DOCTOR Compare - A Study in the DOCTOR Series (Does Optical Coherence Tomography Optimize Revascularization?

Study Overview
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Brief Summary
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The purpose of this study is to compare optical coherence tomography (OCT) scans performed in the same coronary artery with two different OCT systems (Lunawave and OPTIS) before and after implantation of stents or bioresorbable scaffolds.

Detailed Description
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Standard treatment of persons with narrowings of the heart's coronary artery is balloon treatment with implantation of stents (Percutaneous coronary intervention (PCI )). To evaluate disease in coronary arteries prior to, and during PCI , X-ray fluoroscopy with contrast is used. X-ray fluoroscopy produces little information of any disease changes in the vessel wall and implanted stents and especially polylactid acid (PLA) type bioresorbable scaffolds are visualized poorly . Optical coherence tomography (OCT) is a light-based, high resolution, imaging modality for intra coronary assessment of tissue and implants. Currently two CE-marked OCT systems are used in clinical practice in (Illumien OPTIS, St. Jude Medical , Minnesota, USA and Lunawave, Terumo , Tokyo, Japan). It is a common assumption that the scanning images for the two systems are similar and are interpreted the same way. The aim of the study is to assess if tissue, stents and PLA type scaffolds are presented with same characteristics by the two systems. Same segment scans by the two systems will be systematically compared and reported. Differences in scans by the two systems may have implications for the interpretation and thus may affect clinical decisions.

Official Title
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Comparison of Intra Vascular Optical Coherence Tomography Systems for Assessment of Coronary Tissue, Metallic Stents and Bioresorbable Vascular Scaffolds - DOCTOR Compare

Conditions
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Coronary Disease, Myocardial Infarction, Atherosclerosis

Intervention / Treatment
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* Procedure: Comparison of OCT scans
* Procedure: Comparison of Intra Vascular Optical Coherence Tomography Systems for Assessment of Coronary Tissue, Stents and Scaffolds - DOCTOR Compare


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indication for intervention with PCI on the right or left coronary artery Age >18 years Must be able to give written informed consent Exclusion Criteria: Expected life span of less than one year Pregnancy or possible pregnancy Cardiogenic shock Especially tortuous vessels Renal impairment (creatinine> 100 micromoles / L)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Comparison of OCT scans|nan|
|Procedure: Comparison of Intra Vascular Optical Coherence Tomography Systems for Assessment of Coronary Tissue, Stents and Scaffolds - DOCTOR Compare|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of quantitative and semi-quantitative tissue analysis obtained with OCT images |  | Baseline | 
| Characteristics of thrombic mass (average thickness of signal-rich area, shade degree) |  | Baseline | 
| Characteristics of fibrous tissue (maximum scan penetrance) |  | Baseline | 
| Characteristics of lipid plaque (signal intensities under the fibrous cap) |  | Baseline | 
| Characteristics of calcium plaque (matched calcium plaques that can be quantified for sizes) |  | Baseline | 
| Characteristics of vessel dissection (exploratory) |  | Baseline | 
| Characteristics of the fibrous cap (minimum thickness) |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of stent struts | Stent evaluation obtained by Lunawawe recordings versus OPTIS recordings (including areas with thrombus, plaque, bare metal stent, bioresorbable stents, 3D reconstruction of stents (qualitative and quantitative assessment of stent visualization degree) | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Optical coherence tomography, Stent, Bioresorbable stents, Myocardial infarction, Atherosclerosis, PCI, OCT