Coronary Artery Disease
Conditions
Brief summary
To define and evaluate the impact of angiographic coregistered OCT on physicians decision-making through prospective data collection in PCI procedures.
Interventions
PROCEDUREPercutaneous Coronary Intervention
OCT-guided Percutaneous Coronary Intervention.
Sponsors
Charite University, Berlin, Germany
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Germany
Outcome results
None listed