurological assessment and clinically indicated neuroimaging.
Measured: From completion of surgery through 30 days after surgery.
Postoperative Hemorrhagic Complications
The number and percentage of participants experiencing a new postoperative intracranial hemorrhagic complication will be reported. Events will be determined by neurological assessment and postoperative neuroimaging
Measured: From completion of surgery through 30 days after surgery.
Change in Modified Rankin Scale Score
The change in modified Rankin Scale score will be calculated as the postoperative score minus the preoperative baseline score. The modified Rankin Scale ranges from 0 to 6, with higher scores indicating greater disability.
Measured: From baseline before surgery to 30 days after surgery.
Length of Intensive Care Unit Stay
The duration of postoperative intensive care unit stay will be measured in days, from admission to the intensive care unit after surgery to transfer out of the intensive care unit.
Measured: From completion of surgery through discharge from the intensive care unit, up to 30 days after surgery.
Total Length of Hospital Stay
The total postoperative hospital stay will be measured in days, from the date of surgery to the date of hospital discharge.
Measured: From the date of surgery through hospital discharge, up to 30 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start26 Jun 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Cerebral IschemiaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07711457
- Sponsor's protocol ID
- 202605074RINB
- Status last verified
- Jun 2026
- First submitted
- 14 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Saemann A, de Wilde D, Guzman R, Soleman J, Greuter L. Augmented and Virtual Reality in Open Neurovascular Surgery: A Systematic Review of the Literature. World Neurosurg. 2026 Jan;205:124632. doi: 10.1016/j.wneu.2025.124632. Epub 2025 Nov 6.
PubMed 41205868Bhatia S, Huynh A, Shanahan RM, Kann MR, Gopakumar A, Sharma N, Kass NM, Hurt G, Basdeo R, Don N, Lang MJ, Biehl JT, Andrews EG. Optimizing the Workflow of Superficial Temporal Artery Mapping in Extracranial-Intracranial Bypass Surgery Using Mixed Reality: A Proof-of-Concept Study. World Neurosurg. 2025 Dec;204:124562. doi: 10.1016/j.wneu.2025.124562. Epub 2025 Oct 13.
PubMed 41093253
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Extended Reality (XR)-Assisted CT-Guided Localization in Extracranial-intracranial (EC-IC) Bypass Surgery
- ClinicalTrials.gov ID
- NCT07711457
- Acronym / sponsor ID
- 202605074RINB
- Conditions
- Chronic Cerebral Ischemia, Moyamoya Disease, Bypass Surgery, Augmented Reality, Extended Reality (XR)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 26 Jun 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the application of a metaverse-based surgical simulation platform in extracranial-intracranial (EC-IC) bypass surgery. The study population will include patients with moyamoya disease or chronic cerebral ischemia who are scheduled to undergo EC-IC bypass surgery.
Before surgery, preoperative brain computed tomography images will be imported into the metaverse surgical simulation platform. During surgery, extended reality technology will be used to provide precise localization of the relevant vessels, including both the donor and recipient arteries.
The primary objective is to assess the localization accuracy of this platform. The study will also investigate whether this technology can facilitate a minimally invasive surgical approach and improve surgical safety.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include adult patients diagnosed with ischemic moyamoya disease, moyamoya syndrome, or chronic intracranial internal carotid artery stenosis or occlusion who are scheduled to undergo extracranial-intracranial bypass surgery. Eligible procedures include STA-MCA bypass, STA trunk-graft-MCA bypass, and other cerebral revascularization procedures using the superficial temporal artery or another branch of the external carotid artery as the donor vessel. Patients requiring emergency surgery, those with contraindications to CT imaging, severe systemic illness precluding follow-up assessment, scalp conditions or anatomical deformities preventing surface registration, or unreliable XR registration that may compromise surgical safety will be excluded.
Key inclusion criteria (2 listed)
- Adult patients diagnosed with ischemic moyamoya disease, moyamoya syndrome, or chronic intracranial internal carotid artery stenosis or occlusion (chronic ICA stenosis/occlusion).
- Patients scheduled to undergo extracranial-intracranial bypass surgery (EC-IC bypass), including superficial temporal artery-middle cerebral artery bypass (STA-MCA bypass), superficial temporal artery trunk-interposition graft-middle cerebral artery bypass (STA trunk-graft-MCA bypass), or other cerebral revascularization procedures using the superficial temporal artery or another branch of the external carotid artery system (STA/ECA system) as the donor blood supply.
Key exclusion criteria (5 listed)
- Presence of a contraindication to computed tomography (CT) scanning.
- Presence of a severe systemic illness that would prevent participation in subsequent study assessments, such as poorly controlled diabetes mellitus, active malignancy, or severe cardiac disease.
- The need for emergency surgery without sufficient time to complete image-based modeling and registration.
- Presence of scalp lesions, wounds, or anatomical deformities that prevent reliable surface registration.
- The XR registration result is considered unreliable by the research team and may potentially compromise surgical safety.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NTU OpVerse surgical simulation platformNTU OpVerse is a patient-specific metaverse-based surgical simulation and assistance platform developed through collaboration among National Taiwan University Hospital, National Taiwan University, and technology partners. The platform integrates medical-image processing, three-dimensional reconstruction, digital-twin technology, and extended reality, including virtual, augmented, and mixed-reality applications. Patient-specific computed tomography or magnetic resonance imaging data can be imported into the platform and reconstructed into interactive three-dimensional anatomical models. These models allow surgeons to visualize the spatial relationships among target lesions, blood vessels, organs, bones, and other relevant anatomical structures. Through an immersive extended-reality interface, surgeons can manipulate the reconstructed models, examine them from different perspectives, and conduct individualized preoperative planning and procedural simulation. | Device | – |
Primary outcome
Accuracy of XR-Assisted Superficial Temporal Artery Localization
Time frame: During preoperative surgical planning and intraoperative confirmation on the day of surgery.
Accuracy will be assessed as the absolute distance, measured in millimeters, between the superficial temporal artery location marked using the XR-assisted surgical planning system and the actual superficial temporal artery location identified by vascular ultrasonography. The mean absolute distance error across participants will be reported.
Accuracy of XR-Assisted Middle Cerebral Artery Recipient-Vessel Prediction
Time frame: From preoperative surgical planning to intraoperative selection of the recipient vessel on the day of surgery.
Accuracy will be assessed as the absolute distance, measured in millimeters, between the anastomosis site predicted using the XR-assisted surgical planning system and the actual recipient-vessel anastomosis site selected intraoperatively. The mean absolute distance error across participants will be reported.
12 secondary outcomes
XR-Assisted STA Localization Time
Time frame: During preoperative preparation on the day of surgery.
Time From Skin Incision to Identification of the Recipient Vessel
Time frame: During the surgical procedure on the day of surgery.
Total Operative Time
Time frame: During the surgical procedure on the day of surgery.
Skin-Incision Length
Time frame: At completion of skin closure on the day of surgery.
Maximum Craniotomy Diameter
Time frame: During the surgical procedure on the day of surgery.
Intraoperative Enlargement of the Planned Craniotomy
Time frame: During the surgical procedure on the day of surgery.
Intraoperative Bypass Blood Flow
Time frame: Immediately after completion of the bypass anastomosis on the day of surgery.
Postoperative Ischemic Complications
Time frame: From completion of surgery through 30 days after surgery.
Postoperative Hemorrhagic Complications
Time frame: From completion of surgery through 30 days after surgery.
Change in Modified Rankin Scale Score
Time frame: From baseline before surgery to 30 days after surgery.
Length of Intensive Care Unit Stay
Time frame: From completion of surgery through discharge from the intensive care unit, up to 30 days after surgery.
Total Length of Hospital Stay
Time frame: From the date of surgery through hospital discharge, up to 30 days after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Results publication: PubMed 41205868Saemann A, de Wilde D, Guzman R, Soleman J, Greuter L. Augmented and Virtual Reality in Open Neurovascular Surgery: A Systematic Review of the Literature. World Neurosurg. 2026 Jan;205:124632. doi: 10.1016/j.wneu.2025.124632. Epub 2025 Nov 6.
- Results publication: PubMed 41093253Bhatia S, Huynh A, Shanahan RM, Kann MR, Gopakumar A, Sharma N, Kass NM, Hurt G, Basdeo R, Don N, Lang MJ, Biehl JT, Andrews EG. Optimizing the Workflow of Superficial Temporal Artery Mapping in Extracranial-Intracranial Bypass Surgery Using Mixed Reality: A Proof-of-Concept Study. World Neurosurg. 2025 Dec;204:124562. doi: 10.1016/j.wneu.2025.124562. Epub 2025 Oct 13.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Cerebral Ischemia and Moyamoya Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chiu Hao Hsu (88623123456 ext. 73234, newmanhsu0814@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of XR-Assisted Superficial Temporal Artery Localization (time frame: During preoperative surgical planning and intraoperative confirmation on the day of surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07711457, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.