Clinical trial NCT02717104: Korean Post-market Registry Assessing the Clinical Use and Safety of the Lutonix DCB in Femoropopliteal Arteries
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Artery Disease
Keywords: femoropopliteal
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2016-03-23
Enrollment: 249
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General patient pool of participating hospitals or clinics

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.

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

Primary outcomes:
measure: Freedom from Target Lesion Revascularization
timeFrame: 12 months
measure: Freedom from Target Vessel and Target Lesion Revascularization
timeFrame: 30 days
measure: Freedom from Major Amputation and Major Reintervention of index limb
timeFrame: 30 days
measure: Freedom from device- and procedure-related death
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Anyang-si
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
state: Gyeonggi-do
city: Goyang-si
country: Korea, Republic of
facility: Myongji Hospital
state: Gyeonggi-do
city: Bucheon
country: Korea, Republic of
facility: Soonchunjyang University Hospital
state: Gyeonggi
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
state: Jongno-gu
city: Busan
country: Korea, Republic of
facility: Busan Veterans Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Busan Park Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: YeungNam University Medical Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Konkuk University Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
affiliation: Chonnam National University
name: Jae Kyu Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: