A Single Arm Trial Evaluating the BARD Lutonix Drug-Coated Balloon (LTX DCB) for Treatment of Femoropopliteal Arteries

Summary

To assess the safety and efficacy of the BARD LTX DCB for treatment of stenosis or occlusion of the superficial femoral and popliteal arteries.

Conditions

• Femoral Artery Stenosis
• Femoral Artery Occlusion
• Stenosis of Popliteal Arteries
• Occlusion of Popliteal Arteries

Interventions

DEVICE

LTX DCB

Treatment with a drug-coated balloon

Sponsors & Collaborators

• C. R. Bard

  lead INDUSTRY

Principal Investigators

• Wei Guo, Professor · Chinese PLA General Hospital

• Weiguo Fu, Professor · Fudan University

• Fuxian Zhang · Beijing Shijitan Hospital. CMU

• Tong Qiao · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

• Lan Zhang · RenJi Hospital

• Xinwu Lu · Shanghai Ninth People's Hosptial , Shanghai JiaoTong University School of Medicine

• Feng Wang · The First Affiliated Hospital of Dalian Medical University

• Pingfan Guo · First Affiliated Hospital of Fujian Medical University

• Shaomang Lin · Second Affiliated Hospital of Guangzhou Medical University

• Wei Bi · The Second Hospital of Hebei Medical University

• Jichun Zhao · West China Hospital

• Jianjun Jiang · Qilu Hospital of Shandong University

• Haofu Wang · The Affiliated Hospital of Qingdao University

• Xiangchen Dai · Tianjin Medical University General Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-03-31

Primary Completion

2018-10-31

Completion

2020-08-31

Countries

• China

Study Locations