Holo CTO Proctoring Study

Study Overview
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Brief Summary
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Assess Microsoft HoloLens as an interactive communication device in remote proctoring, and enhancement of teamwork in complex CTO procedures

Detailed Description
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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 complex. Most likely, proctoring together with operator volume is one of the foundations to the introduction and execution of CTO procedures. Proctoring traditionally involves an expert operator (proctor), visiting the institution, performing the procedure together with the local operator. This involves increased cost, and current travel restrictions makes traditional one-on-one proctoring challenging. This study aims to evaluate the Microsoft HoloLens as a potential platform in proctoring and effective real time communication between PCI operators located at different geographical locations. The proctor and the local operator interact using a head mounted mixed reality (MR) display, enabling the proctor to see the same image as the operator, from any distanced location.

Official Title
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Holo CTO Proctoring Study

Conditions
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Percutaneous Coronary Intervention, Chronic Total Occlusion of Coronary Artery

Intervention / Treatment
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* Other: Remote proctoring using HoloLens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study population<br>Patients undergoing percutaneus coronary intervention for chronic total occlusion. The procedures will all be done using mixed reality to enable remote proctoring. The study is a feasibility trial. | Other: Remote proctoring using HoloLens<br>* Assess Microsoft HoloLens as an interactive communication device in remote proctoring, and enhancement of teamwork in complex CTO procedures.<br>* Other names: Chronic total occlusion percutaneus coronary intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standard Usability Score on a Likert Scale | The operators completing the intervention will rate the usability of the system on a Likert scale: The HoloLens was useful in this procedure The HoloLens was not distracting The HoloLens was comfortable to wear The HoloLens camera image has sufficient quality for clinical use (not considering the fluoroscopy screen) Compared to an alternative system with fluoroscopy image plus handsfree voice (telephone), the HoloLens gives additional value during the procedure The current solution with Remote Assist plus parallel fluoroscopy streaming is mature enough for routine use The current solution is stable The current solution is easy to set up prior to the procedure I would like to continue to use the HoloLens in CTO procedures routinely when remote proctoring is needed Agree to Disagree Likert Scale Strongly Disagree Disagree Neither agree nor disagree Agree Strongly Agree | Procedure duration( aprox 120 min) |