Coronary Artery Disease - Disease of the heart vessels
Conditions
Interventions
None listed
Sponsors
St. Jude Medical
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: General Inclusion Criteria: 1) Age >= 18 years. 2) Patient with an indication for PCI 3) Patients will undergo cardiac catheterization and possible or definite PCI with intent to stent using any non-investigational metallic drug-eluting stent (DES);Angiographic Inclusion Criteria: 1) The target lesion must be located in a native coronary artery with visually estimated reference vessel diameter of >=2.25 mm to
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
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 vs. IVUS guided stenting 2. Superiority of OCT guided stenting vs. Angiography guided stenting 3. Superiority of OCT guided stenting vs. 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 implantation, or pericardiocentesis). | — |
Secondary
| Measure | Time frame |
|---|---|
| Imaging measures by OCT in each study arm 1) Acute procedural success 2) Post-PCI stent expansion (%) 3) Mean stent expansion (%) 4) Intra-stent plaque protrusion and thrombus 5) Untreated reference segment disease 6) Edge dissections 7) Stent Malapposition 8) Border detection (OCT arm only) 9) Altered clinical decision making on the basis of the post-stent imaging run 10) Intra-stent Lumen Area (Intra-stent Flow Area) 11) Effective Lumen Area (Total Flow Area) 12) IVUS vs. OCT detected: A) Malapposition (Major, Minimal, All) (%) B) Dissection (Major, Minor, All) (%) C) Protrusion (Major, Minor, All) (%) Non OCT Secondary Endpoints Angiographic Endpoints (QCA) 1) Minimal lumen diameter 2) Percent diameter stenosis 3) Acute lumen gain post-intervention 4) Maximum stent size/reference vessel diameter ratio 5) Angiographic Dissection >= NHLBI type B Procedural Endpoints (site reported): 1) Total Stent Length 2) Total number of stents 3) Maximal Stent Size 4) Post dilatation inflations (yes/no) 5) Maximum inflation pressure (atm.) 6) Additional interventions on the basis of the post stent imaging run: A) Use of larger balloon B) Use of higher inflation pressures C) Use of additional inflations D) Use of additional stent(s) E) Thrombus aspiration F) Other interventions Additional Procedural and Clinical Endpoints 1) Angiography defined procedural success rate 2) Device success rate (site reported) 3) Target Lesion Failure at 1 year defined as cardiovascular death, target vessel myocardial infarction, or ischemia driven target-lesion revascularization. 4) Peri-procedural myocardial infarction. | — |
Countries
Netherlands
Outcome results
None listed