Single versus dual antiplatelet therapy for feMOrOpopliTeal lesion treated witH paclItaxEl-eluting device.

JRCT ID: jRCTs031220617

Registered date:08/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Symptomatic arteriosclerosis obliterans
• Date of first enrollment: 27/12/2022
• Target sample size: 400
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: Primary patency rate of target lesions at 12 months after procedure

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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.)

Related Information

• Primary Sponsor: Soga Yoshimitsu
• Secondary Sponsor: General Incorporated Association Peripheral Vascular Regeneration Research Group LIBERAL