Peripheral Artery Disease
Conditions
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.
Interventions
Subject will receive treatment with the Lutonix Drug Coated Balloon
Sponsors
Bard Ltd
C. R. Bard
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Austria, Belgium, France, Germany, Greece, Italy, Poland, Spain, Switzerland, United Kingdom
Outcome results
None listed