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

NCT03646097 | Completed

• 1 other identifier: OPTICO-Integration II
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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)

Conditions

Ischaemic Heart Disease

Keywords

OCT; Co-Registration; Stent; PCI; Geographical mismatch; Edge Dissection

Outcome Measures

Primary Outcomes (1)

• Incidence of a combined endpoint based on "major edge dissections" (I) AND/OR "geographical mismatch" (II) [%]

  Analysis of primary endpoint will be assessed by evaluation of proximal and/or distal stent end. I) Major edge dissection (MED): Major: ≥60 degrees of the circumference of the vessel at site of dissection and/or ≥3 mm in length II) Geographical mismatch (GM): Untreated plaque with a minimal lumen area \<4,5mm2 within 5mm of the reference segment. In the postPCI-OCT analysis it is considered as no geographical mismatch, if: 1. the segment of the lesion is fully covered AND 2. the stent protrudes maximal 5mm beyond the predetermined landing zone. If one of these criteria is not fulfilled, it is considered as geographical mismatch

  Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours

Secondary Outcomes (18)

• Incidence of "major edge dissections" [%]

  Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours

• Incidence of "all edge dissections" (major (I) and minor (II)) [%]

  Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours

• Incidence of "geographical mismatch" [%]

  Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours

• Stent expansion [%]

  Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours

• Inacceptable stent expansion [%]

  Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours

Study Arms (3)

Blinded-group

ACTIVE COMPARATOR

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)

Procedure: Angio-PCI

OCT-group

ACTIVE COMPARATOR

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

Procedure: OCT-PCI

ACR-group

EXPERIMENTAL

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

Procedure: ACR-PCI

Interventions

Angio-PCI PROCEDURE

PCI only with angiography and without OCT findings

Blinded-group

OCT-PCI PROCEDURE

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

OCT-group

ACR-PCI PROCEDURE

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

ACR-group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, 12203, Germany

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• David M Leistner, PD Dr. med.

  Managing Senior Physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med., Principal Investigator

Study Record Dates

• First Submitted: August 5, 2018
• First Posted: August 24, 2018
• Study Start: August 21, 2018
• Primary Completion: November 29, 2018
• Study Completion: March 15, 2019
• Last Updated: April 23, 2019

Record last verified: 2019-04

Locations

DE (1)