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To define and evaluate the impact of angiographic coregistered OCT on physicians decision-making through prospective data collection in PCI procedures.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Coronary Intervention | Procedure | OCT-guided Percutaneous Coronary Intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary study objective is the change in PCI strategy after pre-procedural ACR as compared to OCT imaging alone | 20 months |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac event (MACE)-rate (death, myocardial infarction, Re-angiography, Re-PCI and renal failure requiring dialysis), after recruitment. | 30 days, 6 months, and 12 months. | |
| Change in PCI strategy after pre-procedural OCT imaging in comparison to conventional angiography alone. |
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Inclusion Criteria:
Exclusion Criteria:
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Elective or ad hoc PCI, stable Angina, acute coronary syndrome
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| Name | Affiliation | Role |
|---|---|---|
| David M Leistner, PD | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin | Berlin | 12203 | Germany |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| 20 months |
| Longitudinal geographical miss (GM) with uncovered residual parts of "target lesion" at the proximal or distal reference segment of the stent. Detected by comparison between pre-PCI OCT with post-PCI OCT. | 20 months |
| Rate of side branch occlusions (%). | 20 months |
| Strategy changes based on post-procedural OCT and ACR Imaging. | 20 months |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D019060 | Minimally Invasive Surgical Procedures |