This trial is active, not recruiting.

Condition coronary artery disease
Treatment percutaneous coronary intervention
Sponsor Charite University, Berlin, Germany
Start date April 2016
End date September 2016
Trial size 50 participants
Trial identifier NCT02919943, OPTICO-Integration I


To define and evaluate the impact of angiographic coregistered OCT on physicians decision-making through prospective data collection in PCI procedures.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Rate of Changes in PCI-Strategy based on OCT vs. Angiographic coregistered OCT.
time frame: 20 months

Secondary Outcomes

Amount of administered contrast media (ml).
time frame: 20 months
Δ glomerular filtration rate (GFR) after to before coronary angiography.
time frame: 20 months
Dose-area product (cGy*cm2).
time frame: 20 months
Major adverse cardiac event (MACE)-rate (death, myocardial infarction, Re-angiography, Re-PCI and renal failure requiring dialysis), after recruitment within 30 days, 6 months, and 12 months.
time frame: 12 months
Rate of change in treatment planning and performance based on OCT findings, analyzed for changes pre-PCI only, post-PCI only, pre-PCI and post-PCI, or no change (neither pre- or post- PCI).
time frame: 20 months
Ratio: Stent-length (mm) /lesion length (mm).
time frame: 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.
time frame: 20 months
Rate of side branch occlusions (%).
time frame: 20 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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"
Principal investigator David M Leistner, PD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Charite University, Berlin, Germany.