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

NCT ID: NCT02720003

Last Updated: 2021-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2020-08-31

Brief 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.

Detailed Description

The study will enroll patients presenting with claudication or ischemic rest pain due to stenotic lesions in the superficial femoral or popliteal artery and a patent outflow artery to the foot. After successful pre-dilatation, subjects determined by the investigator not to require stenting based on defined angiographic criteria will receive the BARD LTX DCB. .

Conditions

Femoral Artery Stenosis; Femoral Artery Occlusion; Stenosis of Popliteal Arteries; Occlusion of Popliteal Arteries

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LTX DCB

Patients treated with Bard Lutonix DCB

Group Type: EXPERIMENTAL

LTX DCB

Intervention Type: DEVICE

Treatment with a drug-coated balloon

Interventions

LTX DCB

Treatment with a drug-coated balloon

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Male or female ≥18 and < 85 years of age;
• Documented diagnosis of peripheral arterial disease (PAD) with Rutherford Classification stages 2-4;
• Patient is willing to provide informed consent and comply with the required - follow up visits, testing schedule and medication regimen;

Angiographic Criteria

• Single lesion or up to two focal lesions (not separated by >3 cm) (total vessel segment length ≤20 cm) in native superficial femoral and/or popliteal arteries;
• ≥70% diameter stenosis by visual estimate;
• Lesion location starts ≥1 cm below the common femoral bifurcation and terminates distally ≤2 cm below the tibial plateau AND ≥1 cm above the origin of the TP trunk;
• De novo lesion(s) or non-stented restenotic lesion(s) >90 days from prior angioplasty procedure;
• Lesion is located at least 3 cm from any stent, if target vessel was previously stented;
• Target vessel diameter between ≥4 and ≤7 mm and able to be treated with available device size matrix;
• Successful, uncomplicated (without use of a crossing device) antegrade wire crossing of lesion;
• A patent inflow artery free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of target lesion acceptable after successful treatment of inflow iliac and/or common femoral artery lesions);
• No vascular interventions, surgical or interventional procedures within 2 weeks before and/or planned 30 days after the protocol treatment.

Exclusion Criteria

Patients will be excluded if ANY of the following conditions apply:

• Breastfeeding or pregnant or planning on becoming pregnant or men intending to father children;
• Life expectancy of < 2 year;
• Patient is currently participating in an investigational drug or other device study or previously enrolled in this study;
• History of stroke within 3 months;
• History of MI, thrombolysis or angina within 2 weeks of enrollment;
• Renal failure or chronic kidney disease with MDRD GFR ≤30 ml/min per 1.73 m2 (or serum creatinine ≥2.5 mg/dL within 30 days of index procedure or treated with dialysis);
• Diagnosed active systemic infection or uncontrolled coagulopathy within 14 days prior to index procedure
• Prior vascular surgery of the index limb, with the exception of remote common femoral patch angioplasty separated by at least 2 cm from the target lesion;
• Inability to take required study medications or allergy to paclitaxel or paclitaxel related compounds or contrast that cannot be adequately managed with pre- and post-procedure medication;
• The lesion is a post-DCB restenosis, or within or adjacent to an aneurysm; Ipsilateral retrograde access;
• There is no normal proximal arterial segment in which duplex flow velocity can be measured;
• Known inadequate distal outflow (≥50% stenosis of distal popliteal and/or all three tibial vessels;), or planned future treatment of vascular disease distal to the target lesion;
• Sudden symptom onset, acute vessel occlusion, or acute or sub-acute thrombus in target vessel;
• Severe calcification that renders the lesion un-dilatable or failed pre-dilatation, defined by a residual stenosis >50% or major flow limiting dissection;
• Use of adjunctive treatment modalities (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, embolic protection device, etc.).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

C. R. Bard

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wei Guo, Professor

Role: PRINCIPAL_INVESTIGATOR

Chinese PLA General Hospital

Weiguo Fu, Professor

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Fuxian Zhang

Role: PRINCIPAL_INVESTIGATOR

Beijing Shijitan Hospital. CMU

Tong Qiao

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Lan Zhang

Role: PRINCIPAL_INVESTIGATOR

RenJi Hospital

Xinwu Lu

Role: PRINCIPAL_INVESTIGATOR

Shanghai Ninth People's Hosptial , Shanghai JiaoTong University School of Medicine

Feng Wang

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Dalian Medical University

Pingfan Guo

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Fujian Medical University

Shaomang Lin

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital of Guangzhou Medical University

Wei Bi

Role: PRINCIPAL_INVESTIGATOR

The Second Hospital of Hebei Medical University

Jichun Zhao

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Jianjun Jiang

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital of Shandong University

Haofu Wang

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Hospital of Qingdao University

Xiangchen Dai

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University General Hospital

Locations

Beijing Shijitan Hospital. CMU

Beijing, Beijing Municipality, China

Chinese- PLA General Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Shanghai Ninth People's Hosptial , Shanghai JiaoTong University School of Medicine

Shanghai, Shanghai Municipality, China

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

RENJI Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

General Hospital of Tianjin Medical University

Tianjin, , China

Countries

China

Other Identifiers

BC1401PV

Identifier Type: -

Identifier Source: org_study_id