Lutonix Global SFA Registry

Peripheral Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01864278
• Other study ID #: CL0004-01
• Status: Completed
• Phase: N/A
• First received: May 21, 2013
• Last updated: November 7, 2016
• Start date: December 2012
• Est. completion date: September 2016

Study information

• Verified date: November 2016
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionPoland: Ethics CommitteeAustria: EthikkommissionSwitzerland: EthikkommissionFrance: Commission nationale de l'informatique et des libertésItaly: Ethics CommitteeGreece: Ethics CommitteeNetherlands: Independent Ethics CommitteeBelgium: Ethics CommitteeSpain: Ethics CommitteeUnited Kingdom: National Health Service
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 691
• Est. completion date: September 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Device:
• Lutonix Drug Coated Balloon
Subject will receive treatment with the Lutonix Drug Coated Balloon

Locations

Country	Name	City	State
Austria	Allgemeines Krankenhaus Wien	Vienna
Belgium	ZNA Campus Middelheim	Antwerp
France	CHU Le Bocage	Dijon
Germany	Karolinen Hospital Huesten	Arnsberg
Germany	Diakoniewerk Muenchen	Muenchen
Germany	Medinos Kliniken Sonneberg	Sonneberg
Germany	Kreiskrankenhaus Viechtach	Viechtach
Germany	Klinikum Weiden	Weiden
Greece	University General Hospital of Patras	Patras
Italy	AO Cardinal Massaia	Asti
Italy	IRCCS Policlinico San Donato	San Donato Milanese
Italy	Azienda Ospedaliera della Valtellina e dalla Valchiavenna	Sondalo
Italy	AO Ordine Mauriziano	Torino
Poland	Szpital Uniwersytecki nr 2 im. Biziel	Bydgoszcz
Poland	Szpital Kliniczny Przemienienia Panskiego	Poznan
Poland	Voivodship Specialist Hospital	Torun
Spain	Hospital Clinico Barcelona	Barcelona
Switzerland	Kantonsspital Aarau	Aarau
United Kingdom	Royal Liverpool	Liverpool
United Kingdom	St Thomas' Hospital	London
United Kingdom	Manchester Royal Infirmary	Manchester
United Kingdom	Wythenshawe Hospital	Manchester
United Kingdom	Freeman Hospital	Newcastle upon Tyne

Sponsors (2)

Lead Sponsor	Collaborator
C. R. Bard	Bard Ltd

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Germany,  Greece,  Italy,  Poland,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from Target Lesion Revascularization (TLR)	Efficacy: Freedom from TLR at 12 months.	12 months	Yes
Primary	Freedom from Target Vessel Revascularization(TVR), major index limb amputation, and device- and procedure-related death	Safety: Freedom at 30 days from TVR, major index limb amputation, and device- and procedure-related death	30 days	Yes