Use and Safety of the LUTONIX® Drug Coated Balloon Catheter in Arteries of the Lower Extremity (LEG)

C. R. Bard

Status: Terminated

Conditions: Peripheral Artery Disease

Treatments: Device: Lutonix Drug Coated Balloon Catheter

Study type: Observational

Funder types: Industry

Identifiers

NCT02043951

CL0015-01

Details and patient eligibility

About

The registry will enroll patients with claudication or critical limb ischemia and angiographically significant lesion(s) in arteries of the lower extremity. Subjects will be treated with the Lutonix® Drug Coated Balloon Catheter for approved indications according to the current country-specific Instructions for Use (IFU) and followed clinically for 1 year.

Full description

This post-market registry is intended to assess the clinical use and safety of the Lutonix® Drug Coated Balloon Catheter in a heterogeneous patient population in real world clinical practice. Up to 500 patients will be enrolled in order to allow identification and assessment of rare adverse events (AEs) as well as outcomes in subpopulations defined by subject and lesion characteristics. All subjects will be followed for 1 year.

This registry is performed with marketed devices within the indications for use. There are no additional treatments or exams that will take place within this registry.

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ≥ 18 years of age;
2. Rutherford Clinical Category ≤ 5;
3. Patient or Legally Authorized Representative is willing to provide informed consent and comply with the required follow up;
4. Stenotic or obstructive vascular lesions in artery(s) of the lower extremity;
5. Lesion(s) can be treated with available LUTONIX Drug Coated Balloon Catheter device size matrix per current country-specific IFU.

Exclusion criteria

1. Patient is currently participating in an active phase of another investigational drug or device study;
2. Inability to take recommended medications as stated in the IFU or non-controllable allergy to contrast.

Trial design

59 participants in 1 patient group

Single Arm: Lutonix Drug Coated Balloon

Treatment:

Device: Lutonix Drug Coated Balloon Catheter