Status:
COMPLETED
Holo CTO Proctoring Study
Lead Sponsor:
Sorlandet Hospital HF
Collaborating Sponsors:
Oslo University Hospital
HoloCare AS
Conditions:
Percutaneous Coronary Intervention
Chronic Total Occlusion of Coronary Artery
Eligibility:
All Genders
18+ years
Brief Summary
Assess Microsoft HoloLens as an interactive communication device in remote proctoring, and enhancement of teamwork in complex CTO procedures
Detailed Description
Proctoring in medicine is related to better outcomes. Specifically, in CTO PCI systematic proctoring has demonstrated improved success rates, and an increased ability to treat lesions that are more co...
Eligibility Criteria
Inclusion
- Clinical inclusion criteria:
- Stable angina pectoris, or dyspnoea as an angina equivalent
- Age ≥18 yrs.
- Able to provide written informed consent
- Angiographic inclusion criteria:
- One or more completely occluded coronary arteries with Thrombolysis In Myocardial Infarction (TIMI) flow 0. An estimated occlusion duration of at least 3 months
- Absence of Q-wave in ECG leads corresponding to the occluded vessel, or documented viability of the main territory by MRI or echocardiography
- Procedural inclusion criteria:
- Clinical indication for CTO PCI regardless of operative technique
Exclusion
- STEMI within 72 hours
- Cardiogenic shock
- Active bleeding or coagulopathy
- Life expectancy \< 2 years
- Relevant allergies (aspirin, clopidrogrel, ticagrelol, contrast compounds)
- Severe peripheral artery disease
- Clinical unstable angina
Key Trial Info
Start Date :
November 4 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 31 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05377866
Start Date
November 4 2021
End Date
January 31 2023
Last Update
February 1 2023
Active Locations (1)
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1
Sorlandet Hospital
Arendal, Agder, Norway, 4808