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Impact of Real-time Angiographic Co-registered OCT on PCI Results - the OPTICO-integration II Study

NCT03646097 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2019-04-23

No results posted yet for this study

Summary

Intracoronary optical coherence tomography (OCT) imaging allows for high-resolution characterization of coronary lesions. Difficulties in matching cross-sectional OCT-images with angiographic lesion localization, however, may limit its clinical utilization. The investigators sought to prospectively assess the impact of a novel system of real-time OCT-coregistration with angiography (ACR) compared to OCT alone and to the clinical standard proceeding (angiographic guided-PCI) all used for coronary lesion evaluation before percutaneous coronary interventions (PCI). The investigators hypothesize that the use of ACR will lead to less incidence of insufficient covered coronary lesions (geographical mismatch) and/or a less rate of edge dissections after PCI (combined primary study endpoint)

Conditions

  • Ischaemic Heart Disease

Interventions

PROCEDURE

Angio-PCI

PCI only with angiography and without OCT findings

PROCEDURE

OCT-PCI

PCI with OCT-measurements but no transfer of landingzone-markers to angiography

PROCEDURE

ACR-PCI

PCI with OCT-measurements and transfer of landingzone-markers to angiography

Sponsors & Collaborators

  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • David M Leistner, PD Dr. med. · Managing Senior Physician

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-21
Primary Completion
2018-11-29
Completion
2019-03-15

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03646097 on ClinicalTrials.gov