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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparison of OCT scans | Procedure | |||
| Comparison of Intra Vascular Optical Coherence Tomography Systems for Assessment of Coronary Tissue, Stents and Scaffolds - DOCTOR Compare | Procedure |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive patients undergoing percutaneous coronary intervention (PCI) at Department of Cardiology, Aarhus University Hospital Skejby, will be invited to participate in the study. 12 patients will be included; 4 with acute ST-elevation myocardial infarct (STEMI) and 8 stable or stabilized patients.
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| Name | Affiliation | Role |
|---|---|---|
| Niels R Holm, MD | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus N, Denmark | 8200 | Denmark | |||
| Rigshospitalet |
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| Copenhagen |
| 2100 |
| Denmark |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D009203 | Myocardial Infarction |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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| ID | Term |
|---|---|
| D015607 | Stents |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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