Subjects undergoing PCI for: -Angina (stable or unstable) -Silent ischemia (at least one of the following must be present: a visually estimated target lesion diameter stenosis of ?70%, a positive non-invasive stress test, or FFR ?0.80) -NSTEMI -Recent STEMI (>24 hours from initial presentation and stable)
Conditions
Interventions
Intervention type:DEVICE,PROCEDURE
Name of intervention:Randarmization
Dose form / Japanese Medical Device Nomenclature:DEVICE
Optical Coherence Tomography (OCT)
Route of administration / Site of app
Sponsors
St. Jude Medical
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: General Inclusion Criteria: 1) Age greater than or equal to 18 years 2) Patient with an indication for PCI including: - Angina (stable or unstable), - Silent ischemia (a visually estimated target lesion diameter stenosis of greater than or equal to 70%, a positive non-invasive stress test, or FFR less than or equal to 0.80 must be present), - NSTEMI, or - Recent STEMI (>24 hours from initial presentation and stable). 3) Patients will undergo cardiac catheterization and possible or definite PCI with intent to stent using any non-investigational metallic drug-eluting stent (DES) 4) Signed written informed consent Angiographic inclusion criteria: 1) The target lesion must be located in a native coronary artery with visually estimated reference vessel diameter of greater than or equal to 2.25 mm to less than or equal to 3.50 mm. 2) Lesion length <40mm Note: Overlapping stents are allowed
Exclusion criteria
Exclusion criteria: General Exclusion Criteria: 1) Estimated creatinine clearance 1/3 of lungs) or radiographic interstitial or alveolar pulmonary edema 11) Subject is intubated. 12) Known LVEF 50%, or any additional target vessel stenosis which requires PCI either during or within 12 months after the study procedure Note: Patients may have non-study lesions in a non-target vessel that require PCI. These lesions must be treated prior to randomization, with the procedure being successful and uncomplicated. Alternatively non-study lesions in a non-target vessel may be treated >24 hours prior to or >48 hours after the study procedure. Successful and uncomplicated procedure is defined as 30 minutes), no peri-procedural MI as measured by CKMB >5x ULN or troponin >35x ULN. 2) Left main diameter stenosis ?30% or left main PCI planned. 3) Study target lesion in a bypass graft 4) Ostial RCA study target lesion 5) Chronic total occlusion (TIMI flow 0/1) study target lesion 6) Bifurcation study lesion with a planned dual stent strategy 7) In-stent restenosis study target lesion 8) Any study lesion characteristic resulting in the expected inability to deliver the IVUS or OCT catheter to the lesion pre and post PCI (e.g. moderate or severe vessel calcification or tortuosity)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Efficacy Endpoint (powered). Post-PCI MSA assessed by OCT in each randomized arm, measured at the independent OCT core laboratory blinded to imaging modality assignment. Testing will be done in a hierarchal manner as follows: 1. Non-inferiority of OCT guided stenting to IVUS guided stenting 2. Superiority of OCT guided stenting to Angiography guided stenting 3. Superiority of OCT guided stenting to IVUS guided stenting Primary Safety Endpoint (non-powered). Procedural MACE defined as procedural complications (angiographic dissection, perforation, thrombus, and acute closure) requiring active interventions (prolonged balloon inflations, additional stent implantations, or pericardiocentesis). | — |
Countries
Japan, United States
Contacts
Public ContactYuri Masui
St. Jude Medical
Outcome results
None listed