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

NCT02698345 | Unknown

• 1 other identifier: 1-2015-0081
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Popliteal Artery Disease

Keywords

Popliteal artery disease, drug-eluting balloon, angioplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Target vessel revascularization rate

  12 months

Study Arms (1)

K-POP

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

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

Interventions

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

K-POP

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with isolated popliteal artery disease

You may qualify if:

• Age 19 years or older
• Symptomatic peripheral artery disease:
• Moderate or severe claudication (Rutherford category 2 or 3)
• Critical limb ischemia (Rutherford category 4 or 5)
• Atherosclerotic popliteal artery disease (stenosis \> 50%)
• Patients with signed informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

RECRUITING

Related Publications (1)

• Park JI, Ko YG, Lee SJ, Ahn CM, Rha SW, Yu CW, Park JK, Park SH, Lee JH, Kim SH, Lee YJ, Hong SJ, Kim JS, Kim BK, Hong MK, Choi D. Clinical Outcomes After Drug-Coated Balloon Treatment in Popliteal Artery Disease: K-POP Registry 12-Month Results. Korean Circ J. 2024 Aug;54(8):454-465. doi: 10.4070/kcj.2024.0006. Epub 2024 Apr 29.

  PMID: 38767445 DERIVED

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2016
• First Posted: March 3, 2016
• Study Start: January 1, 2016
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: January 18, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)