Peripheral arterial disease
Conditions
Interventions
Aspirin group (aspirin 100mg/day)
Cilostazol group (cilostazol 100-200mg/day BID)
Cilostazol/Clopidogrel group (cilostazol 100-200mg/day BID, clopidogrel 75mg/day) In every group, oral treatment
Sponsors
Saiseikai yokohama city eastern hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient criteria Patients who meet all of the following criteria will be included in the study: 1. Chronic arteriosclerosis obliterans afflicting the SFA area* (Rutherford classification 2-4) *Except for patients with acute (within 1 week after onset)/subacute (2 weeks to 1 month after onset) lower limb ischemia 2. Age: 20 years or older at the time of consent 3. Gender: Male or female 4. Patients who can be monitored for at least 24 months after surgery Lesion criteria 1. New significant superficial femoral artery stenosis or occlusive lesions. 2. At least 1 arterial runoff below the knee; stenosis lesions not limiting flow may be included. In addition, patients with bilateral lesions or aorta-iliac artery lesions may be included. 3. Occlusive lesions may be included.
Exclusion criteria
Exclusion criteria: Patient criteria Patients who meet any of the following criteria should be excluded from the study: 1.Patients with or at risk of hemorrhagic complications or patients with bleeding* tendency *Bleeding such as hemophilia, capillary fragility, intracranial hemorrhage, gastrointestinal hemorrhage, urinary tract hemorrhage, hemoptysis, or vitreous hemorrhage may be aggravated. 2.Pregnant or potentially pregnant women 3.Patients with acute lower limb ischemia 4. Patients who are not eligible for the study in the opinion of the attending physician. Lesion criteria Lesions that meet any of the following criteria should be excluded from the study: 1.Remnant inflow (aorta-iliac artery lesion) 2.Severe calcification (lesions not expected to be appropriately expanded) 3.No arterial runoff below the knee
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Angiographic restenosis rate (12 months)(-1month+1month) | — |
Secondary
| Measure | Time frame |
|---|---|
| Patency rate, ABPI, Cardiovascular events (death, MI, stroke), Lower limb vascular events, all cause mortality | — |
Countries
Japan
Contacts
Public ContactYasunari Sakamoto
Saiseikai yokohama city eastern hospital cardiology
Outcome results
None listed