Korean Multicenter Prospective Registry of In.PACT DEB for Isolated Popliteal Artery Disease (K-POP Study)

Not Applicable

Completed

• Conditions: Diseases of the circulatory system

• Registration Number: KCT0002955
• Lead Sponsor: Yonsei University Health System, Severance Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-10-31
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1) Age 19 years or older
2) Symptomatic peripheral artery disease:
- Moderate or severe claudication (Rutherford category 2 or 3)
- Critical limb ischemia (Rutherford category 4 or 5)
3) Atherosclerotic popliteal artery disease, stenosis > 50% Treated with InPACT DEB balloon
4) Patients with signed informed consent

Exclusion Criteria

1) Acute critical limb ischemia
2) Severe critical limb ischemia (Rutherford category 6)
3) Involvement of SFA disease with stenosis
4) Continous total occlusion of all proximal infrapopliteal arteries (origin of the anterior tibial artery or tibioperoneal trunk).
5) Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, or contrast agent
6) Age > 85 years
7) Severe hepatic dysfunction (> 3 times normal reference values)
8) Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
9) LVEF < 40% or clinically overt congestive heart failure
10) Pregnant women or women with potential childbearing
11) Life expectancy <1 year due to comorbidity
12) Previous bypass surgery or stenting for the target popliteal artery
13) Untreated inflow disease of the ipsilateral pelvic or femoropopliteal arteries (more than 50% stenosis or occlusion)

Study & Design

• Study Type: Observational Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary patency

Secondary Outcome Measures

Name	Time	Method
ankle-brachial index: ABI;Rutherford category;Target vessel revascularization rate