This trial has been completed.

Condition peripheral artery disease
Treatment lutonix drug coated balloon
Sponsor C. R. Bard
Collaborator Bard Ltd
Start date December 2012
End date July 2015
Trial size 691 participants
Trial identifier NCT01864278, CL0004-01


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Paclitaxel coated ballooncatheter
lutonix drug coated balloon
Subject will receive treatment with the Lutonix Drug Coated Balloon

Primary Outcomes

Freedom from Target Lesion Revascularization (TLR)
time frame: 12 months
Freedom from Target Vessel Revascularization(TVR), major index limb amputation, and device- and procedure-related death
time frame: 30 days

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by C. R. Bard.