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OpenTrials
Completed

NCT Number: NCT01864278

Lutonix Global SFA Registry

The registry will enroll patients with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery. Subjects will be treated with the LUTONIX Drug Coated PTA Dilatation Catheter carrying the CE Mark per current Instructions for Use(IFU) and followed clinically for a minimum of 2 years.

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Key information

Conditions

Peripheral Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Allgemeines Krankenhaus Wien, Vienna, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or non-pregnant female ≥18 years of age;
  • Rutherford Clinical Category ≤ 4;
  • Patient is willing to provide 5-year informed consent and comply with the required follow up;
  • Stenotic or obstructive vascular lesions of the femoropopliteal artery;
  • Lesion(s) can be treated with available LUTONIX Drug Coated PTA Dilatation Catheter device size matrix per current IFU;
  • At least one patent native outflow artery to the ankle free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of outflow disease is NOT permitted; treatment of in-flow disease is permitted prior to treatment with the LUTONIX Drug Coated PTA Dilatation Catheter).

Exclusion criteria

  • Patient is currently participating in an investigational drug or device study;
  • Inability to take recommended medications as stated in the IFU or non-controllable allergy to contrast;
  • Pregnant or planning on becoming pregnant or men intending to father a child;
  • Rutherford Class > 4
  • Known inadequate distal outflow or planned future treatment of vascular disease distal to the target lesion

Treatment and study plan

Lutonix Drug Coated Balloon

Device

Subject will receive treatment with the Lutonix Drug Coated Balloon

Primary outcomes

  1. Freedom from Target Lesion Revascularization (TLR)

    Time frame: 12 months

    Efficacy: Freedom from TLR at 12 months.

  2. Freedom from Target Vessel Revascularization(TVR), major index limb amputation, and device- and procedure-related death

    Time frame: 30 days

    Safety: Freedom at 30 days from TVR, major index limb amputation, and device- and procedure-related death

Sponsors and collaborators

Lead sponsor

C. R. Bard

Industry

Collaborators

  • Bard Ltd

Registry information

Official study title

A Prospective, Global Multicenter, Single Arm Real-World Registry Investigating the Clinical Use and Safety of the LUTONIX Drug Coated PTA Dilatation Catheter

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
May 29, 2013
Registry last updated
Nov 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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