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Comparison of Optical Coherence Tomography-derived Minimal Lumen Area, Invasive Fractional Flow Reserve and FFRCT (OPTICO-LM)

Primary Purpose

Coronary Stenosis

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
OCT, FFR, CTA and FFRCT
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Stenosis focused on measuring Coronary artery disease, Fractional flow reserve, Optical coherence tomography, Computed tomography angiography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Unprotected LM lesion [midshaft, and distal bifurcation (Medina 1,1,1 or 1,1,0 or 1,0,1 or 1,0,0)] of 30% to 80% angiographic diameter stenosis (DS) on visual estimation or equivocal disease by angiography.
  • Age ≥18 years.
  • Ability to give preliminary oral consent witnessed by an independent physician or sign written informed consent prior to any study-specific procedures.

Exclusion Criteria:

  • Significant distal lesions (>50% angiographic DS on visual estimation within the left anterior descending artery [LAD] or left circumflex artery [LCX], except for ostium of LAD or LCX or diseased side branch [e.g. diagonal branch, obtuse marginal branch])
  • Ostial LM disease.
  • Acute coronary syndrome (ACS) (non-ST-elevation ACS and ST-elevation MI).
  • LM In-stent restenosis.
  • Previous coronary stenting of the left coronary system.
  • Chronic total occlusion.
  • Previous coronary artery bypass graft.
  • Previous MI related to the left coronary artery.
  • Occurrence of ventricularization or hypotension during engagement of the LM ostial lesion.
  • The presence of hemodynamic instability.
  • Known renal insufficiency (serum creatinine >1.5mg/dL or receiving dialysis).
  • Female of childbearing potential (age <50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy.
  • Life expectancy less than 1 year.
  • Contraindication or known allergy against protocol-required medications including heparin, iodinated contrast, β-blocker, nitroglycerin, and adenosine.
  • Body mass index >35kg/m2.
  • Complex congenital heart disease other than anomalous coronary origins alone.
  • Ventricular septal defect.

Sites / Locations

  • Centre Hospitalier Universitaire de Clermont-FerrandRecruiting
  • Institute Mutualiste MontsourisRecruiting
  • Centre Cardiologique du NordRecruiting
  • Universitätsklinikum Giessen Justus-Liebig UniversitätRecruiting
  • Friedrich Alexander Universität (FAU) , Medizinische Klinik 2 , Kardiologie und AngiologieRecruiting
  • Ageo Central General HospitalRecruiting
  • Gifu heart centerRecruiting
  • Department of Cardiovascular Medicine Shinshu University School of MedicineRecruiting
  • Kansai Medical University,Recruiting
  • Medical Corporation Ouyuukai Tokorozawa Heart CenterRecruiting
  • Sapporo Higashi Tokushukai HospitalRecruiting
  • InselspitalRecruiting
  • CHUVRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patient with left-main stenosis

Arm Description

Multimodality assessment of intermediate left main stenosis: Comparison of optical coherence tomography-derived minimal lumen area, invasive fractional flow reserve and FFRCT

Outcomes

Primary Outcome Measures

OCT vs. FFR
- The area under the curve of OCT-derived MLA for FFR≤0.8
OCT vs. FFR
-The optimal cut-off point of OCT-derived MLA from receiver-operator characteristics curves for FFR≤0.8
FFRCT vs. FFR
Diagnostic accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of FFRCT≤0.8 for FFR≤0.8

Secondary Outcome Measures

OCT vs. FFR, RFR, resting Pd/Pa, FFRCT, QFR
- The area under the curve and the optimal cut-off point of OCT-derived MLA from receiver-operator characteristics curves for FFR≤0.75, RFR≤0.89, resting Pd/Pa≤0.91, and FFRCT≤0.80 and QFR≤0.80
OCT vs. FFR, RFR, resting Pd/Pa, FFRCT
- Predictability of MLA, minimal lumen diameter, area stenosis, lesion length, eccentricity index, and plaque characteristics (plaque rupture, fibroatheroma, and calcification) for FFR ≤0.8, FFR≤0.75, RFR≤0.89, resting Pd/Pa≤0.91, and FFRCT≤0.80 and QFR≤0.80
OCT vs. FFR, RFR, resting Pd/Pa, FFRCT
- Correlation among OCT-derived MLA, FFR, RFR, resting Pd/Pa, and FFRCT and QFR
OCT vs. CTA
- Correlation between luminal diameter stenosis of CTA and OCT-derived MLA
OCT vs. CTA
- Diagnostic accuracy of plaque characteristics with presumed high risk characteristics including napkin ring sign, low attenuation plaque (<30HU), positive remodelling (remodelling index >1.1), and spotty calcium (<3mm) for thin and thick cap fibroatheroma by OCT.
Clinical endpoint at 1 year
Death
Clinical endpoint at 1 year
Myocardial infarction
Clinical endpoint at 1 year
Target vessel myocardial infarction
Clinical endpoint at 1 year
Target lesion revascularization
Clinical endpoint at 1 year
Target vessel revascularization
Clinical endpoint at 1 year
Any revascularization
Clinical endpoint at 1 year
Stent thrombosis
Clinical endpoint at 1 year
Stroke and transient ischemic attack
Clinical endpoint at 1 year
Acute renal failure

Full Information

First Posted
January 17, 2019
Last Updated
February 8, 2023
Sponsor
Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT03820492
Brief Title
Comparison of Optical Coherence Tomography-derived Minimal Lumen Area, Invasive Fractional Flow Reserve and FFRCT
Acronym
OPTICO-LM
Official Title
Multimodality Assessment of Intermediate Left Main Stenosis: Comparison of Optical Coherence Tomography-derived Minimal Lumen Area, Invasive Fractional Flow Reserve and FFRCT
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 28, 2019 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Significant left main (LM) stenosis is associated with a poor prognosis, therefore, adequate judgement of the prognostic significance of LM stenosis is essential to improve patients' prognosis. Recently, fractional flow reserve (FFR) has become widespread practice and carries a Class Ia recommendation to assess functional significance of intermediate coronary stenosis in patients with stable angina. Intravascular ultrasound (IVUS)-derived minimum lumen area (MLA) represents an accurate measure to determine LM significance as shown in multiple studies, while optical coherence tomography (OCT) ,which is a novel intracoronary imaging method with a greater spatial resolution (15μm vs. 100μm), faster image acquisition and facilitated image interpretation, OCT derived-MLA has never been validated against FFR and accordingly, it is not mentioned in the current guidelines for myocardial revascularization. Coronary computed tomography angiography (CTA) has emerged as a noninvasive alternative of coronary angiography with its excellent negative predictive value, while the positive predictive value of CTA is limited. Computational fluid dynamics is an emerging method that enables prediction of blood flow in coronary arteries and calculation of FFR from computed tomography (FFRCT) noninvasively. Noninvasive and accurate assessment of functional significance would bring a great benefit for patients with LM stenosis, however, there are no data to evaluate the diagnostic accuracy of FFRCT for LM stenosis in comparison with FFR and minimal lumen area derived by OCT. This study will investigate the optimal OCT-derived MLA cut-off point and the diagnostic performance of FFRCT for intermediate LM stenosis compared with FFR ≤0.8 as a reference standard.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Stenosis
Keywords
Coronary artery disease, Fractional flow reserve, Optical coherence tomography, Computed tomography angiography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient with left-main stenosis
Arm Type
Other
Arm Description
Multimodality assessment of intermediate left main stenosis: Comparison of optical coherence tomography-derived minimal lumen area, invasive fractional flow reserve and FFRCT
Intervention Type
Diagnostic Test
Intervention Name(s)
OCT, FFR, CTA and FFRCT
Intervention Description
Multimodality assessment of intermediate left main stenosis: Comparison of optical coherence tomography-derived minimal lumen area, invasive fractional flow reserve and FFRCT
Primary Outcome Measure Information:
Title
OCT vs. FFR
Description
- The area under the curve of OCT-derived MLA for FFR≤0.8
Time Frame
Measurement at Procedure/ Baseline Visit
Title
OCT vs. FFR
Description
-The optimal cut-off point of OCT-derived MLA from receiver-operator characteristics curves for FFR≤0.8
Time Frame
Measurement at Procedure/ Baseline Visit
Title
FFRCT vs. FFR
Description
Diagnostic accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of FFRCT≤0.8 for FFR≤0.8
Time Frame
Measurement at Procedure/ Baseline Visit
Secondary Outcome Measure Information:
Title
OCT vs. FFR, RFR, resting Pd/Pa, FFRCT, QFR
Description
- The area under the curve and the optimal cut-off point of OCT-derived MLA from receiver-operator characteristics curves for FFR≤0.75, RFR≤0.89, resting Pd/Pa≤0.91, and FFRCT≤0.80 and QFR≤0.80
Time Frame
Measurement at Procedure/ Baseline Visit
Title
OCT vs. FFR, RFR, resting Pd/Pa, FFRCT
Description
- Predictability of MLA, minimal lumen diameter, area stenosis, lesion length, eccentricity index, and plaque characteristics (plaque rupture, fibroatheroma, and calcification) for FFR ≤0.8, FFR≤0.75, RFR≤0.89, resting Pd/Pa≤0.91, and FFRCT≤0.80 and QFR≤0.80
Time Frame
Measurement at Procedure/ Baseline Visit
Title
OCT vs. FFR, RFR, resting Pd/Pa, FFRCT
Description
- Correlation among OCT-derived MLA, FFR, RFR, resting Pd/Pa, and FFRCT and QFR
Time Frame
Measurement at Procedure/ Baseline Visit
Title
OCT vs. CTA
Description
- Correlation between luminal diameter stenosis of CTA and OCT-derived MLA
Time Frame
Measurement at Procedure/ Baseline Visit
Title
OCT vs. CTA
Description
- Diagnostic accuracy of plaque characteristics with presumed high risk characteristics including napkin ring sign, low attenuation plaque (<30HU), positive remodelling (remodelling index >1.1), and spotty calcium (<3mm) for thin and thick cap fibroatheroma by OCT.
Time Frame
Measurement at Procedure/ Baseline Visit
Title
Clinical endpoint at 1 year
Description
Death
Time Frame
12 Month
Title
Clinical endpoint at 1 year
Description
Myocardial infarction
Time Frame
12 Month
Title
Clinical endpoint at 1 year
Description
Target vessel myocardial infarction
Time Frame
12 Month
Title
Clinical endpoint at 1 year
Description
Target lesion revascularization
Time Frame
12 Month
Title
Clinical endpoint at 1 year
Description
Target vessel revascularization
Time Frame
12 Month
Title
Clinical endpoint at 1 year
Description
Any revascularization
Time Frame
12 Month
Title
Clinical endpoint at 1 year
Description
Stent thrombosis
Time Frame
12 Month
Title
Clinical endpoint at 1 year
Description
Stroke and transient ischemic attack
Time Frame
12 Month
Title
Clinical endpoint at 1 year
Description
Acute renal failure
Time Frame
12 Month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Unprotected LM lesion [midshaft, and distal bifurcation (Medina 1,1,1 or 1,1,0 or 1,0,1 or 1,0,0)] of 30% to 80% angiographic diameter stenosis (DS) on visual estimation or equivocal disease by angiography. Age ≥18 years. Ability to give preliminary oral consent witnessed by an independent physician or sign written informed consent prior to any study-specific procedures. Exclusion Criteria: Significant distal lesions (>50% angiographic DS on visual estimation within the left anterior descending artery [LAD] or left circumflex artery [LCX], except for ostium of LAD or LCX or diseased side branch [e.g. diagonal branch, obtuse marginal branch]) Ostial LM disease. Acute coronary syndrome (ACS) (non-ST-elevation ACS and ST-elevation MI). LM In-stent restenosis. Previous coronary stenting of the left coronary system. Chronic total occlusion. Previous coronary artery bypass graft. Previous MI related to the left coronary artery. Occurrence of ventricularization or hypotension during engagement of the LM ostial lesion. The presence of hemodynamic instability. Known renal insufficiency (serum creatinine >1.5mg/dL or receiving dialysis). Female of childbearing potential (age <50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy. Life expectancy less than 1 year. Contraindication or known allergy against protocol-required medications including heparin, iodinated contrast, β-blocker, nitroglycerin, and adenosine. Body mass index >35kg/m2. Complex congenital heart disease other than anomalous coronary origins alone. Ventricular septal defect.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lorenz Raeber, Prof. MD PhD
Phone
+41316322111
Email
lorenz.raeber@insel.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Hiroki Shinutani, MD
Phone
+41316322111
Email
hiroki.shibutani@extern.insel.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorenz Raeber, Prof. MD PhD
Organizational Affiliation
Inselspital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Géraud Souteyrand, Prof.
Email
gsouteyrand@chu-clermontferrand.fr
Facility Name
Institute Mutualiste Montsouris
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Amabile, Dr. med.
Email
nicolasamabile@yahoo.fr
Facility Name
Centre Cardiologique du Nord
City
Saint-Denis
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franck Digne, Dr. med
Email
f.digne@ccn.fr
Facility Name
Universitätsklinikum Giessen Justus-Liebig Universität
City
Gießen
State/Province
Hesse
ZIP/Postal Code
35392
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nef Holger, Professor
Phone
641 98556220
Ext
+49
Email
Holger.Nef@innere.med.uni-giessen.de
Facility Name
Friedrich Alexander Universität (FAU) , Medizinische Klinik 2 , Kardiologie und Angiologie
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephan Achenbach, Prof.
Email
Stephan.Achenbach@uk-erlangen.de
Facility Name
Ageo Central General Hospital
City
Ageo
ZIP/Postal Code
362-8588
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masataka Nakano, Dr. med
Facility Name
Gifu heart center
City
Gifu
ZIP/Postal Code
500-8384
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matsuo Hitoshi, Dr.
Phone
58-277-2277
Ext
+81
Email
matsuo@heart-center.or.jp
Facility Name
Department of Cardiovascular Medicine Shinshu University School of Medicine
City
Nagano
ZIP/Postal Code
390-8621
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasushi Ueki, Dr. med. PhD
Email
yasushi522@shinshu-u.ac.jp
Facility Name
Kansai Medical University,
City
Osaka
ZIP/Postal Code
573-1010
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenichi Fuji, Dr.med
Facility Name
Medical Corporation Ouyuukai Tokorozawa Heart Center
City
Saitama
ZIP/Postal Code
359-1142
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taniwaki Masanori, Dr.
Phone
4 2940 8611
Ext
+81
Email
grand_wagoneer_797@hotmail.com
Facility Name
Sapporo Higashi Tokushukai Hospital
City
Sapporo
ZIP/Postal Code
065-0033
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuki Katagiri, Dr. med
Email
ykatagiri.ggl@gmail.com
Facility Name
Inselspital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorenz Räber, Prof MD
Phone
+41 31 632 09 29
Email
lorenz.raeber@insel.ch
Facility Name
CHUV
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephane Fournier, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27810312
Citation
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Results Reference
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Results Reference
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Citation
Jasti V, Ivan E, Yalamanchili V, Wongpraparut N, Leesar MA. Correlations between fractional flow reserve and intravascular ultrasound in patients with an ambiguous left main coronary artery stenosis. Circulation. 2004 Nov 2;110(18):2831-6. doi: 10.1161/01.CIR.0000146338.62813.E7. Epub 2004 Oct 18.
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Comparison of Optical Coherence Tomography-derived Minimal Lumen Area, Invasive Fractional Flow Reserve and FFRCT

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