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

NCT ID: NCT03646097

Last Updated: 2019-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-21
• Study Completion Date: 2019-03-15

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Blinded-group

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)

Group Type: ACTIVE_COMPARATOR

Angio-PCI

Intervention Type: PROCEDURE

PCI only with angiography and without OCT findings

OCT-group

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 Type: ACTIVE_COMPARATOR

OCT-PCI

Intervention Type: PROCEDURE

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

ACR-group

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 Type: EXPERIMENTAL

ACR-PCI

Intervention Type: PROCEDURE

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

Interventions

Angio-PCI

PCI only with angiography and without OCT findings

Intervention Type: PROCEDURE

OCT-PCI

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

Intervention Type: PROCEDURE

ACR-PCI

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patient with indication for coronary angiography for angina (stable or unstable), silent ischemia (a visually estimated target lesion diameter stenosis of ≥70%, a positive invasive or non-invasive test must be present), or NSTE-ACS
• male or non pregnant female patient
• Signed written informed consent

Exclusion Criteria

• Known neoplasia on treatment / without a curative therapeutic approach
• Presence of one or more co-morbidities which reduces life expectancy to less than 24 months
• Estimated creatinine clearance <40 ml/min
• Cardiogenic shock
• Hemodynamic instability because of arrhythmia
• Known left ventricular ejection fraction (LVEF) <30%.
• Therapy requiring psychiatric disorder
• Patient is participating in any other investigational drug or device clinical trial that has not reached its primary endpoint.
• Women who are pregnant or breastfeeding
• Refusal of study participation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

David Manuel Leistner

PD Dr. med., Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David M Leistner, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Managing Senior Physician

Locations

Charité - Universitätsmedizin Berlin

Berlin, , Germany

Countries

Germany

Other Identifiers

OPTICO-Integration II

Identifier Type: -

Identifier Source: org_study_id