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. 2006 Apr 1;6(12):1–97.
Study Method of
Randomization/
Concealment
Spectrum Blinding – patient & operator Interpretation of CAG, IVUS & clinical outcomes Documentary IVUS in Angio group Statistical Power ITT
Gaster 2001, 2003 (28) Drawing lots from sealed opaque envelops

Concealed
Males with stable angina scheduled for PCI No CAG – blinded IVUS- unblinded
Clinical assessment-blinded
Yes No stated Yes
SIPs 2000 (25) Day-to-day block schedule each morning

Concealment not stated
All patients undergoing PTCA or
primary stenting in vessel 2.2–4.6 mm in diameter
No Not stated Not stated Powered to detect 0.104mm chronic difference in MLD Yes
OPTICUS 2001 (21) By fax from central office before start of procedure

Concealed
Patients with angina or documented ischemia, no long lesions or small vessel No Angiographic & IVUS measured blind Not stated Powered to detect 10% absolute ↓ in binary restenosis rate Yes
RESIST 1998, (22) 2000 (23) After satisfactory
QCA stent deployment
Method of randomization unknown

Concealment unknown
Symptomatic CAD>70% stenosis in 1 or more coronary undergoing PTCA+ stenting No Angio analysis blinded to IVUS results Yes 40% power to detect a 15% absolute ↓ in restenosis rate Yes
TULIP 2003 (26) Just before the procedure.
Method not stated.

Concealment unknown
Consecutive patients for elective PCI, Only long lesions ≥ 20 mm, no narrow vessels. No Angio analysis blinded to IVUS assignment Not stated Powered to detect >0.25mm difference in MLD in 6 months Yes
AVID 1997 (31) 2000 (27)(Abstract) Method not stated

Concealment unknown
Undergoing elective stenting in vessel >2.5mm, & @ low risk for complications No Not stated Yes Not reported Not reported

Angio or QCA quantitative coronary angiography; IVUS intravascular ultrasound; CAD coronary artery disease; MLD minimal lumen diameter; ITT intention-to-treat analysis