NCT02043951

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2014

Geographic Reach
3 countries

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 23, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

July 13, 2016

Status Verified

July 1, 2016

Enrollment Period

1.9 years

First QC Date

January 17, 2014

Last Update Submit

July 12, 2016

Conditions

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (2)

  • Efficacy: Freedom from target lesion revascularization (TLR)

    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.

    30 Days

Secondary Outcomes (3)

  • Acute Device Success

    30 days, 6 and 12 months

  • Procedural Success

    30 days, 6 and 12 months

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

    30 days, 6 and 12 months

Study Arms (1)

Single Arm: Lutonix Drug Coated Balloon

Device: Lutonix Drug Coated Balloon Catheter

Interventions

Lutonix Drug Coated Balloon CatheterDEVICE
Single Arm: Lutonix Drug Coated Balloon

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Real-world patients requiring drug coated balloon treatment.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

The Vein Institute of Toronto

Toronto, Ontario, M5R 1J3, Canada

Location

Hospital Kuala Lumpur

Kuala Lumpur, 50586, Malaysia

Location

Hospital Universiti Kebangsaan

Kuala Lumpur, 56000, Malaysia

Location

Hospital Universiti Sains Malaysia

Kubang Kerian Kelantan, 16150, Malaysia

Location

Hospital Umum Sarawak

Sarawak, 93586, Malaysia

Location

Christchurch Hospital

Christchurch, 8140, New Zealand

Location

Wellington Regional Vascular Centre

Newtown, Wellington, 6021, New Zealand

Location

Tauranga Hospital

Tauranga, 3110, New Zealand

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2014

First Posted

January 23, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

July 13, 2016

Record last verified: 2016-07

Locations

NZ(3)MY(4)CA(1)