Femoropopliteal artery lesion area (Rutherford 1 category 4) in type 2 diabetes complicated by a chronic arteriosclerosis obliterans
Conditions
Interventions
Pioglitazone treatment groups: pioglitazone 15mg orally once daily after breakfast. Aiming HbA1C6.5% less than the oral hypoglycemic drug dosage may be adjusted. If you get side effects, the physici
s discretion, lose weight or stop.
Pioglitazone untreated group: standard care(SU drugs, Alpha-glucosidase inhibitor, Gurinido drugs, Biguanide drugs), the aim HbA1C6.5% less than the oral hypoglyce
s discretion, lose weight or stop.
Sponsors
Division of Cardiovascular Medicine , Department of Internal Medicine, Kobe University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with diabetes type 2 2. Femoropopliteal artery lesion area (Rutherford 1 - 4 categories) patients having chronic obstructive atherosclerosis. However, acute (7 days), subacute (less than one month) is to exclude patients with limb ischemia. 3. Normal proximal portion , an average diameter of the target vessel distal vessel diameter of 4-6mm blood vessels in the average visual Target. 4. Stenosis or occlusion in the superficial femoral artery angiography new , TASKII Category A or B or C corresponding to the lesion. From the deep femoral artery bifurcation lesions in the distal superficial femoral artery and more than 1cm, 3cm from the patella to target those that exist between more proximal. 5. Run-off arteries below the knee and one or more, flow limiting stenosis, if you can not. In addition, patients with lesions on both sides of a merger, the aorta - a target for patients with iliac artery disease complications. However, endovascular treatment of bilateral lesions in patients with 30 days to make the treatment of each limb at intervals of 45 days. 6. Lower extremity arterial (BK:Below knee), iliac artery (Iliac Artery) with simultaneous treatment possible. 7. A target for occlusion
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| After six months of treatment before and IVUS neointimal thickness by the amount of quantitative assessment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactToshiro Shinke
Department of Internal Medicine, Kobe University Graduate School of Medicine Division of Cardiovascular Medicine
Outcome results
None listed