Clinical Trials Directory

Trials / Terminated

TerminatedNCT02813577

Lutonix Drug Coated Balloon for Treatment of Femoropopliteal Arteries in United States Females (CONFIRM)

A Prospective, Multicenter, Single Arm, Post-Approval Study of the Lutonix Drug Coated Balloon for Treatment of Femoropopliteal Arteries in United States Females

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
4 (actual)
Sponsor
C. R. Bard · Industry
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

The post approval study will enroll US female patients presenting with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery. Subjects are treated per Instructions For Use (IFU) with the Lutonix® Catheter. Subjects will have a Duplex Ultrasound (DUS) and clinical follow-up through two (2) years.

Detailed description

The Lutonix® 035 Drug Coated Balloon PTA Catheter (Lutonix® Catheter) has been approved by the Food and Drug Administration (P130024) for percutaneous transluminal angioplasty, after appropriate vessel preparation of de novo, restenotic, or in-stent restenotic lesions up to 300 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-7 mm. The purpose of this post-approval study is to assess the safety and effectiveness of the Lutonix® Catheter in the US female population. This study will enroll approximately 165 female patients at a minimum of 10 US centers and a maximum of 25.

Conditions

Interventions

TypeNameDescription
DEVICELutonix® 035 Drug Coated Balloon PTA CatheterFemale subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter.

Timeline

Start date
2018-04-20
Primary completion
2019-02-18
Completion
2019-02-18
First posted
2016-06-27
Last updated
2020-04-24
Results posted
2020-04-24

Locations

4 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT02813577. Inclusion in this directory is not an endorsement.