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

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

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

Study Overview

• Status: Completed
• Conditions: Femoral Artery Occlusion; Femoral Artery Stenosis; Stenosis of Popliteal Arteries; Occlusion of Popliteal Arteries
• Intervention / Treatment: Device: LTX DCB

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. .

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Tianjin, China
    • General Hospital of Tianjin Medical University
  • Beijing
    • Beijing, Beijing, China, 100038
      • Beijing Shijitan Hospital. CMU
    • Beijing, Beijing, China, 100853
      • Chinese- PLA General Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350005
      • The First Affiliated Hospital of Fujian Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510260
      • The Second Affiliated Hospital of Guangzhou Medical University
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • The Second Hospital of Hebei Medical University
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
  • Liaoning
    • Dalian, Liaoning, China, 116011
      • The First Affiliated Hospital of Dalian Medical University
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu Hospital of Shandong University
    • Qingdao, Shandong, China, 266003
      • The Affiliated Hospital of Qingdao University
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Zhongshan Hospital Fudan University
    • Shanghai, Shanghai, China, 200127
      • Renji Hospital Shanghai Jiaotong University School of Medicine
    • Shanghai, Shanghai, China, 200011
      • Shanghai Ninth People's Hosptial , Shanghai JiaoTong University School of Medicine
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LTX DCB; Patients treated with Bard Lutonix DCB	Device: LTX DCB; Treatment with a drug-coated balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Efficacy - Percentage of Subjects With Primary Patency of the Target Lesion at One Year	Primary Patency is defined as the absence of target lesion restenosis (defined by DUS peak systolic velocity ratio [PSVR] ≥2.5 and/or abnormal waveforms, as determined by an Independent Core Laboratory) and freedom from target lesion revascularization (TLR).	0-12 months
Primary Safety - Percentage of Subjects With Composite of Freedom From All-cause Peri-operative Death and Freedom From the Following: Index Limb Amputation, Index Limb Re-intervention, and Index-limb-related Death	Primary Safety - Percentage of Subjects With Composite of Freedom From All-cause Peri-operative Death and Freedom From the Following: Index Limb Amputation, Index Limb Re-intervention, and Index-limb-related Death	0-30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Success		1 month
Technical Success		1 month
Acute Technical Success		1 month
Procedural Success		1 month
Percentage of Subjects with Primary Patency of the Target Lesion		24 months
Target Lesion Revascularization	Proportion of subjects with target lesion revascularization through 24 months	24 months
Change in Rutherford Classification	Mean change in Rutherford Classification from baseline through 24 months	24 months
Change in Ankle Brachial Index	Mean change in ankle brachial index from baseline through 24 months	24 months
Percentage of subjects who died from any cause		24 months
Amputation-free Survival	Percentage of subjects with above-the-ankle amputation-free survival	24 months
Percentage of subjects with Target Vessel Revascularization		24 months

Collaborators and Investigators

• Sponsor: C. R. Bard
• Investigators: Principal Investigator: Lan Zhang, Renji Hospital; Principal Investigator: Wei Guo, Professor, Chinese PLA General Hospital; Principal Investigator: Weiguo Fu, Professor, Fudan University; Principal Investigator: Fuxian Zhang, Beijing Shijitan Hospital. CMU; Principal Investigator: Tong Qiao, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; Principal Investigator: Xinwu Lu, Shanghai Ninth People's Hosptial , Shanghai JiaoTong University School of Medicine; Principal Investigator: Feng Wang, The First Affiliated Hospital of Dalian Medical University; Principal Investigator: Pingfan Guo, First Affiliated Hospital of Fujian Medical University; Principal Investigator: Shaomang Lin, Second Affiliated Hospital of Guangzhou Medical University; Principal Investigator: Wei Bi, The Second Hospital of Hebei Medical University; Principal Investigator: Jianjun Jiang, Qilu Hospital of Shandong University; Principal Investigator: Xiangchen Dai, General Hospital of Tianjin Medical University

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): August 1, 2020

Study Registration Dates

• First Submitted: February 26, 2016
• First Submitted That Met QC Criteria: March 21, 2016
• First Posted (Estimate): March 25, 2016

Study Record Updates

• Last Update Posted (Actual): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 19, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Atherosclerosis; Superficial Femoral Artery; Proximal Popliteal Artery
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: BC1401PV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided