About this trial
This study is a multicenter, prospective, observational research project. It is anticipated to enroll a total of 6,000 patients between February 1, 2025, and January 31, 2028 (with completion of one-year postoperative follow-up by January 31, 2029). Patients will be grouped according to different combinations of anticoagulant and antiplatelet drugs used postoperatively for PAD. The types, dosages, and duration of postoperative anticoagulant and antiplatelet drug use will be recorded. Follow-up assessments will be conducted at 1 month, 6 months, and 12 months postoperatively to document the occurrence of Major Adverse Cardiovascular Events (MACE) and Major Adverse Limb Events (MALE) in the enrolled patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. History of PAD, or a history of intermittent claudication with an ankle/brachial blood pressure ratio < 0.9, or angiography-confirmed significant peripheral arterial stenosis (≥50%).
Disqualifiers
1. **Patients with a history of stroke within the past month** or a history of hemorrhagic or lacunar stroke.
Trial population
Patients undergoing endovascular treatment for lower extremity arteriosclerosis obliterans
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Composite Adverse Event Rate (MACE/MALE): Myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation due to vascular disease.
MACE (Major Adverse Cardiovascular Events): Includes acute myocardial infarction, severe arrhythmia, heart failure, ischemic stroke, and death. Follow-up and recording will be conducted at 1 month, 6 months, and 12 months postoperatively. MALE (Major Adverse Limb Events): Includes major amputation, bleeding events (such as cerebral hemorrhage and gastrointestinal bleeding), and reintervention of the ipsilateral lower limb artery. Assessments will be performed at 1 month, 6 months, and 12 months postoperatively.
Secondary outcomes
MACE(Major Adverse Cardiovascular Events)
MACE (Major Adverse Cardiovascular Events): Includes acute myocardial infarction, severe arrhythmia, heart failure, ischemic stroke, and death. Follow-up and recording will be conducted at 1 month, 6 months, and 12 months postoperatively
Other outcomes
MALE(Major Adverse Limb Events)
MALE (Major Adverse Limb Events): Includes major amputation, bleeding events (such as cerebral hemorrhage and gastrointestinal bleeding), and reintervention of the ipsilateral lower limb artery. Assessments will be performed at 1 month, 6 months, and 12 months postoperatively.
Composite Freedom from Vascular Adverse Events
Composite Freedom from Vascular Adverse Events refers to the absence of any of the aforementioned events (MACE, MALE, or major bleeding) during the follow-up period.
All-Cause Mortality
All-cause mortality refers to death from any cause.
Locations
Sponsors and contacts
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