Clinical trial NCT03646097: Impact of Real-time Angiographic Co-registered OCT on PCI Results - the OPTICO-integration II Study
Official title: Impact of Real-time Angiographic Co-registered OCT on PCI Results - the Randomized OPTICO-integration II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischaemic Heart Disease
Keywords: OCT
Co-Registration
Stent
PCI
Geographical mismatch
Edge Dissection
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence of a combined endpoint based on "major edge dissections" (I) AND/OR "geographical mismatch" (II) [%]
timeFrame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Secondary outcomes:
measure: Incidence of "major edge dissections" [%]
timeFrame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
measure: Incidence of "all edge dissections" (major (I) and minor (II)) [%]
timeFrame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
measure: Incidence of "geographical mismatch" [%]
timeFrame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
measure: Stent expansion [%]
timeFrame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
measure: Inacceptable stent expansion [%]
timeFrame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
measure: Incidence of "malapposition" [%]
timeFrame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
measure: Distance between target and actual lesion coverage [mm]
timeFrame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
measure: Minimal Stent Area (MSA) of target lesion [%]
timeFrame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
measure: Acute Luminal Gain of target lesion [mm]
timeFrame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
measure: Procedure time [min]
timeFrame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
measure: Total fluoroscopy time [min]
timeFrame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
measure: Total contrast volume [ml]
timeFrame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
measure: Total stent length [mm]
timeFrame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
measure: Total number of stents
timeFrame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
measure: Maximal stent diameter [mm]
timeFrame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
measure: Complications associated with OCT-examination [%]
timeFrame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
measure: Complications during hospitalization [%]
timeFrame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
measure: DOCE within target lesion [%]
timeFrame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Managing Senior Physician
name: David M Leistner, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: