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PADNCT03157531

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

A study testing B-Laser™ Atherectomy System in people with PAD, run by Eximo Medical Ltd. at 11 sites in 3 countries.

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

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

Who is it for?
Ages 18 years and older
Conditions the study is for
PAD
What is being tested?
B-Laser™ Atherectomy System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
97 participants
Where
11 sitesin 3 countries
Study dates
6 Sep 2017to 11 Oct 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject is ≥ 18 years old.
  • Subject is a candidate for atherectomy for infrainguinal peripheral artery disease.
  • Documented symptomatic atherosclerotic peripheral artery disease Rutherford Classification 2-4.
  • 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.
  • Subject is capable and willing to comply with the scheduled follow up
  • Subject or appropriate legal surrogate is able and willing to sign a written Informed Consent Form (ICF).
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  • Intraoperative inclusion criteria (by fluoroscopy angiogram):
  • Target lesion has a stenosis estimated to be ≥70%.
  • In ATK subjects - at least one patent tibial run-off vessel into the foot
  • -

Who cannot join

  • Target lesion is in a vessel graft or synthetic graft.
  • Target lesion length <1cm and >15 cm (in ISR cases could be >25cm).
  • 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.
  • Intent to use other atherectomy device in the same procedure.
  • Evidence or history of intracranial or gastrointestinal bleeding, intracranial aneurysm, myocardial infarction or stroke within the past 2 months.
  • Evidence or history of aneurysm in the target vessel within the past 2 months.
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  • History of bleeding diathesis, coagulopathy or inability to accept blood transfusions.
  • History of heparin-induced thrombocytopenia (HIT) or inability to tolerate antiplatelet medication(s), anticoagulation, or thrombolytic therapy.
  • Subjects requiring dialysis.
  • Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
  • Serious illness that may affect subject compliance to protocol and 30-day follow-up.
  • Participating in another clinical study
  • Subject is pregnant or planning to become pregnant during the study period.
  • Life expectancy < 12 months
  • Any planned amputation above the ankle.
  • Intraoperative exclusion criteria (by fluoroscopy angiogram):
  • Inability to intraluminally cross and secure a 0.014" wire across the target lesion.
  • Target lesion length <1cm and >15 cm (in ISR cases >25cm).
  • Reference vessel lumen diameter proximal to target lesion is <150% of the outer diameter of the B-LaserTM.
  • Any clinical and/or angiographic complication prior to the planed insertion of B-laser™.
  • -

Trial locations and contacts

11 sites in 3 countries.

11 sites in 3 countries

United States8 sites

  • Orlando Health

    Altamonte Springs, Florida, 32714

  • Cardiovascular solutions institute, Blake MC

    Bradenton, Florida, 34208

  • UnityPoint Trinity Bettendorf , Genesis Health System

    Davenport, Iowa, 52803

  • North Florida Regional Medical Center

    Gainesville, Florida, 32605

  • Wellmont CVA Heart Institute

    Kingsport, Tennessee, 37660

  • Arkansas Heart

    Little Rock, Arkansas, 72211

  • St. Louis Heart and Vascular

    St Louis, Missouri, 63136

  • Holy Name Medical Center

    Teaneck, New Jersey, 07666

Other trials in United States

Italy2 sites

  • Policlinico Abano Terme

    Abano Terme, 35031

  • Maria Cecilia Hospital

    Cotignola, 48033

Other trials in Italy

Austria1 site

  • Medical University Graz

    Graz, 8036

Other trials in Austria

About this study

Official title: 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.

Read the 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).

Conditions
PAD
Being tested
B-Laser™ Atherectomy System

What participants receive

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

  • B-Laser™ Atherectomy SystemDevice

    The B-Laser™ is indicated for use for atherectomy of infrainguinal stenoses

Study groups in NCT03157531
Study groupRoleWhat they receive
B-Laser™ Atherectomy SystemExperimentalB-Laser™ Atherectomy System
Receives: Device: B-Laser™ Atherectomy System

What is being measured

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

  1. Acute Technical Success

    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.

    Measured: Perioperative

  2. Number of Participants With Freedom From 30 Days Major Adverse Events (MAEs)

    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%.

    Measured: 30 (+/-5) days post procedure

Secondary outcomes (6)

  1. Number of Lesions With Freedom From Clinically Significant [1] Device Related Adverse Events (AEs) Requiring Intervention in the Target Vessel

    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.

    Measured: Perioperative and up to 30 (+/-5) days post procedure

  2. Number of Lesions With Freedom From Non-Clinically Significant [1] Device Related Adverse Events (AEs) in the Target Vessel

    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.

    Measured: Perioperative and up to 30 (+/-5) days post procedure

  3. Number of Lesions With Residual Stenosis by Angiography of ≤ 30% Post-procedure Including Any Adjunctive Therapy, With no Flow Limiting Dissection.

    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.

    Measured: Perioperative

  4. PAD Measurements at the 30-day Visit Post-procedure Compared to Baseline (1)

    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.

    Measured: 30 (+/-5) days post procedure

  5. PAD Measurements at the 30-day Visit Post-procedure Compared to Baseline (2)

    1. 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.

    Measured: 30 (+/-5) days post procedure

  6. Number of Lesions With Clinical Success at 30 Days

    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.

    Measured: 30 (+/-5) days post procedure

Timeline

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

  1. First posted17 May 2017
  2. Study start6 Sep 2017
  3. Primary completion27 Apr 2018
  4. Study completion11 Oct 2018

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
97 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03157531
Sponsor's protocol ID
EX-PAD-03
Status last verified
May 2019
First submitted
16 May 2017
Last updated
20 Jun 2019
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing B-Laser™ Atherectomy System in people with PAD, run by Eximo Medical Ltd. at 11 sites in 3 countries.

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 10 inclusion and 21 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 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States, Italy, Austria. 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?

Yes. Results are posted in the registry (first posted 20 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Acute Technical Success (time frame: Perioperative). 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 NCT03157531.

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 Jun 2019.

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