NCT03739580
Unknown
Not Applicable
The Comparison of Drug-coated Balloon With Stent Deployment in Popliteal Atherosclerotic Occlusive Lesions
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Popliteal Stenosis
- Sponsor
- Xuanwu Hospital, Beijing
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Salvage limb rate (for CLI patients)
- Last Updated
- 7 years ago
Overview
Brief Summary
This is a randomized prospective study aiming to compare drug-coated balloons and stent deployment in Popliteal atherosclerotic occlusive lesions.
Investigators
Yong-Quan Gu
Director, vascular suregry department
Xuanwu Hospital, Beijing
Eligibility Criteria
Inclusion Criteria
- •Age 18 years or older
- •Symptomatic peripheral artery disease:
- •Moderate or severe claudication (Rutherford category 2 or 3)
- •Critical limb ischemia (Rutherford category 4 or 5)
- •Atherosclerotic popliteal artery disease (stenosis \> 50%)
- •Patients with signed informed consent
Exclusion Criteria
- •Acute critical limb ischemia
- •Severe critical limb ischemia (Rutherford category 6)
- •Involvement of SFA disease with stenosis
- •Continous total occlusion of all proximal infrapopliteal arteries (origin of the anterior tibial artery or tibioperoneal trunk).
- •Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, or contrast agent
- •Age \> 80 years
- •Severe hepatic dysfunction (\> 3 times normal reference values)
- •Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
- •LVEF \< 40% or clinically overt congestive heart failure
- •Pregnant women or women with potential childbearing
Outcomes
Primary Outcomes
Salvage limb rate (for CLI patients)
Time Frame: 12 months after the index procedure
Limb Salvage is defined as the freedom from secondary major amputation
Primary patency of claudicant patients
Time Frame: 12 months after the index procedure
Claudicant patients (Rutherford C1-3), primary patency defined as PSVR（peak systolic velocity ratio) ≤2.4, absence of restenosis \>50% based on an imaging study (Duplex ultrasound, CT angiography or catheter angiography) at 12 months
Secondary Outcomes
- TcpO2(12 months)
- Wagnar classification(12 months)
- ABI(12 months)
- Index Limb Ischemia at 12-month Follow up(12 months)
- Rutherford classification(12 months)
- Major Adverse Events at 12-month Post Procedure(12 months)
- Target vessel revascularization rate(12 months)
Study Sites (1)
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