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

Yonsei University

Status: Unknown

Conditions: Popliteal Artery Disease

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

Study type: Observational

Funder types: Other

Identifiers

NCT02698345

1-2015-0081

Details and patient eligibility

About

• 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 19 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

100 participants in 1 patient group

K-POP

Description:

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

Treatment:

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