Ischaemic Heart DiseaseIntegration-IINCT03646097
Impact of Real-time Angiographic Co-registered OCT on PCI Results - the OPTICO-integration II Study
A study testing Angio-PCI, OCT-PCI and ACR-PCI in people with Ischaemic Heart Disease, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ischaemic Heart Disease
- What is being tested?
- Angio-PCI, OCT-PCI and ACR-PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteGermany
- Study dates
- 21 Aug 2018to 15 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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%.
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Real-time Angiographic Co-registered OCT on PCI Results - the Randomized OPTICO-integration II Study
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)
Read the 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
- Being tested
- Angio-PCI, OCT-PCI, ACR-PCI
- Keywords
- OCT, Co-Registration, Stent, PCI, Geographical mismatch, Edge Dissection
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angio-PCIProcedure or surgery
PCI only with angiography and without OCT findings
OCT-PCIProcedure or surgery
PCI with OCT-measurements but no transfer of landingzone-markers to angiography
ACR-PCIProcedure or surgery
PCI with OCT-measurements and transfer of landingzone-markers to angiography
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: 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 Receives: Procedure: ACR-PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- 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:
- the segment of the lesion is fully covered AND
- the stent protrudes maximal 5mm beyond the predetermined landing zone.
If one of these criteria is not fulfilled, it is considered as geographical mismatch
Measured: 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" [%]
All secondary endpoints of OCT will be assessed by evaluation of proximal and/or distal stent end/segment.
Measured: 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)) [%]
(I) ≥60 degrees of the circumference of the vessel at site of dissection and/or ≥3 mm in length (II) Any visible edge dissection <60 degrees of the circumference of the vessel and < 3 mm in length
Measured: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Incidence of "geographical mismatch" [%]
see primary endpoint
Measured: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Stent expansion [%]
Defined by the MSA achieved relative to the proximal or distal reference segments.
The stent length is divided into 2 equal segments (proximal and distal), and the MSA is determined in each segment.
- Optimal stent expansion: The MSA of the segment is ≥95% of the related reference lumen area
- Acceptable stent expansion: The MSA of the segment is ≥90% and <95% of the related reference lumen area
- Unacceptable stent expansion: The MSA of the segment is <90% of the related lumen area
Measured: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Inacceptable stent expansion [%]
see outcome 5
Measured: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Incidence of "malapposition" [%]
Incompletely apposed stent struts in at least 5 consecutive OCT-frames (defined as stent struts clearly separated from the vessel wall (lumen border/plaque border) without any tissue behind the struts with a distance from the adjacent intima of ≥0.2 mm and not associated with any side branch).
Malapposition will be further classified as:
- Major: If associated with stent underexpansion (unacceptable stent expansion as defined above) B) Minor: If not associated with significant underexpansion (optimal or acceptable stent expansion as defined above) C) Major and minor
Measured: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Distance between target and actual lesion coverage [mm]
Defined as the distance between target landing zone and actual landing zone of stent location (proximal and distal end). Therefore, the lesion is divided in two equal halves, so that every segment (proximal and distal) can be analyzed for itself.
Measured: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Minimal Stent Area (MSA) of target lesion [%]
Minimal lumen area covered by stent.
Measured: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Acute Luminal Gain of target lesion [mm]
Gain of Minimal Lumen Diameter (MLD) between prePCI- and postPCI-OCT
Measured: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Procedure time [min]
Time from reaching the ostium with the guide catheter until pullback of the last one.
Measured: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Total fluoroscopy time [min]
Total time required for diagnostic angiography and PCI.
Measured: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Total contrast volume [ml]
Total amount of contrast used for entire intervention (including OCT-pullbacks)
Measured: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Total stent length [mm]
Addition of each stent length which were used for target lesion
Measured: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Total number of stents
Number of stents which were used for target lesion
Measured: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Maximal stent diameter [mm]
Maximal stent diameter used for target lesion
Measured: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Complications associated with OCT-examination [%]
Complications between advancing and pullback of OCT catheter
Measured: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Complications during hospitalization [%]
Defined as: new ACS; stent thrombosis of study culprit lesion; new unplaned coronary angiography; new revascularization (PCI/CABG); apoplex/TIA; pacemaker implantation; anaphylactic shock; contrast-induced nephropathy; bleeding; death
Measured: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
DOCE within target lesion [%]
Device-oriented composite endpoint within the target lesion. Defined as cardiovascular death, myocardial infarction OR target-lesion revascularization. This composite endpoint will be checked during a follow up after 1 and 3 months.
Measured: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start21 Aug 2018
- Primary completion29 Nov 2018
- Study completion15 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischaemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Manuel Leistner, Charite University, Berlin, Germany
- Investigators
- David M Leistner, PD Dr. med., Principal investigator, Managing Senior Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03646097
- Sponsor's protocol ID
- OPTICO-Integration II
- Acronym
- Integration-II
- Status last verified
- Apr 2019
- First submitted
- 5 Aug 2018
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Real-time Angiographic Co-registered OCT on PCI Results - the Randomized OPTICO-integration II Study
- ClinicalTrials.gov ID
- NCT03646097
- Acronym / sponsor ID
- Integration-II / OPTICO-Integration II
- Conditions
- Ischaemic Heart Disease
- Keywords
- OCT, Co-Registration, Stent, PCI, Geographical mismatch, Edge Dissection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 21 Aug 2018 (actual)
- Primary completion
- 29 Nov 2018 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 24 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Blinded-group | Active comparator | Procedure: Angio-PCILesion assessment, selection of PCI landing zone as well as stent selection will be performed by investigators only based on angiographic lesion evaluation (standard care) |
| OCT-group | Active comparator | Procedure: OCT-PCIPatients 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 |
| ACR-group | Experimental | Procedure: ACR-PCIPatients 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Angio-PCIPCI only with angiography and without OCT findings | Procedure or surgery | Blinded-group |
| OCT-PCIPCI with OCT-measurements but no transfer of landingzone-markers to angiography | Procedure or surgery | OCT-group |
| ACR-PCIPCI with OCT-measurements and transfer of landingzone-markers to angiography | Procedure or surgery | ACR-group |
Primary outcome
Incidence of a combined endpoint based on "major edge dissections" (I) AND/OR "geographical mismatch" (II) [%]
Time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
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
18 secondary outcomes
Incidence of "major edge dissections" [%]
Time frame: 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 frame: 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 frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Stent expansion [%]
Time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Inacceptable stent expansion [%]
Time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Incidence of "malapposition" [%]
Time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Distance between target and actual lesion coverage [mm]
Time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Minimal Stent Area (MSA) of target lesion [%]
Time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Acute Luminal Gain of target lesion [mm]
Time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Procedure time [min]
Time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Total fluoroscopy time [min]
Time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Total contrast volume [ml]
Time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Total stent length [mm]
Time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Total number of stents
Time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Maximal stent diameter [mm]
Time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Complications associated with OCT-examination [%]
Time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Complications during hospitalization [%]
Time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
DOCE within target lesion [%]
Time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Ischaemic Heart Disease
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
RecruitingEarly Phase 1
Thiamine Intervention and Coronary Artery Bypass Grafting
Coronary Heart Disease, Coronary Artery Bypass Grafting
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David M Leistner, PD Dr. med. principal investigator
Managing Senior Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Angio-PCI, OCT-PCI and ACR-PCI in people with Ischaemic Heart Disease, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of a combined endpoint based on "major edge dissections" (I) AND/OR "geographical mismatch" (II) [%] (time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2019.