Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05377866
Other study ID # HoloCTO
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 4, 2021
Est. completion date January 31, 2023

Study information

Verified date September 2021
Source Sorlandet Hospital HF
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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 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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date January 31, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • Chronic Total Occlusion of Coronary Artery
  • Percutaneous Coronary Intervention

Intervention

Other:
Remote proctoring using HoloLens
Assess Microsoft HoloLens as an interactive communication device in remote proctoring, and enhancement of teamwork in complex CTO procedures.

Locations

Country Name City State
Norway Sorlandet Hospital Arendal Agder

Sponsors (3)

Lead Sponsor Collaborator
Sorlandet Hospital HF HoloCare AS, Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
See also
  Status Clinical Trial Phase
Terminated NCT03959072 - Cardiac Cath Lab Staff Radiation Exposure
Not yet recruiting NCT05669222 - The FAVOR V AMI Trial N/A
Recruiting NCT04566497 - Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up. N/A
Recruiting NCT05240781 - Zotarolimus vs Sirolimus Eluting Stent in High Bleeding Risk N/A
Recruiting NCT03378934 - Anti-platelet Effect of Berberine in Patients After Percutaneous Coronary Intervention Phase 4
Not yet recruiting NCT06025071 - Residual Inflammatory Risk-Guided colcHicine in Elderly Trial Phase 4
Withdrawn NCT04043091 - Coronary Angiography in Critically Ill Patients With Type II Myocardial Infarction N/A
Completed NCT02837744 - Studying Hemostatic Effect of Axiostat® Dressing on Radial Access After Percutaneous Procedure
Completed NCT03085823 - The All-comers Sirolimus-coated Balloon European Registry
Completed NCT02044146 - A Pharmacodynamic Study of a Personalized Strategy for P2Y12 Inhibition Versus Ticagrelor in Reducing Ischemic and Bleeding Risk Phase 2/Phase 3
Completed NCT03131271 - Effect of Ice Bag Application to Femoral Region on Pain in Patients Undergoing Percutaneous Coronary Intervention N/A
Completed NCT01135667 - Prasugrel Versus Double Dose Clopidogrel to Treat Clopidogrel Low-responsiveness After PCI Phase 4
Completed NCT01156571 - A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention (PCI) (CHAMPION PHOENIX) Phase 3
Unknown status NCT00751491 - Clopidogrel Versus Adenosin in Non Urgent Percutaneous Coronary Intervention (PCI) Phase 3
Completed NCT00725868 - Blood Endothelium Biomarkers to Predict Major Adverse Cardiovascular Events After Percutaneous Coronary Intervention N/A
Completed NCT03708588 - Chewed Versus Integral Pill of Ticagrelor Phase 4
Completed NCT04163393 - R-One Efficiency For PCI Evolution With Robotic Assistance N/A
Recruiting NCT05554588 - Intrathrombus Thrombolysis Versus Aspiration Thrombectomy During Primary PCI N/A
Recruiting NCT06080919 - Plaque Modification And Impact On Microcirculatory Territory After Drug-Coated Balloon Percutaneous Coronary Intervention (PLAMI). N/A
Recruiting NCT05353140 - LAAO Versus NOAC in Patients With AF and PCI N/A