Peripheral Artery DiseaseNCT02717104
Korean Post-market Registry Assessing the Clinical Use and Safety of the Lutonix DCB in Femoropopliteal Arteries
An observational study of Peripheral Artery Disease, run by C. R. Bard at 16 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Peripheral Artery Disease
- How many people
- 249 participants
- Where
- 16 sitesSouth Korea
- Study dates
- 20 Aug 2015to Jun 2020
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: General patient pool of participating hospitals or clinics
Who may be able to join
- ≥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)
Who cannot join
- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
South Korea16 sites
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, 431-796
Soonchunjyang University Hospital
Bucheon-si, Gyeonggi-do
Busan Veterans Hospital
Busan
Inje University Busan Park Hospital
Busan
Keimyung University Dongsan Medical Center
Daegu, 700-712
YeungNam University Medical Center
Daegu, 705-703
Chungnam National University Hospital
Daejeon, 301-721
Myongji Hospital
Goyang-si, Gyeonggi-do, 412-270
Chonnam National University Hospital
Gwangju, 501-757
Inha University Hospital
Incheon, 400-711
Kangbuk Samsung Hospital
Seoul, Jongno-gu
Seoul National University Hospital
Seoul, 110-799
Seoul St. Mary's Hospital
Seoul, 137-040
Asan Medical Center
Seoul, 138-736
Konkuk University Hospital
Seoul, 143-729
Ajou University Hospital
Suwon, 443-380
About this study
Official title: A Prospective, Multicenter, Single Arm, Post-Market Registry Assessing the Clinical Use and Safety of the LUTONIX Drug Coated Balloon Catheter in Femoropopliteal Arteries
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.
Read the 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
- Keywords
- femoropopliteal
- Medical subject headings
- Peripheral Arterial Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from Target Lesion Revascularization
Measured: 12 months
Freedom from Target Vessel and Target Lesion Revascularization
Measured: 30 days
Freedom from Major Amputation and Major Reintervention of index limb
Measured: 30 days
Freedom from device- and procedure-related death
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study start20 Aug 2015
- Primary completionMar 2018
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by C. R. BardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 249 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jae Kyu Kim, MD, Principal investigator, Chonnam National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02717104
- Sponsor's protocol ID
- KORL15100
- Status last verified
- Jul 2020
- First submitted
- 16 Mar 2016
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single Arm, Post-Market Registry Assessing the Clinical Use and Safety of the LUTONIX Drug Coated Balloon Catheter in Femoropopliteal Arteries
- ClinicalTrials.gov ID
- NCT02717104
- Acronym / sponsor ID
- KORL15100
- Conditions
- Peripheral Artery Disease
- Keywords
- femoropopliteal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- 20 Aug 2015 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 23 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- General patient pool of participating hospitals or clinics
Key inclusion criteria (6 listed)
- ≥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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Freedom from Target Lesion Revascularization
Time frame: 12 months
Freedom from Target Vessel and Target Lesion Revascularization
Time frame: 30 days
Freedom from Major Amputation and Major Reintervention of index limb
Time frame: 30 days
Freedom from device- and procedure-related death
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jae Kyu Kim, MD principal investigator
Chonnam National University
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Artery Disease, run by C. R. Bard at 16 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from Target Lesion Revascularization (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2020.