KOBE Study of Pioglitazone Effective in Preventing Restenosis after Endovascular Therapy
- Conditions
- Femoropopliteal artery lesion area (Rutherford 1 category 4) in type 2 diabetes complicated by a chronic arteriosclerosis obliterans
- Registration Number
- JPRN-UMIN000004474
- Lead Sponsor
- Division of Cardiovascular Medicine , Department of Internal Medicine, Kobe University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 50
Not provided
1. Patients with Congestive Heart Failure 2. Creatinine or 2mg/dL 3. Patients on hemodialysis 4. Leukopenia drug ingredients for research hepatic dysfunction, severe side effects such as renal dysfunction, Patients with a history of hypersensitivity 5. Patients are pregnant or potentially pregnant women 6. Subacute patients with acute limb ischemia 7. Insulin-treated patients (Eg, insulin administration was started during the study will continue to study) 8. Patients with a history of adverse reactions to thiazolidinediones 9. Patients with severe liver dysfunction in renal function 10. The patient will be excluded from the safety of thiazolidinediones in terms of 11. In addition, at the discretion of the attending physician considered patient inappropriate for study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method After six months of treatment before and IVUS neointimal thickness by the amount of quantitative assessment.
- Secondary Outcome Measures
Name Time Method 1. Patency rate 2. Ankle Brachial Pressure Index (ABI) 3. Rutherford classification (1-4) Change in 4. All-cause mortality and cardiovascular events(TIA, including ischemic stroke, hemorrhagic stroke, myocardial infarction and other vascular accident) 5. Lower limb vascular event Anputeshon (minor or major), move to bypass surgery, revascularization, Stent thrombosis 6. Stent breakage rate 7. Angiographic restenosis 8. Angiographic Late Loss 9. Safety: edema, hypoglycemia, and others