Clinical trial NCT02043951: Use and Safety of the LUTONIX® Drug Coated Balloon Catheter in Arteries of the Lower Extremity
Official title: A Prospective, Multicenter, Single Arm, Post-Market, Real-World Global Registry Assessing the Clinical Use and Safety of the LUTONIX Drug Coated Balloon Catheter in Arteries of the Lower Extremity (LUTONIX® Lower Extremity Global (LEG) Registry)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Peripheral Artery Disease
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2014-01-23
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Real-world patients requiring drug coated balloon treatment.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy: Freedom from target lesion revascularization (TLR)
timeFrame: 12 months
measure: Safety
timeFrame: 30 Days
Secondary outcomes:
measure: Acute Device Success
timeFrame: 30 days, 6 and 12 months
measure: Procedural Success
timeFrame: 30 days, 6 and 12 months
measure: Freedom separately from each of the following adverse events listed below:
timeFrame: 30 days, 6 and 12 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Vein Institute of Toronto
state: Ontario
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: Hospital Universiti Kebangsaan
city: Kubang Kerian Kelantan
country: Malaysia
facility: Hospital Universiti Sains Malaysia
city: Sarawak
country: Malaysia
facility: Hospital Umum Sarawak
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Newtown, Wellington
country: New Zealand
facility: Wellington Regional Vascular Centre
city: Tauranga
country: New Zealand
facility: Tauranga Hospital
Study officials:
References: