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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2021-03-31

Brief Summary

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* 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.

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Detailed Description

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Conditions

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Popliteal Artery Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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K-POP

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

drug-eluting balloon (In.PACT Admiral, Medtronic)

Intervention Type DEVICE

Interventions

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drug-eluting balloon (In.PACT Admiral, Medtronic)

Intervention Type DEVICE

Eligibility Criteria

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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

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)

Minimum Eligible Age

19 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No