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