Coronary drug-eluting stent development: issues in trial design.
Muni
Neal I
NI
Center for Devices and Radiological Health, U.S. Food and Drug Administration, Rockville, Md 20850, USA. neal.muni@fda.hhs.gov
Califf
Robert M
RM
Foy
Jonette R
JR
Boam
Ashley B
AB
Zuckerman
Bram D
BD
Kuntz
Richard E
RE
D000818:Animals; D002986:Clinical Trials as Topic / Q000379:methods*; D023903:Coronary Restenosis / Q000175:diagnosis / Q000209:etiology; D023921:Coronary Stenosis / Q000628:therapy; D016503:Drug Delivery Systems / Q000379:methods*; D004867:Equipment Design; D006801:Humans; D020714:Maximum Tolerated Dose; D023421:Models, Animal; D010599:Pharmacokinetics; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D012008:Recurrence; D012107:Research Design; D015607:Stents / Q000009:adverse effects