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| Name | Class |
|---|---|
| Guidant Corporation | INDUSTRY |
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Coronary Intervention (PCI) | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| In-stent and In-segment late lumen loss |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | ||
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Herman K Gold, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| 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.) |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D019060 | Minimally Invasive Surgical Procedures |