Lutonix Global SFA Registry

C. R. Bard

Status: Completed

Conditions: Peripheral Artery Disease

Treatments: Device: Lutonix Drug Coated Balloon

Study type: Observational

Funder types: Industry

Identifiers

NCT01864278

CL0004-01

Details and patient eligibility

About

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.

Enrollment: 691 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

691 participants in 1 patient group

Lutonix Drug Coated Balloon

Description:

Paclitaxel coated ballooncatheter

Treatment:

Device: Lutonix Drug Coated Balloon