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

January 19, 2021 updated by: C. R. Bard

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
148

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary Efficacy - Percentage of Subjects With Primary Patency of the Target Lesion at One Year
Time Frame: 0-12 months
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
Time Frame: 0-30 days
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Device Success
Time Frame: 1 month
1 month
Technical Success
Time Frame: 1 month
1 month
Acute Technical Success
Time Frame: 1 month
1 month
Procedural Success
Time Frame: 1 month
1 month
Percentage of Subjects with Primary Patency of the Target Lesion
Time Frame: 24 months
24 months
Target Lesion Revascularization
Time Frame: 24 months
Proportion of subjects with target lesion revascularization through 24 months
24 months
Change in Rutherford Classification
Time Frame: 24 months
Mean change in Rutherford Classification from baseline through 24 months
24 months
Change in Ankle Brachial Index
Time Frame: 24 months
Mean change in ankle brachial index from baseline through 24 months
24 months
Percentage of subjects who died from any cause
Time Frame: 24 months
24 months
Amputation-free Survival
Time Frame: 24 months
Percentage of subjects with above-the-ankle amputation-free survival
24 months
Percentage of subjects with Target Vessel Revascularization
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
C. R. Bard

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BC1401PV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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