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

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: Completed
• Conditions: PAD
• Intervention / Treatment: Device: B-Laser™ Atherectomy System

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: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

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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™.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	Perioperative
Number of Participants With Freedom From 30 Days Major Adverse Events (MAEs)	Unplanned target limb amputation above the ankle; Clinically Driven Target Lesion Revascularization (CDTLR); Cardiovascular related deathsAs 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

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	Perforation; Dissection; Distal embolization or in situ thrombus; PseudoaneurysmAs 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	Perforation; Dissection; Distal embolization or in situ thrombus; PseudoaneurysmAs 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.	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)	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.	30 (+/-5) days post procedure
PAD Measurements at the 30-day Visit Post-procedure Compared to Baseline (2)	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	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

• Sponsor: Eximo Medical Ltd.
• Investigators: Principal Investigator: John Rundback, Dr., Holy Name Medical Center, Teaneck, New Jersey, United States, 07666

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 6, 2017
• Primary Completion (ACTUAL): April 27, 2018
• Study Completion (ACTUAL): October 11, 2018

Study Registration Dates

• First Submitted: May 16, 2017
• First Submitted That Met QC Criteria: May 16, 2017
• First Posted (ACTUAL): May 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 20, 2019
• Last Update Submitted That Met QC Criteria: May 26, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID 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