Lutonix Global SFA Registry

Completed

• Conditions: Peripheral Artery Disease
• Interventions: Device: Lutonix Drug Coated Balloon

• Registration Number: NCT01864278
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-05-21
• Study First Submitted QC: 2013-05-24
• Study First Posted: 2013-05-29
• Primary Completion: 2015-07
• Study Completion: 2016-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-07
• Last Update Posted: 2016-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 691

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lutonix Drug Coated Balloon	Lutonix Drug Coated Balloon	Paclitaxel coated ballooncatheter

Primary Outcome Measures

Name	Time	Method
Freedom from Target Lesion Revascularization (TLR)	12 months	Efficacy: Freedom from TLR at 12 months.
Freedom from Target Vessel Revascularization(TVR), major index limb amputation, and device- and procedure-related death	30 days	Safety: Freedom at 30 days from TVR, major index limb amputation, and device- and procedure-related death

Trial Locations

Locations (23)

Allgemeines Krankenhaus Wien; 🇦🇹 Vienna, Austria

ZNA Campus Middelheim; 🇧🇪 Antwerp, Belgium

CHU Le Bocage; 🇫🇷 Dijon, France

Karolinen Hospital Huesten; 🇩🇪 Arnsberg, Germany

Diakoniewerk Muenchen; 🇩🇪 Muenchen, Germany

Medinos Kliniken Sonneberg; 🇩🇪 Sonneberg, Germany

Kreiskrankenhaus Viechtach; 🇩🇪 Viechtach, Germany

Klinikum Weiden; 🇩🇪 Weiden, Germany

University General Hospital of Patras; 🇬🇷 Patras, Greece

AO Cardinal Massaia; 🇮🇹 Asti, Italy

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