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

Peripheral Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02717104
• Other study ID #: KORL15100
• Status: Completed
• Start date: August 20, 2015
• Est. completion date: June 2020

Study information

• Verified date: July 2020
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: June 2020
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Sacred Heart Hospital	Anyang-si	Gyeonggi-do
Korea, Republic of	Soonchunjyang University Hospital	Bucheon	Gyeonggi
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	YeungNam University Medical Center	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Myongji Hospital	Goyang-si	Gyeonggi-do
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Kangbuk Samsung Hospital	Seoul	Jongno-gu
Korea, Republic of	Konkuk University Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul St. Mary's Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
C. R. Bard

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from Target Lesion Revascularization		12 months
Primary	Freedom from Target Vessel and Target Lesion Revascularization		30 days
Primary	Freedom from Major Amputation and Major Reintervention of index limb		30 days
Primary	Freedom from device- and procedure-related death		30 days