We hypothesize that the combination of the thin-strut MULTI-LINK (i.e. VISION(tm) and/or MINI-VISION(tm)) stent and pharmacologic therapy with the oral PPAR-gamma agonist rosiglitazone will significantly reduce restenosis after intracoronary stenting in type 2 diabetic patients. This approach would present a more effective and economical alternative to the use of drug-eluting stents to reduce stent restenosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
120
Massachusetts General Hospital
Boston, Massachusetts, United States
In-stent and In-segment late lumen loss
In-stent mean percent diameter stenosis (%DS) and binary restenosis as measured by QCA at post-procedure and at 8 months
TLR and TVR at 30 days, and 8 months post procedure
TVF defined as cardiac death, MI, or TVR at 30 days, 8 months and l year post-procedure
Composite of Major Adverse Cardiac Events (MACE)
The association of metabolic factors and inflammatory indices including glycemia (HgbA1C), diabetic therapy other than TZDs, HSCRP, coagulation (PAI-1, FIB) and inflammatory marker levels (ADI, MPO, &MMP-9) with the risk for restenosis
Target HgbA1C≤7 for all patients enrolled
Coronary artery stenosis progression in at least one non-stented lesion
Coronary artery stenosis regression in at least one non-stented lesion
Culprit (i.e. stented artery) artery stenosis progression/regression by intravascular ultrasound (IVUS)
(There are 3 more secondary endpoints not listed here.)
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