Coronary Artery Lesions. Ischemia (lack of O2) in the heart muscle due to atherosclerosis/cholesterol
Conditions
Interventions
Sponsors
Johnson & Johnson
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subject has atherosclerotic coronary artery disease with an indication for stent implantation; 2. Target lesion(s) with a diameter stenosis of minimally 50% (visual estimate) OR a functional study documenting the hemodynamic relevance of the target lesion(s); 3. All target lesion(s) require treatment with stents having diameters from 2.5mm to 3.5mm (visual estimate); 4. Subject is >=18 years of age; 5. Subject must sign Ethics Committee approved informed consent prior to undergoing any study specific procedure; 6. Subject must be willing and able to comply with specified follow-up schedule.
Exclusion criteria
Exclusion criteria: 1. Planned medical procedures or concomitant disease requiring modification of DAPT regimen within 6 months of enrollment into this study; 2. Women of childbearing potential without negative pregnancy test within 7 days before enrollment OR women who do not agree to remain on birth control until angiographic follow-up at 13 months if applicable OR lactating women. For women of childbearing potential, requiring an acute, non-elective procedure, a verbal confirmation of non pregnancy and birth control is sufficient; 3. Currently participating in an investigational study that has not completed the primary endpoint or that clinically interferes with the study endpoints.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Twelve month composite clinical endpoint of all death, all MI and all revascularizations. | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured as defined in the protocol: - Composite endpoint of all death, all MI and all revascularizations and its individual components. - Stent thrombosis defined as definite, probable, possible and composite of definite and probable at early, late and very late time points (using ARC definition) - Bleeding complication - Stroke - Device, Procedural and Lesion Success | — |
Countries
Netherlands
Outcome results
None listed