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

Peripheral Artery Disease Clinical Trial

— LEG  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02043951
• Other study ID #: CL0015-01
• Status: Terminated
• Phase: Phase 3
• First received: January 17, 2014
• Last updated: July 12, 2016
• Start date: January 2014
• Est. completion date: January 2016

Study information

• Verified date: July 2016
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of Health
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 59
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Device:
• Lutonix Drug Coated Balloon Catheter

Locations

Country	Name	City	State
Canada	The Vein Institute of Toronto	Toronto	Ontario
Malaysia	Hospital Kuala Lumpur	Kuala Lumpur
Malaysia	Hospital Universiti Kebangsaan	Kuala Lumpur
Malaysia	Hospital Universiti Sains Malaysia	Kubang Kerian Kelantan
Malaysia	Hospital Umum Sarawak	Sarawak
New Zealand	Christchurch Hospital	Christchurch
New Zealand	Wellington Regional Vascular Centre	Newtown, Wellington
New Zealand	Tauranga Hospital	Tauranga

Sponsors (1)

Lead Sponsor	Collaborator
C. R. Bard

Countries where clinical trial is conducted

Canada,  Malaysia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Freedom from target lesion revascularization (TLR)		12 months	No
Primary	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.	30 Days	Yes
Secondary	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.	30 days, 6 and 12 months	No
Secondary	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.	30 days, 6 and 12 months	No
Secondary	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.	30 days, 6 and 12 months	No