Observational Study of Angiographic Coregistered Optical Coherence Tomography in Patients Undergoing PCI

Study Overview
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Brief Summary
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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.

Official Title
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Impact of Angiographic Coregistered Optical Coherence Tomography-diagnostics on Physicians Decision-making During Percutaneous Coronary Intervention in Patients With Advanced Coronary Artery Disease - the OPTICO-Integration-Trial

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Percutaneous Coronary Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years. Patient provides signed written informed consent before any study-specific procedure. Patients suffer from coronary artery disease (CAD) including at least one angiographically significant (>70% visual estimation) stenosis present in a native coronary artery with planned PCI. Exclusion Criteria: Subjects with emergent PCI or in cardiogenic shock. Subjects with target left main (LM) lesion, with restenosis or stent thrombosis in the target vessel or with aorto-ostial lesion location within 3 mm of the aorta junction (both right and left). Extreme angulation (> 90°) or excessive tortuosity (> two 45° angles) proximal to or within the target lesion. Known renal insufficiency (examples being but not limited to estimated glomerular Filtration rate (eGFR) < 50 ml/kg/m2, serum creatinine ≥ 2.5 mg/dL or on dialysis). Any other medical condition that in the opinion of the investigator will interfere with patients safety or study results. Currently participating in another clinical study that interferes with study results. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Any condition that precludes the subject from undergoing PCI, for example subjects with heparin induced thrombocytopenia, or contrast allergy

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: Percutaneous Coronary Intervention|OCT-guided Percutaneous Coronary Intervention.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. |  | 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 |