NCT03646097

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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)

Detailed description

In this randomized blinded pilot-study the effect of pre-PCI planning by angiographic-co-registered OCT (ACR) compared to OCT or angiographic evaluation alone with respect to the entire result after PCI will be investigated. A special focus (primary endpoint) will be on the incidence of geographical mismatch (GM) and/or major edge dissections. Eligible patients will be randomized in three groups. Group 1 Pre-PCI-OCT: Patients underwent OCT-imaging before PCI. Lesion assessment, selection of PCI landing zone as well as stent selection will be performed by investigators based on OCT findings. Group 2: Pre-PCI-ACR: Patients underwent ACR-imaging before PCI. Lesion assessment, selection of PCI landing zone as well as stent selection will be performed by investigators based on ACR-findings. Group 3:OCT-Blinded/Angiographic guided PCI: Lesion assessment, selection of PCI landing zone as well as stent selection will be performed by investigators only based on angiographic lesion evaluation (standard care). For outcome analysis all study groups underwent post-PCI-OCT imaging as soon as investigators assume angiographic justiciable PCI-results (TIMI III, no residual stenosis \> 50%; no angiographic definable or suspicious edge dissections, angiographic acceptable stent expansion without evidence for malapposition). OCT imaging analysis will be performed within a OCT core-lab by two investigators blinded for the randomization group.

Conditions

• Ischaemic Heart Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-08-21
• Primary completion: 2018-11-29
• Completion: 2019-03-15
• First posted: 2018-08-24
• Last updated: 2019-04-23

Locations

1 site across 1 country: Germany