Single versus dual antiplatelet therapy for feMOrOpopliTeal lesion treated witH paclItaxEl-eluting device.
Phase 4
Recruiting
- Conditions
- Symptomatic arteriosclerosis obliterans
- Registration Number
- JPRN-jRCTs031220617
- Lead Sponsor
- Soga Yoshimitsu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 400
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
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.)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary patency rate of target lesions at 12 months after procedure
- Secondary Outcome Measures
Name Time Method 1.Death, myocardial infarction, stroke<br>2.MAE(death, myocardial infarction, stroke, amputation of the lower extremities, ALI, surgical bypass, <br> any re-intervention)<br>3.MALE(ALI, surgical bypass, any re-intervention)avoidance rate<br>4.CD-TLR,TLR,TVR<br>5.Any reintervention<br>6.ALI<br>7.surgical bypass<br>8.Hemorrhagic event bleeding that falls under 3 or 5 of the BARC criterion<br> (Intracranial bleeding,Gastrointestinal bleeding)<br>9.Changes in resting ABI<br>10.Rutherford Classification Trends