Symptomatic arteriosclerosis obliterans
Conditions
Interventions
After EVT, antiplatelet therapy is followed up with DAPT for 3 months after surgery / aspirin monotherapy group for 12 months and clopidogrel monotherapy group for 12 months.
Sponsors
Soga Yoshimitsu
General Incorporated Association Peripheral Vascular Regeneration Research Group LIBERAL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients with symptomatic superficial femoral artery(SFA)or proximal popliteal artery(PA)target lesions requiring peripheral revascularization(whether new or restenotic) 2. Patients scheduled for endovascular treatment(EVT)using a paclitaxel-eluting device(drug-eluting stent (DES)or drug-coated balloon(DCB))for the lesions of(1)above 3.Patients with a Rutherford classification of 2-4 4.Patients who can continue DAPT for 3 months
Exclusion criteria
Exclusion criteria: 1.Patients enrolled in other intervention trials 2.Patients with known hypersensitivity to paclitaxel 3.Patients contraindicated by the use of aspirin,thienopyridine drugs 4.Diseases including hemorrhagic diathesis (other than thrombocytopenia,von Willebrand disease,hemophilia,etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary patency rate of target lesions at 12 months after procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Death, myocardial infarction, stroke 2.MAE(death, myocardial infarction, stroke, amputation of the lower extremities, ALI, surgical bypass, any re-intervention) 3.MALE(ALI, surgical bypass, any re-intervention)avoidance rate 4.CD-TLR,TLR,TVR 5.Any reintervention 6.ALI 7.surgical bypass 8.Hemorrhagic event bleeding that falls under 3 or 5 of the BARC criterion (Intracranial bleeding,Gastrointestinal bleeding) 9.Changes in resting ABI 10.Rutherford Classification Trends | — |
Contacts
Public ContactKazuhiro Minagawa
CV quest Co., Ltd.
Outcome results
None listed