Patient with Peripheral Artery Disease
Conditions
Interventions
1.Drug eluting stent group: Treatment with ticlopidine hydrochloride 200 mg/day BID (morning and evening) or clopidgrel 75mg/day and aspirin at 100 mg/day will be started 3 to 7 days prior to EVT and
Sponsors
Shinshu university hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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 femoropopliteal artery area* (Rutherford classification 2-4) (see Appendix 1) *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 2 years after surgery (Patients who can undergo follow-up angiography 2 years after surgery) Lesion criteria 1. Angiographically-confirmed new significant superficial femoral artery stenosis or occlusive lesions. The inferior and superior poles of the superficial femoral artery are defined as the overlap with the bone in the adductor canal in the upper part of the femur, and the origin of the bifurcation, respectively. 2. At least 1 arterial runoff below the knee; stenosis lesions not limiting flow may be included.
Exclusion criteria
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.Patients with congestive cardiac failure (NYHA III or IV or EF<30%) 3.Patients implanted a drug-eluting stent (DES) within 3months 4.patients with a history of serious adverse reaction such as leukopenia, hepatic dysfunction, or renal dysfunction, or hypersensitivity to any component of the study drug. 5.Pregnant or potentially pregnant women 6.Patients with acute lower limb ischemia 7.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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major adverse Lower limb events (major or minor amputation, progression to bypass surgery, repeated revascularization, stent thrombosis,death related Limb events,bleeding) | — |
Countries
Japan
Contacts
Public ContactTakashi Miura
Shinshu university hospital cardiology
Outcome results
None listed