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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02717104
Recruitment Status : Completed
First Posted : March 23, 2016
Last Update Posted : July 17, 2020
Sponsor:
Information provided by (Responsible Party):
C. R. Bard

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.

Condition or disease
Peripheral Artery Disease

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 249 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
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
Actual Study Start Date : August 20, 2015
Actual Primary Completion Date : March 2018
Actual Study Completion Date : June 2020



Primary Outcome Measures :
  1. Freedom from Target Lesion Revascularization [ Time Frame: 12 months ]
  2. Freedom from Target Vessel and Target Lesion Revascularization [ Time Frame: 30 days ]
  3. Freedom from Major Amputation and Major Reintervention of index limb [ Time Frame: 30 days ]
  4. Freedom from device- and procedure-related death [ Time Frame: 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
General patient pool of participating hospitals or clinics
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02717104


Locations
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Korea, Republic of
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, Korea, Republic of, 431-796
Myongji Hospital
Goyang-si, Gyeonggi-do, Korea, Republic of, 412-270
Soonchunjyang University Hospital
Bucheon, Gyeonggi, Korea, Republic of
Kangbuk Samsung Hospital
Seoul, Jongno-gu, Korea, Republic of
Busan Veterans Hospital
Busan, Korea, Republic of
Inje University Busan Park Hospital
Busan, Korea, Republic of
Keimyung University Dongsan Medical Center
Daegu, Korea, Republic of, 700-712
YeungNam University Medical Center
Daegu, Korea, Republic of, 705-703
Chungnam National University Hospital
Daejeon, Korea, Republic of, 301-721
Chonnam National University Hospital
Gwangju, Korea, Republic of, 501-757
Inha University Hospital
Incheon, Korea, Republic of, 400-711
Seoul National University Hospital
Seoul, Korea, Republic of, 110-799
Seoul St. Mary's Hospital
Seoul, Korea, Republic of, 137-040
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Konkuk University Hospital
Seoul, Korea, Republic of, 143-729
Ajou University Hospital
Suwon, Korea, Republic of, 443-380
Sponsors and Collaborators
C. R. Bard
Investigators
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Principal Investigator: Jae Kyu Kim, MD Chonnam National University
Additional Information:

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Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT02717104    
Other Study ID Numbers: KORL15100
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: July 17, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by C. R. Bard:
femoropopliteal
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases