Korean Post-market Registry Assessing the Clinical Use and Safety of the Lutonix DCB in Femoropopliteal Arteries
A Prospective, Multicenter, Single Arm, Post-Market Registry Assessing the Clinical Use and Safety of the LUTONIX Drug Coated Balloon Catheter in Femoropopliteal Arteries
1 other identifier
observational
249
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2015
Longer than P75 for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 20, 2015
CompletedFirst Submitted
Initial submission to the registry
March 16, 2016
CompletedFirst Posted
Study publicly available on registry
March 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedJuly 17, 2020
July 1, 2020
2.5 years
March 16, 2016
July 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Freedom from Target Lesion Revascularization
12 months
Freedom from Target Vessel and Target Lesion Revascularization
30 days
Freedom from Major Amputation and Major Reintervention of index limb
30 days
Freedom from device- and procedure-related death
30 days
Eligibility Criteria
General patient pool of participating hospitals or clinics
You may qualify if:
- ≥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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- C. R. Bardlead
Study Sites (16)
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, 431-796, South Korea
Soonchunjyang University Hospital
Bucheon-si, Gyeonggi-do, South Korea
Myongji Hospital
Goyang-si, Gyeonggi-do, 412-270, 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, 700-712, South Korea
YeungNam University Medical Center
Daegu, 705-703, South Korea
Chungnam National University Hospital
Daejeon, 301-721, South Korea
Chonnam National University Hospital
Gwangju, 501-757, South Korea
Inha University Hospital
Incheon, 400-711, South Korea
Seoul National University Hospital
Seoul, 110-799, South Korea
Seoul St. Mary's Hospital
Seoul, 137-040, South Korea
Asan Medical Center
Seoul, 138-736, South Korea
Konkuk University Hospital
Seoul, 143-729, South Korea
Ajou University Hospital
Suwon, 443-380, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jae Kyu Kim, MD
Chonnam National University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 24 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2016
First Posted
March 23, 2016
Study Start
August 20, 2015
Primary Completion
March 1, 2018
Study Completion
June 1, 2020
Last Updated
July 17, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share