Bard LifeStent and Lutonix DCB for Treatment of Long Lesions in Femoropopliteal Arteries

October 7, 2019 updated by: C. R. Bard

A Prospective, Multicenter, Single-Arm, Post-Market Study Using the Lutonix Drug Coated Balloon for Post-Dilatation of the Bard LifeStent Vascular Stent for Treatment of Long Lesions in Femoropopliteal Arteries

Objective of this study is to evaluate the safety and efficacy of Lutonix 035 Drug Coated Dilatation PTA Catheter with Bard LifeStent Vascular Stent (hereinafter referred to as LifeStent) for treatment of long (10-24 cm) lesions in the SFA and/or proximal popliteal artery.

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 observe subjects presenting with claudication or ischemic rest pain (Rutherford category 2-4) and long (10-24 cm in length) native lesions in the infra-inguinal segment (superficial femoral artery [SFA] and/or proximal popliteal artery) who are candidates for stenting and pre-/post-dilatation with Drug Coated Balloon (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.
Observational

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.
149

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

  • Germany
      • Arnsberg, Germany, 59755
        • Klinikum Arnsberg
      • Bad Bevensen, Germany, 29549
        • Herz- und Gefasszentrum Bad Bevensen
      • Bad Krozingen, Germany, 79189
        • Universitäts-Herzzentrum Freiburg Bad Krozingen
      • Hamburg, Germany, 22527
        • Angiologikum Hamburg
      • Immenstadt, Germany, 87509
        • Klinik Immenstadt
      • Kassel, Germany, 34125
        • Klinikum Kassel
      • Lübeck, Germany, 23538
        • UKSH - Campus Lübeck
      • Rosenheim, Germany, 83022
        • RoMed Klinikum Rosenheim
      • Sonneberg, Germany, 96515
        • Gefäßzentrum Sonneberg
      • Weiden, Germany, 92637
        • Klinikum Weiden
  • Greece
      • Patras, Greece, 26504
        • University General Hospital of Patras
  • Poland
      • Sanok, Poland, 38-500
        • SPZOZ Sanok

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospital Patients

Description

Inclusion Criteria: Subjects will be included if all of the following inclusion criteria apply:

  1. Age ≥18 years;
  2. The subject is legally competent and able to understand the information on the study, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the Informed Consent Form (ICF);
  3. Rutherford Category 2-4;
  4. Target de novo lesion(s) or non-stented restenotic lesion(s) has angiographic evidence of ≥50% stenosis or occlusion (by visual estimate) and is amenable to treatment with LifeStent® and Lutonix DCB;
  5. Patients must be able to be treated with Lutonix DCB and LifeStent®;
  6. Total Lutonix DCB treated segment(s) of 10-24 cm in length;
  7. Target vessel reference diameter is 4.0-7.0 mm (by visual estimate) and able to be treated with available device size matrix;
  8. At least one patent native outflow artery to the ankle free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of outflow disease is NOT permitted; treatment of in-flow disease is permitted prior to treatment with LifeStent®).
  9. No other prior vascular interventions (including contralateral limb) within 2 weeks before and/or planned 30 days after the protocol treatment, with the exception of remote common femoral patch angioplasty separated by at least 2 cm from the target lesion;
  10. Female subjects of childbearing potential have a negative urine or serum pregnancy test within 7 days prior to index procedure;
  11. 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 tibioperoneal trunk.

Exclusion Criteria:

  1. Pregnant, lactating, or planning on becoming pregnant or men intending to father children;
  2. Contraindication to Lutonix DCB or LifeStent® per current IFU;
  3. Life expectancy of <1 year;
  4. Inability to take required antiplatelet/anticoagulant medications per the LifeStent® and Lutonix DCB IFU, or known contraindication (including allergic reaction) or sensitivity to contrast media, nickel, titanium or tantalum that cannot be adequately managed with pre- and post-procedure medication;
  5. Intended treatment of outflow disease during the index procedure;
  6. Intended use of laser, atherectomy or cryoplasty during index procedure;
  7. Sudden symptom onset, acute vessel occlusion, or acute or subacute thrombus in target vessel;
  8. History of stroke within 3 months;
  9. History of myocardial infarction, thrombolysis or angina within 2 weeks of enrollment;
  10. Participation in an investigational drug or another investigational device study until this study's (Lutonix LifeStent® Study) primary endpoint is reached or previous enrollment in this study;
  11. Another medical condition, which, in the opinion of the Investigator, may cause the patient to be noncompliant with the CIP or confound data interpretation;
  12. Target vessel and/or lesion involves a previously placed stent.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Lutonix Drug Coated Balloon
Paclitaxel coated balloon catheter
Device: Lutonix Drug Coated Balloon
Subject will receive treatment with the Lutonix 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 patency at 12 months.
Time Frame: 12 months
Primary patency is defined as the absence of target lesion restenosis and freedom from target lesion revascularization.
12 months
Freedom from the composite endpoint of death, index limb amputation, and target vessel revascularization at 30 days.
Time Frame: 30 days
Freedom from the composite endpoint of death, index limb amputation, and target vessel revascularization at 30 days.
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
Procedural success
Time Frame: Immediately after Intervention
Defined as attainment of ≤30% residual stenosis by quantitative angiography immediately after intervention in the absence of peri-procedural complications.
Immediately after Intervention
Technical success
Time Frame: Immediately after intervention
Defined as attainment of ≤30% residual stenosis by quantitative angiography.
Immediately after intervention
Device success
Time Frame: Immediately after intervention
Defined as successful delivery of the DCB to the target lesion and performance when used according to the clinical investigational plan.
Immediately after intervention
Freedom from Target Lesion Revascularization after 30 days, and 6, 12 and 24 months post-index procedure.
Time Frame: 30 days, 6, 12 and 24 months
Absence of Target Lesion Revascularization.
30 days, 6, 12 and 24 months
Freedom from TVR after 30 days, and 6, 12 and 24 months post-index procedure.
Time Frame: 30 days, 6, 12 and 24 months
Absence of Target Vessel Revascularization.
30 days, 6, 12 and 24 months
Change in resting ankle brachial index (ABI) from baseline to 30 days, and 6, 12 and 24 months post-index procedure
Time Frame: 30 days, 6, 12 and 24 months
The ABI values will be recorded and compared to the baseline values. The ABI is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm. A ratio of 0.9-1.3 is in the normal range. Lower ratios indicate bad blood perfusion of the leg.
30 days, 6, 12 and 24 months
Change in Rutherford Classification from baseline to 30 days, and 6, 12 and 24 months post-index procedure
Time Frame: 30 days, 6, 12 and 24 months
Patients are enrolled with a Rutherford grade of 2-4 for their target leg. The Rutherford scale is an indicator for the severity of Peripheral Vascular Disease: 0 = no symptoms, 6 = functional foot is no longer salvageable (leading to foot amputation).
30 days, 6, 12 and 24 months
All-cause death
Time Frame: 30 days, 6, 12 and 24 months
Death by any cause will be counted.
30 days, 6, 12 and 24 months
Amputation (above the ankle)-free survival
Time Frame: 30 days, 6, 12 and 24 months
Amputations above the ankle of the target leg will be counted.
30 days, 6, 12 and 24 months
Target limb reintervention for treatment of thrombosis of target vessel or embolization to its distal vasculature
Time Frame: 30 days, 6, 12 and 24 months
Thrombosis in the target vessel and embolizations below the target lesion will be analazed separately from other stenoses.
30 days, 6, 12 and 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: Thomas Zeller, Prof.

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 (Actual)

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.
October 1, 2014

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.
September 1, 2017

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.
October 2, 2018

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).
October 28, 2014

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.
October 29, 2014

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.
October 30, 2014

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.
October 9, 2019

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.
October 7, 2019

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.
October 1, 2019

More Information

Terms related to this study

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.
  • CL0022-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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