Table 1.

Study Characteristics

					Primary Analysis (Original Data)				Updated Data
Study	NCT Identifier	Enrollment Time Frame	N Subjects	Allocation Ratio (Treatment: Control)	Median Years Follow-up	Total Patient-Years Follow-up	N Deaths	Unknown Status	Median Years Follow-up	Total Patient-Years Follow-up	N Deaths	Unknown Status
ILLUMENATE Pivotal	NCT01858428	2013–2015	300	2:1	3.1	993.9	36	34	3.1	993.9	36	34
ILLUMENATE EU RCT	NCT01858363	2012–2015	294	3:1	4.0	1045.7	39	52	4.0	1045.7	39	52
IN.PACT SFA I/II	NCT01175850 NCT01566461	2010–2013	331	2:1	4.9	1395.1	39	60	4.9	1608.1	53	9
IN.PACT SFA Japan	NCT01947478	2013–2015	100	2:1	3.0	282.5	6	8	3.0	282.5	6	8
Levant I	NCT00930813	2009–2009	101	1:1	2.0	181.2	9	17	2.0	181.2	9	17
Levant II	NCT01412541	2011–2012	476	2:1	4.9	1918.4	72	78	4.9	2186.1	90	20
Lutonix Japan	NCT01816412	2013–2014	109	2:1	2.0	203.1	5	5	2.0	203.1	5	5
Zilver PTX	NCT00120406	2005–2008	474	1:1	4.9	1817.7	65	174	6.2	3251.9	148	31
All Studies		2005–2015	2185		4.0	7837.7	271	428	4.8	9752.5	386	176

The studies were conducted in the following countries: ILLUMENATE Pivotal: United States, Austria; ILLUMENATE EU RCT : Germany; IN.PACT SFA: United States, Germany; IN.PACT Japan: Japan; Levant I: Belgium, Germany; Levant II: United States, Austria, Belgium, Germany; Lutonix Japan: Japan; Zilver PTX: United States, Germany, Japan