|
Table 1: In-stent restenosis trials. |
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|
Trial |
Design |
Year |
n |
Scenario |
Material |
|
AGENT43 |
1:1, Open-Label, Core Lab, CEC |
2019 |
125 |
Restenosis in-stent BMS or DES |
PCB: 3 µg/mm2 iopromide, ATBC 2 µg/mm2 |
|
BIOLUX- RCT44 |
2:1, Open-Label, Core Lab, CEC |
2018 |
229 |
Restenosis in-stent BMS or DES |
SES, PCB 3 µg/mm2 BTHC |
|
DARE45 |
1:1, Open-Label, Core Lab, CEC |
2018 |
278 |
Restenosis in-stent BMS or DES |
EES, PCB 3 µg/mm2 iopromide |
|
ESSENTIAL46 |
Open-Label, Core Lab, CEC |
2019 |
30 |
Restenosis in-stent BMS or DES |
3 µg/mm2 paclitaxel organic ester |
|
ISAR- DESIRE47 |
1:1, Open-Label, Core Lab, CEC |
2013 |
340 |
Restenosis in-stent DES |
PES, PCB 3 µg/mm2 iopromide |
|
PACCCATH48 |
1:1, Open-Label, Core Lab, CEC |
2006 |
52 |
Restenosis in-stent BMS and DES |
PCB 3 µg/mm2 iopromide and POBA |
|
PEPCAD II49 |
1:1, Open-Label, Core Lab, CEC |
2009 |
131 |
Restenosis in-stent BMS |
PES, PCB 3 µg/mm2 iopromide |
|
PEPCAD CHINA50 |
1:1, Open-Label, Core Lab, CEC |
2014 |
221 |
Restenosis in-stent DES |
PES, PCB 3 µg/mm2 iopromide |
|
RESTORE51 |
1:1, Open-Label, Core Lab, CEC |
2018 |
172 |
Restenosis in-stent DES |
EES, PCB 3 µg/mm2 iopromide |
|
RIBS IV52 |
1:1, Open-Label, Core Lab, CEC |
2015 |
309 |
Restenosis in-stent DES |
EES, PCB 3 µg/mm2 iopromide |
|
RIBS V53 |
1:1, Open-Label, Core Lab, CEC |
2014 |
189 |
Restenosis in-stent BMS |
EES, PCB 3 µg/mm2 iopromide |
|
SEDUCE54 |
1:1, Open-Label, Core Lab, CEC |
2014 |
50 |
Restenosis in-stent BMS |
EES, PCB 3 µg/mm2 iopromide |
|
TIS55 |
1:1, Open-Label, Core Lab, CEC |
2016 |
136 |
Restenosis in-stent BMS |
EES, PCB 3 µg/mm2 iopromide |
|
CEC = clinical events committee. BTHC = butyryl-tri-hexyl-citrate. ATBC = acetyl tributyl citrate. BMS = bare metal stent. DES = drug-eluting stent. PCB = paclitaxel-coated balloon. SES = sirolimus-eluting stent. EES = everolimus-eluting stent. |
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