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This prospective, multicenter, non-randomized, single arm, objective performance goal (OPG) study is designed to evaluate clinical outcomes after complete revascularization by PCI and imaging guidance (OCT) in patients with multivessel coronary artery disease including left anterior descending (LAD) presenting with stable angina, or documented silent ischemia, or non-ST segment elevation acute coronary syndrome (NSTE-ACS).
The PRESENT is an investigator-initiated, prospective, multicenter, non-randomized, single arm, OPG study. The objective performance goal is based on past results of CABG namely a rate of 7% MACCE at 1-year follow-up. All patients with multivessel disease without chronic total occlusion (CTO) and accepted for PCI are eligible for inclusion
Primary endpoint The primary clinical endpoint of this study is a composite of death from any cause, stroke, myocardial infarction, or unplanned ischemia driven repeat revascularization at 1-year post index procedure.
Secondary endpoint
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Percutaneous Coronary Intervention | Other | Interventional comparitor, compared to an optimal performance goal of 7% MACCE resulted from past CABG results |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCI with OCT guidance | Device | Procedure will be optimize using pre-and post-stent OCT imaging, to improve the accuracy of stent placement and reduce geographic miss, but also to prevent malapposition of the stent and to discover dissections. |
| Measure | Description | Time Frame |
|---|---|---|
| MACCE- 1 year | The primary clinical endpoint of this study is a composite of death from any cause, stroke, myocardial infarction, or unplanned ischemia driven repeat revascularization at 1-year post index procedure. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| MACCE | Composite of death from any cause, stroke, myocardial infarction, or repeat revascularization | 30 days, 2, and 5 years post intervention |
| All-cause mortality | All-cause mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roberto Diletti, MD PhD | Contact | +31 (0)10 70 352 60 | r.diletti@erasmusmc.nl | |
| Hala Kakar, MD | Contact | h.kakar.1@erasmusmc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Roberto Diletti, MD PhD | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus Medical Center | Recruiting | Rotterdam | South Holland | 3015 GD | Netherlands |
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| 30 days, 1, 2, and 5 years |
| Myocardial Infarction | Myocardial Infarction | 30 days, 1, 2, and 5 years |
| Any revascularization | Any revascularization | 30 days, 1, 2, and 5 years |
| Stroke | Stroke | 30 days, 1, 2, and 5 years |
| Major bleeding | Major bleeding according to the ARC criteria | 30 days and 12 months |
| Renal replacement therapy | Need for renal replacement therapy | 30 days |
| ID | Term |
|---|---|
| D000072658 | Non-ST Elevated Myocardial Infarction |
| D000789 | Angina, Unstable |
| D060050 | Angina, Stable |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| 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 |
| D000787 | Angina Pectoris |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive 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 |
| D019060 | Minimally Invasive Surgical Procedures |
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