A Prospective, Global Multicenter, Single Arm Real-World Registry Investigating the Clinical Use and Safety of the LUTONIX Drug Coated PTA Dilatation Catheter

C. R. Bard23 sites in 10 countries691 target enrollmentDecember 2012

ConditionsPeripheral Artery Disease

Overview

Phase: N/A
Intervention: Not specified
Conditions: Peripheral Artery Disease
Sponsor: C. R. Bard
Enrollment: 691
Locations: 23
Primary Endpoint: Freedom from Target Lesion Revascularization (TLR)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2012

End Date

September 2016

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

C. R. Bard

Responsible Party

Sponsor

Eligibility 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