Safety and Effectiveness of B-Laser™ in Subjects Affected With Infrainguinal PAD

May 26, 2019 updated by: Eximo Medical Ltd.

Safety and Effectiveness Evaluation of Eximo Medical's B-Laser™ Atherectomy Device, in Subjects Affected With Infrainguinal PAD

This is a prospective, single-arm, multi-center, international, open-label, clinical study.

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 aim of the study is to assess the safety and efficacy of the Eximo Medical's B-Laser™ Atherectomy catheter in subjects with infrainguinal Peripheral Artery Disease (PAD).

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.
97

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

  • Austria
      • Graz, Austria, 8036
        • Medical University Graz
  • Italy
      • Abano Terme, Italy, 35031
        • Policlinico Abano Terme
      • Cotignola, Italy, 48033
        • Maria Cecilia Hospital
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Arkansas Heart
    • Florida
      • Altamonte Springs, Florida, United States, 32714
        • Orlando Health
      • Bradenton, Florida, United States, 34208
        • Cardiovascular solutions institute, Blake MC
      • Gainesville, Florida, United States, 32605
        • North Florida Regional Medical Center
    • Iowa
      • Davenport, Iowa, United States, 52803
        • UnityPoint Trinity Bettendorf , Genesis Health System
    • Missouri
      • Saint Louis, Missouri, United States, 63136
        • St. Louis Heart and Vascular
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • Holy Name Medical Center
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Wellmont CVA Heart Institute

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

Description

Inclusion Criteria:

  1. Subject is ≥ 18 years old.
  2. Subject is a candidate for atherectomy for infrainguinal peripheral artery disease.
  3. Documented symptomatic atherosclerotic peripheral artery disease Rutherford Classification 2-4.
  4. Subject has an infrainguinal target lesion(s) with any type of stenosis (naïve recurrent, or in-stent) estimated to be ≥70% based on CT angiogram or any other imaging modality.
  5. Subject is capable and willing to comply with the scheduled follow up
  6. Subject or appropriate legal surrogate is able and willing to sign a written Informed Consent Form (ICF).

Intraoperative inclusion criteria (by fluoroscopy angiogram):

  1. Target lesion has a stenosis estimated to be ≥70%.

  2. In ATK subjects - at least one patent tibial run-off vessel into the foot

    -

Exclusion Criteria:

  1. Target lesion is in a vessel graft or synthetic graft.
  2. Target lesion length <1cm and >15 cm (in ISR cases could be >25cm).
  3. Endovascular or surgical procedure in the target limb performed less than or equal to 30 days prior to the index procedure OR Planned endovascular or surgical procedure 30 days after the index procedure.
  4. Intent to use other atherectomy device in the same procedure.
  5. Evidence or history of intracranial or gastrointestinal bleeding, intracranial aneurysm, myocardial infarction or stroke within the past 2 months.
  6. Evidence or history of aneurysm in the target vessel within the past 2 months.
  7. History of bleeding diathesis, coagulopathy or inability to accept blood transfusions.
  8. History of heparin-induced thrombocytopenia (HIT) or inability to tolerate antiplatelet medication(s), anticoagulation, or thrombolytic therapy.
  9. Subjects requiring dialysis.
  10. Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
  11. Serious illness that may affect subject compliance to protocol and 30-day follow-up.
  12. Participating in another clinical study
  13. Subject is pregnant or planning to become pregnant during the study period.
  14. Life expectancy < 12 months
  15. Any planned amputation above the ankle.

Intraoperative exclusion criteria (by fluoroscopy angiogram):

  1. Inability to intraluminally cross and secure a 0.014" wire across the target lesion.
  2. Target lesion length <1cm and >15 cm (in ISR cases >25cm).
  3. Reference vessel lumen diameter proximal to target lesion is <150% of the outer diameter of the B-LaserTM.

  4. Any clinical and/or angiographic complication prior to the planed insertion of B-laser™.

    -

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

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: B-Laser™ Atherectomy System
Device: B-Laser™ Atherectomy System
The B-Laser™ is indicated for use for atherectomy of infrainguinal stenoses

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
Acute Technical Success
Time Frame: Perioperative

Reduction from baseline in residual diameter stenosis (%), prior to any adjunctive therapy, achieved by the B-Laser™ catheter

A change (always a reduction) between two time points (baseline time-point and post B-Laser treatment time-point, both perioperative) is reported:

  • As assessed quantitatively by the core laboratory.
  • This endpoint will be met if the mean reduction in residual diameter stenosis is greater than 20%.
  • A greater reduction means better results.
Perioperative
Number of Participants With Freedom From 30 Days Major Adverse Events (MAEs)
Time Frame: 30 (+/-5) days post procedure
  1. Unplanned target limb amputation above the ankle
  2. Clinically Driven Target Lesion Revascularization (CDTLR)

  3. Cardiovascular related deaths

    • As adjudicated by the Clinical Event Committee (CEC).
    • This endpoint will be met if the freedom from MAE rate is greater than 85%.
30 (+/-5) days post procedure

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
Number of Lesions With Freedom From Clinically Significant [1] Device Related Adverse Events (AEs) Requiring Intervention in the Target Vessel
Time Frame: Perioperative and up to 30 (+/-5) days post procedure
  1. Perforation
  2. Dissection
  3. Distal embolization or in situ thrombus

  4. Pseudoaneurysm

    • As adjudicated by the Clinical Event Committee (CEC). [1] Note: Clinically Significant AEs are defined as adverse events that REQUIRE any intervention,treatment or any hospitalization or its prolongation, in order to prevent death, persistent/significant disability/incapacity or congenital anomaly/birth defect.
Perioperative and up to 30 (+/-5) days post procedure
Number of Lesions With Freedom From Non-Clinically Significant [1] Device Related Adverse Events (AEs) in the Target Vessel
Time Frame: Perioperative and up to 30 (+/-5) days post procedure
  1. Perforation
  2. Dissection
  3. Distal embolization or in situ thrombus

  4. Pseudoaneurysm

    • As adjudicated by the Clinical Event Committee (CEC). [1] Note: non-Clinically Significant AEs are defined as adverse events that DO NOT REQUIRE any intervention, treatment or any hospitalization or its prolongation, in order to prevent death, persistent/significant disability/incapacity or congenital anomaly/birth defect.
Perioperative and up to 30 (+/-5) days post procedure
Number of Lesions With Residual Stenosis by Angiography of ≤ 30% Post-procedure Including Any Adjunctive Therapy, With no Flow Limiting Dissection.
Time Frame: Perioperative

Number of Lesions with residual stenosis by angiography of ≤ 30% post-procedure including any adjunctive therapy, with no flow limiting dissection.

* As assessed quantitatively by the core laboratory.
Perioperative
PAD Measurements at the 30-day Visit Post-procedure Compared to Baseline (1)
Time Frame: 30 (+/-5) days post procedure
  1. Rutherford Classification: a doctor determined 7 stages scale (0= Asymptomatic, 6= Severe ischemic ulcers/frank gangrene) representing PAD progress, lower value = better outcome. Positive difference between time-points represents a clinical deterioration through time and vice versa.
  2. Walking Impairment Questionnaire (WIQ): a patient fulfilled survey to grade physical ability representing PAD progress, has 3 sub-scales (walking speed, distance, climbing stairs), when the total score ranges between 0-100, higher value = better outcome. Positive difference between time-points represents a clinical improvement through time and vice versa.
30 (+/-5) days post procedure
PAD Measurements at the 30-day Visit Post-procedure Compared to Baseline (2)
Time Frame: 30 (+/-5) days post procedure
c) Ankle-Brachial Index (ABI): ankle/arm blood pressure ratio. Normal value ranges between 0.9-1.3. Under 0.9 index means blood has a difficult time getting to legs & feet; 0.4-0.9 indicates mild-moderate PAD; 0.4 and lower indicates severe PAD. Positive difference between time-points represents a clinical improvement through time and vice versa.
30 (+/-5) days post procedure
Number of Lesions With Clinical Success at 30 Days
Time Frame: 30 (+/-5) days post procedure

Defined as < 50% stenosis at the treated lesion, as assessed quantitatively by duplex ultrasound when the peak systolic velocity ratio is < 2.5.

* As assessed quantitatively by the core laboratory.
30 (+/-5) days post procedure

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.
Eximo Medical Ltd.

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: John Rundback, Dr., Holy Name Medical Center, Teaneck, New Jersey, United States, 07666

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.
September 6, 2017

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.
April 27, 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.
October 11, 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).
May 16, 2017

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.
May 16, 2017

First Posted (ACTUAL)

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.
May 17, 2017

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.
June 20, 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.
May 26, 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.
May 1, 2019

More Information

Terms related to this study

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.
  • EX-PAD-03

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

Yes

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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