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Completed

NCT Number: NCT03157531

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

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

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Key information

Conditions

PAD

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University Graz, Graz, Austria

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

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

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Exclusion criteria

  • 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.
  • 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™.

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Treatment and study plan

B-Laser™ Atherectomy System

Device

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

Primary outcomes

  1. 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.

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

    Time frame: 30 (+/-5) days post procedure

    • Unplanned target limb amputation above the ankle
    • Clinically Driven Target Lesion Revascularization (CDTLR)
    • 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%.

Secondary outcomes

  1. 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

    • Perforation
    • Dissection
    • Distal embolization or in situ thrombus
    • 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.

  2. 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

    • Perforation
    • Dissection
    • Distal embolization or in situ thrombus
    • 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.

  3. 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.

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

    Time frame: 30 (+/-5) days post procedure

    • 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.
    • 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Eximo Medical Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 17, 2017
Registry last updated
Jun 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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