Table 1.

Clinical Outcomes for adverse event detection (Primary Endpoints)

	Type of Device	Clinical Outcomes of Interest
1	Drug eluting stent	In-hospital death
		Peri-procedural myocardial infarction (in-hospital)
		Major adverse cardiac events: Composite of in- hospital death, peri-procedural myocardial infarction, stroke or unplanned coronary revascularization.
2	Vascular closure device	Major vascular complications (including retroperitoneal hemorrhage, limb ischemia and any surgical/interventional repair)
		Minor vascular complications (including groin bleeding, hematoma, pseudo aneurysm and arteriovenous fistula)
		All vascular complications (in-hospital)
3	Embolic Protection Device	In-hospital death
		Peri-procedural myocardial infarction (in-hospital)
		Major adverse cardiac events: Composite of in- hospital death, peri-procedural myocardial infarction, stroke or unplanned coronary revascularization.
	Non Device related Continuous Outcomes of Interest
1	Quantitative change in serum creatinine (mg/dl) in high-risk patient subgroups including diabetics, patients with pre-existing renal dysfunction (estimated glomerular filtration rate < 50ml/min), procedures with contrast volume >300cc, and patients undergoing multivessel procedures in which >3 stents are deployed.
2	Quantitative change in post-procedure creatinine kinase MB fraction (CK-MB, IU/L) in patients at increased risk for peri-procedural myocardial infarction. Patient subsets will include those with stenting at a side branch, treatment of unstable angina, treatment of saphenous vein grafts, and use of adjunctive atherectomy or thrombectomy devices.