Korean Post-market Registry Assessing the Clinical Use and Safety of the Lutonix DCB in Femoropopliteal Arteries

NCT ID: NCT02717104

Last Updated: 2020-07-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 249 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-08-20
• Study Completion Date: 2020-06-30

Brief Summary

The purpose of the registry is to assess the clinical use and safety of the LUTONIX Drug Coated Balloon Catheter in a heterogeneous patient population in real world clinical practice.

Detailed Description

The registry will enroll patients with claudication or critical limb ischemia due to stenotic lesions in femoropopliteal arteries. All subjects meeting protocol criteria will be treated with the LUTONIX Drug Coated Balloon Catheter for approved indications according to the current Instructions for Use (IFU) and followed clinically for 2 years.

Total enrollment will be approximately 250 subjects at up to 18 sites. Subject follow-up will occur at 1, 6, 12 and 24 months. The primary efficacy endpoint is freedom from target lesion revascularization at 12 months.

The primary safety endpoint is freedom at 30 days from the composite endpoint of target vessel revascularization and target lesion revascularization, major amputation and major reintervention of index limb, and device- and procedure-related death.

Conditions

Peripheral Artery Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• ≥19 years of age
• Rutherford Clinical Category ≥4
• Patient or Legally Authorized Representative is willing to provide informed consent and comply with the required follow-up
• Stenotic or obstructive vascular lesions in femoropopliteal artery(s)
• Lesion(s) can be treated with available LUTONIX Drug Coated Balloon Catheter device size matrix per current IFU
• At least one patent native outflow artery to the ankle free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of outflow disease is NOT permitted; treatment of in-flow disease is permitted prior to treatment with the LUTONIX Drug Coated PTA Dilatation Catheter)

Exclusion Criteria

• Patient is currently participating in an active phase of another investigational drug or device study
• Inability to take recommended medications as stated in the IFU or non-controllable allergy to contrast
• Known inadequate distal outflow or planned future (within 30 days) treatment of vascular disease distal to the target lesion

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

C. R. Bard

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jae Kyu Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Chonnam National University

Locations

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, South Korea

Soonchunjyang University Hospital

Bucheon-si, Gyeonggi-do, South Korea

Myongji Hospital

Goyang-si, Gyeonggi-do, South Korea

Kangbuk Samsung Hospital

Seoul, Jongno-gu, South Korea

Busan Veterans Hospital

Busan, , South Korea

Inje University Busan Park Hospital

Busan, , South Korea

Keimyung University Dongsan Medical Center

Daegu, , South Korea

YeungNam University Medical Center

Daegu, , South Korea

Chungnam National University Hospital

Daejeon, , South Korea

Chonnam National University Hospital

Gwangju, , South Korea

Inha University Hospital

Incheon, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Seoul St. Mary's Hospital

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

Konkuk University Hospital

Seoul, , South Korea

Ajou University Hospital

Suwon, , South Korea

Countries

South Korea

Other Identifiers

KORL15100

Identifier Type: -

Identifier Source: org_study_id