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

Popliteal Artery Disease Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02698345
• Other study ID #: 1-2015-0081
• Status: Recruiting
• Start date: January 2016
• Est. completion date: March 2021

Study information

• Verified date: January 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Popliteal Artery Disease

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary patency rate	absence of restenosis >50% based on an imaging study (Duplex ultrasound, CT angiography or catheter angiography) at 12 months	12 months after the index procedure
Secondary	Target vessel revascularization rate	frequency of repeat intervention or surgical treatment due to loss of patency at the target vessel	12 months