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

N/ATerminatedNCT02043951

C. R. Bard59 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Peripheral Artery Disease

Interventions

Lutonix Drug Coated Balloon CatheterDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (8)

The Vein Institute of Toronto

Toronto, Ontario, Canada

Hospital Kuala Lumpur

Kuala Lumpur, Malaysia

Hospital Universiti Kebangsaan

Kuala Lumpur, Malaysia

Hospital Universiti Sains Malaysia

Kubang Kerian Kelantan, Malaysia

Outcomes

Primary Outcomes

Efficacy: Freedom from target lesion revascularization (TLR)

Time frame: 12 months

Safety

Freedom from the composite endpoint of target vessel revascularization (TVR), major amputation and major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis) of index limb and device- and procedure-related death.

Time frame: 30 Days

Secondary Outcomes

Acute Device Success

Device success is defined as, a per device basis, the achievement of successful delivery and deployment of the registry device(s) as intended at the intended target lesion, without balloon rupture or inflation/deflation abnormalities and a successful withdrawal of the registry system. If a device is inserted into the subject but not used due to user error (e.g. inappropriate balloon length or transit time too long) this device will not be included in the device success assessment.

Time frame: 30 days, 6 and 12 months

Procedural Success

Attainment of ≤30% residual stenosis by visual estimate in the treatment area above the knee and attainment of ≤50% residual stenosis by visual estimate in the treatment area below the knee without major adverse events during the index procedure.

Time frame: 30 days, 6 and 12 months

Freedom separately from each of the following adverse events listed below:

* All-cause death * Device- and procedure-related mortality * Unexpected device or drug-related AEs * Index limb amputation (major and minor reported separately) * Reintervention for treatment of thrombosis of the target vessel * Reintervention for embolization to its distal vasculature * TLR (at 6 months) * TVR * Composite of all-cause perioperative (≤30 day) death and from the following: index limb amputation, index limb reintervention, and index-limb-related death * Major amputation and major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis) of index limb.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.