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Femoral Artery StenosisNCT02720003

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

A study testing LTX DCB in people with Femoral Artery Stenosis and Femoral Artery Occlusion, run by C. R. Bard at 14 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
LTX DCB
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
148 participants
Where
14 sitesChina
Study dates
Mar 2016to Aug 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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.).

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

China14 sites

  • Beijing Shijitan Hospital. CMU

    Beijing, Beijing Municipality, 100038

  • Chinese- PLA General Hospital

    Beijing, Beijing Municipality, 100853

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116011

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350005

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510260

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

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

    Nanjing, Jiangsu, 210008

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266003

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

    Shanghai, Shanghai Municipality, 200011

  • Zhongshan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200032

  • RENJI Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200127

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

  • General Hospital of Tianjin Medical University

    Tianjin

Other trials in China

About this study

Official title: 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.

Read the 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. .

Being tested
LTX DCB
Keywords
Atherosclerosis, Superficial Femoral Artery, Proximal Popliteal Artery
Medical subject headings
Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LTX DCBDevice

    Treatment with a drug-coated balloon

Study groups in NCT02720003
Study groupRoleWhat they receive
LTX DCBExperimentalPatients treated with Bard Lutonix DCB
Receives: Device: LTX DCB

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 0-12 months

  2. 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

    Measured: 0-30 days

Secondary outcomes (11)

  1. Device Success

    Measured: 1 month

  2. Technical Success

    Measured: 1 month

  3. Acute Technical Success

    Measured: 1 month

  4. Procedural Success

    Measured: 1 month

  5. Percentage of Subjects with Primary Patency of the Target Lesion

    Measured: 24 months

  6. Target Lesion Revascularization

    Proportion of subjects with target lesion revascularization through 24 months

    Measured: 24 months

  7. Change in Rutherford Classification

    Mean change in Rutherford Classification from baseline through 24 months

    Measured: 24 months

  8. Change in Ankle Brachial Index

    Mean change in ankle brachial index from baseline through 24 months

    Measured: 24 months

  9. Percentage of subjects who died from any cause

    Measured: 24 months

  10. Amputation-free Survival

    Percentage of subjects with above-the-ankle amputation-free survival

    Measured: 24 months

  11. Percentage of subjects with Target Vessel Revascularization

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionOct 2018
  4. Study completionAug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
148 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02720003
Sponsor's protocol ID
BC1401PV
Status last verified
Jan 2021
First submitted
26 Feb 2016
Last updated
20 Jan 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing LTX DCB in people with Femoral Artery Stenosis and Femoral Artery Occlusion, run by C. R. Bard at 14 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Efficacy - Percentage of Subjects With Primary Patency of the Target Lesion at One Year (time frame: 0-12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02720003.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.

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