coronary artery disease
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - patients who are included in PAPPA-pilot (acute myocardial infarction presented for primary PCI within 12h after onset symptoms and treated with a paclitaxel-eluting ballon and additionally stentplacement if indicated) - patients understand the risk of coronary angiography and give written informed consent.
Exclusion criteria
Exclusion criteria: - revascularization of target lesion by PCI or coronary artery bypass grafting. - participation in another clinical study, interfering with this protocol. - renal impairment at risk for contrast nephropathy, defined as creatinin > 130 mmol/L (or >1.47 mg/dl) - the inability to provide written informed consent. - initial angiography not suitable for quantitative coronary angiography (QCA).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary angiographic endpoint to be evaluated is the late in-segment luminal loss as determined by laboratory measurement of the difference between the minimal lumen diameter (MLD) at follow-up catheterization and post-initial procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include binary restenosis defined as >=50% diameter stenosis at follow-up, located within the target segment, respectively, and other angiographic results e.g. late occlusion. | — |
Countries
Netherlands