Andreas Gruentzig Center
A Randomized, Multicenter, Open-Label Study to Evaluate the Efficacy of Tirofiban Using a High-Dose Bolus Plus a Shortened Infusion Duration Versus Label-Dosing Eptifibatide in Patients Undergoing Percutaneous Coronary Intervention
Purpose: The purpose this study is to assess whether a tirofiban regimen of a high-dose bolus plus a shortened infusion duration compared to label-dosing eptifibatide in patients undergoing percutaneous coronary intervention (PCI) is associated with a non-inferior composite rate of death, PCI-related myocardial infarction, urgent target vessel revascularization or in-hospital major bleeding within 48 hours following PCI or hospital discharge, whichever comes first.
- Age >18 years of age
- Scheduled to undergo PCI with an approved device in one or more target lesions
- Written informed consent
Sponsor: St. Jude Medical
Purpose: To define and evaluate OCT stent guidance parameters through prospective data collection in PCI procedures of de novo lesions.
- Age ≥ 18 years.
- Patient provides signed written informed consent before any study-specific procedure.
- De novo coronary artery disease in target vessel.
- Single or multi vessel disease. For multi vessel disease up to two vessels and three lesions treated, with no more than two lesions per vessel. Vessel is defined as, left anterior descending, left circumflex, and right coronary arteries. Any branch within the vessel is considered part of the vessel.
- Elective or ad hoc PCI, stable angina, acute coronary syndrome (unstable angina and NSTEMI).
- Angiographically significant (>50% visual estimation) stenosis present in at least one native coronary artery.
- Mandatory use of FFR and OCT pre and post PCI. PCI strongly recommended in subjects with an FFR ≤ 0.80 in target vessel.