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

• Conditions: Popliteal Artery Disease
• Interventions: Device: drug-eluting balloon (In.PACT Admiral, Medtronic)

• Registration Number: NCT02698345
• Lead Sponsor: Yonsei University

Brief Summary

* Prospective, multi-center, single-arm registry study

* A total of 100 subjects with isolated popliteal artery lesions according to inclusion and exclusion criteria will be enrolled.

* All popliteal artery lesions will be treated with drug-eluting balloon (In.PACT Admiral, Medtronic). • Atherectomy or use of bare nitinol stent in combination with drug-eluting balloon is allowed • Patients will be followed clinically for 12 months after the procedure.

* Imaging study (Duplex ultrasound, CT angiography or catheter angiography) follow-up will be performed at 12 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-02-29
• Study First Submitted QC: 2016-02-29
• Study First Posted: 2016-03-03
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-16
• Last Update Posted: 2019-01-18
• Primary Completion: 2021-03
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• 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%)

4. Patients with signed informed consent

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
K-POP	drug-eluting balloon (In.PACT Admiral, Medtronic)	Patients with isolated popliteal artery disease undergoing endovascular therapy using drug-eluting balloon (In.PACT Admiral, Medtronic)

Primary Outcome Measures

Name	Time	Method
Primary patency rate	12 months after the index procedure	absence of restenosis \>50% based on an imaging study (Duplex ultrasound, CT angiography or catheter angiography) at 12 months

Secondary Outcome Measures

Name	Time	Method
Target vessel revascularization rate	12 months	frequency of repeat intervention or surgical treatment due to loss of patency at the target vessel

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of