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

Charité University Medicine Berlin

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Procedure: Percutaneous Coronary Intervention

Study type: Observational

Funder types: Other

Identifiers

NCT02919943

OPTICO-Integration I

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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