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

NCT03157531 | Completed Results DMC FDA Device

• 1 other identifier: EX-PAD-03
• Study Type: interventional
• Target: 97
• Locations: 3 countries
• Sites: 11

Brief Summary

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

Conditions

PAD

Outcome Measures

Primary Outcomes (2)

• 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)

  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 Outcomes (6)

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

  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

  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.

  Perioperative

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

  30 (+/-5) days post procedure

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

  30 (+/-5) days post procedure

Study Arms (1)

B-Laser™ Atherectomy System

EXPERIMENTAL

B-Laser™ Atherectomy System

Device: B-Laser™ Atherectomy System

Interventions

B-Laser™ Atherectomy System DEVICE

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

B-Laser™ Atherectomy System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Target lesion has a stenosis estimated to be ≥70%.
• In ATK subjects - at least one patent tibial run-off vessel into the foot

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eximo Medical Ltd.: lead

Study Sites (11)

Arkansas Heart

Little Rock, Arkansas, 72211, United States

Location

Orlando Health

Altamonte Springs, Florida, 32714, United States

Location

Cardiovascular solutions institute, Blake MC

Bradenton, Florida, 34208, United States

Location

North Florida Regional Medical Center

Gainesville, Florida, 32605, United States

Location

UnityPoint Trinity Bettendorf , Genesis Health System

Davenport, Iowa, 52803, United States

Location

St. Louis Heart and Vascular

St Louis, Missouri, 63136, United States

Location

Holy Name Medical Center

Teaneck, New Jersey, 07666, United States

Location

Wellmont CVA Heart Institute

Kingsport, Tennessee, 37660, United States

Location

Medical University Graz

Graz, 8036, Austria

Location

Policlinico Abano Terme

Abano Terme, 35031, Italy

Location

Maria Cecilia Hospital

Cotignola, 48033, Italy

Location

Results Point of Contact

• Title: Oshrat Cohen
• Organization: Eximo Medical

oshratc@eximomedical.com

97286307639

Study Officials

• John Rundback, Dr.

  Holy Name Medical Center, Teaneck, New Jersey, United States, 07666

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 17, 2017
• Study Start: September 6, 2017
• Primary Completion: April 27, 2018
• Study Completion: October 11, 2018
• Last Updated: June 20, 2019
• Results First Posted: June 20, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2); AU (1); US (8)