title: Clinical trial design.
abstract: Clinical trials of radiation therapy provide the first opportunity to examine a device therapy in a truly blinded manner. Observational studies suggest that moderate-sized clinical trials can adequately test the ability of the method to reduce restenosis. The mechanism by which such reduction is achieved should be studied by angiographic and intravascular ultrasound methods although clinical outcomes will be uniquely valuable because of the blinding.
authors.affiliation: Andreas Gruentzig Cardiovascular Center, Emory University Hospital, Atlanta, GA 30322, USA.
authors.forename: S B
authors.initials: SB
authors.lastname: King
mesh_terms: D001918:Brachytherapy / Q000295:instrumentation / Q000379:methods; D002986:Clinical Trials as Topic; D003327:Coronary Disease / Q000517:prevention & control* / Q000532:radiotherapy / Q000628:therapy; D003331:Coronary Vessels / Q000528:radiation effects*; D004867:Equipment Design; D005240:Feasibility Studies; D006801:Humans; D015337:Multicenter Studies as Topic; D010865:Pilot Projects; D011879:Radiotherapy Dosage; D016032:Randomized Controlled Trials as Topic; D012008:Recurrence; D012107:Research Design