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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

59 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Peripheral Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Single Arm: Lutonix Drug Coated Balloon

Lutonix Drug Coated Balloon Catheter

Intervention Type DEVICE

Interventions

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Lutonix Drug Coated Balloon Catheter

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No