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Lutonix Global SFA Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01864278
Recruitment Status : Completed
First Posted : May 29, 2013
Last Update Posted : November 8, 2016
Sponsor:
Collaborator:
Bard Ltd
Information provided by (Responsible Party):
C. R. Bard

Brief Summary:
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.

Condition or disease Intervention/treatment
Peripheral Artery Disease Device: Lutonix Drug Coated Balloon

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Study Type : Observational [Patient Registry]
Actual Enrollment : 691 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: A Prospective, Global Multicenter, Single Arm Real-World Registry Investigating the Clinical Use and Safety of the LUTONIX Drug Coated PTA Dilatation Catheter
Study Start Date : December 2012
Actual Primary Completion Date : July 2015
Actual Study Completion Date : September 2016

Group/Cohort Intervention/treatment
Lutonix Drug Coated Balloon
Paclitaxel coated ballooncatheter
Device: Lutonix Drug Coated Balloon
Subject will receive treatment with the Lutonix Drug Coated Balloon




Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospital patients (global registry)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864278


Locations
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Austria
Allgemeines Krankenhaus Wien
Vienna, Austria, 1090
Belgium
ZNA Campus Middelheim
Antwerp, Belgium, 2020
France
CHU Le Bocage
Dijon, France, 21079
Germany
Karolinen Hospital Huesten
Arnsberg, Germany, 59759
Diakoniewerk Muenchen
Muenchen, Germany, 80331
Medinos Kliniken Sonneberg
Sonneberg, Germany, 96515
Kreiskrankenhaus Viechtach
Viechtach, Germany, 94234
Klinikum Weiden
Weiden, Germany, 92637
Greece
University General Hospital of Patras
Patras, Greece, 26504
Italy
AO Cardinal Massaia
Asti, Italy, 14100
IRCCS Policlinico San Donato
San Donato Milanese, Italy, 20097
Azienda Ospedaliera della Valtellina e dalla Valchiavenna
Sondalo, Italy, 23035
AO Ordine Mauriziano
Torino, Italy
Poland
Szpital Uniwersytecki nr 2 im. Biziel
Bydgoszcz, Poland, 85-168
Szpital Kliniczny Przemienienia Panskiego
Poznan, Poland, 61-848
Voivodship Specialist Hospital
Torun, Poland, 87-100
Spain
Hospital Clinico Barcelona
Barcelona, Spain, 08036
Switzerland
Kantonsspital Aarau
Aarau, Switzerland, 5001
United Kingdom
Royal Liverpool
Liverpool, United Kingdom, L7 8XP
St Thomas' Hospital
London, United Kingdom, SE1 7EH
Manchester Royal Infirmary
Manchester, United Kingdom, M13 9WL
Wythenshawe Hospital
Manchester, United Kingdom, M23 9LT
Freeman Hospital
Newcastle upon Tyne, United Kingdom, WE7 7DN
Sponsors and Collaborators
C. R. Bard
Bard Ltd

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT01864278     History of Changes
Other Study ID Numbers: CL0004-01
First Posted: May 29, 2013    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases