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

Sponsor
Eximo Medical Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03157531
Collaborator
(none)
97
Enrollment
11
Locations
1
Arm
13.1
Actual Duration (Months)
8.8
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or DiseaseIntervention/TreatmentPhase
  • Device: B-Laser™ Atherectomy System
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
97 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Safety and Effectiveness Evaluation of Eximo Medical's B-Laser™ Atherectomy Device, in Subjects Affected With Infrainguinal PAD
Actual Study Start Date :
Sep 6, 2017
Actual Primary Completion Date :
Apr 27, 2018
Actual Study Completion Date :
Oct 11, 2018

Arms and Interventions

ArmIntervention/Treatment
Experimental: B-Laser™ Atherectomy System

B-Laser™ Atherectomy System

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

Outcome Measures

Primary Outcome Measures

  1. Acute Technical Success [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) [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 Outcome Measures

  1. 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]

    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 [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. [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) [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) [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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™.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Arkansas HeartLittle RockArkansasUnited States72211
2Orlando HealthAltamonte SpringsFloridaUnited States32714
3Cardiovascular solutions institute, Blake MCBradentonFloridaUnited States34208
4North Florida Regional Medical CenterGainesvilleFloridaUnited States32605
5UnityPoint Trinity Bettendorf , Genesis Health SystemDavenportIowaUnited States52803
6St. Louis Heart and VascularSaint LouisMissouriUnited States63136
7Holy Name Medical CenterTeaneckNew JerseyUnited States07666
8Wellmont CVA Heart InstituteKingsportTennesseeUnited States37660
9Medical University GrazGrazAustria8036
10Policlinico Abano TermeAbano TermeItaly35031
11Maria Cecilia HospitalCotignolaItaly48033

Sponsors and Collaborators

  • Eximo Medical Ltd.

Investigators

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

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Eximo Medical Ltd.
ClinicalTrials.gov Identifier:
NCT03157531
Other Study ID Numbers:
  • EX-PAD-03
First Posted:
May 17, 2017
Last Update Posted:
Jun 20, 2019
Last Verified:
May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitleB-Laser™ Atherectomy System
Arm/Group DescriptionB-Laser™ Atherectomy System B-Laser™ Atherectomy System: The B-Laser™ is indicated for use for atherectomy of infrainguinal stenoses
Period Title: Overall Study
STARTED97
Analyzed at 30 Days For MAEs93
COMPLETED91
NOT COMPLETED6

Baseline Characteristics

Arm/Group TitleB-Laser™ Atherectomy System
Arm/Group DescriptionB-Laser™ Atherectomy System B-Laser™ Atherectomy System: The B-Laser™ is indicated for use for atherectomy of infrainguinal stenoses
Overall Participants97
Overall Lesions107
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]
70.5
Sex: Female, Male (Count of Participants)
Female
46
47.4%
Male
51
52.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
6
6.2%
Not Hispanic or Latino
91
93.8%
Unknown or Not Reported
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
Asian
1
1%
Native Hawaiian or Other Pacific Islander
0
0%
Black or African American
13
13.4%
White
83
85.6%
More than one race
0
0%
Unknown or Not Reported
0
0%
Region of Enrollment (participants) [Number]
Austria
13
13.4%
United States
77
79.4%
Italy
7
7.2%
Rutherford class at baseline (scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [scores on a scale]
2.77
(0.60)
WIQ (Walking Impairment Questionnaire) at baseline (scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [scores on a scale]
0.23
(0.22)
ABI (Ankle Brachial Index) at baseline (ratio) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ratio]
0.71
(0.19)
Baseline Stenosis % at target lesion (by Core laboratory) (%) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [%]
85.7
(12.2)
Baseline Stenosis % at target lesion (by Core laboratory) (Lesions) [Count of Units]
Stenosis ≤ 95%
72
Stenosis > 95% and ≤ 99%
12
Chronic total occlusion (stenosis 100%)
23
Baseline Calcification level at target lesion (by Core laboratory) (Lesions) [Count of Units]
no
24
mild/moderate
55
severe
28
Target lesion length (by Core laboratory) (cm) [Mean (Full Range) ]
Mean (Full Range) [cm]
5.4

Outcome Measures

1. Primary Outcome
TitleAcute Technical Success
DescriptionReduction 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.
Time FramePerioperative

Outcome Measure Data

Analysis Population Description
Unavailable angiographic data for primary efficacy endpoint analysis for 2 participants with 2 lesions out of the 97 participants with 109 lesions (these 2 were considered ITT and not PP).
Arm/Group TitleB-Laser™ Atherectomy System
Arm/Group DescriptionB-Laser™ Atherectomy System B-Laser™ Atherectomy System: The B-Laser™ is indicated for use for atherectomy of infrainguinal stenoses
Measure Participants95
Measure lesions107
Mean (Standard Deviation) [Change in RDS (%)]
33.6
(14.2)
2. Primary Outcome
TitleNumber of Participants With Freedom From 30 Days Major Adverse Events (MAEs)
DescriptionUnplanned 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%.
Time Frame30 (+/-5) days post procedure

Outcome Measure Data

Analysis Population Description
1 Cardiovascular related death was unrelated to the device per the CEC. Four participants out of the 97 with unavailable data: two were lost to follow-up before the 30-day visit was completed, and two others had their 30-day visit outside of the allowable window (day 16 and day 23).
Arm/Group TitleB-Laser™ Atherectomy System
Arm/Group DescriptionB-Laser™ Atherectomy System B-Laser™ Atherectomy System: The B-Laser™ is indicated for use for atherectomy of infrainguinal stenoses
Measure Participants93
Count of Participants [Participants]
92
94.8%
3. Secondary Outcome
TitleNumber of Lesions With Freedom From Clinically Significant [1] Device Related Adverse Events (AEs) Requiring Intervention in the Target Vessel
DescriptionPerforation 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.
Time FramePerioperative and up to 30 (+/-5) days post procedure

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleB-Laser™ Atherectomy System
Arm/Group DescriptionB-Laser™ Atherectomy System B-Laser™ Atherectomy System: The B-Laser™ is indicated for use for atherectomy of infrainguinal stenoses
Measure Participants95
Measure lesions107
Count of Units [lesions]
107
4. Secondary Outcome
TitleNumber of Lesions With Freedom From Non-Clinically Significant [1] Device Related Adverse Events (AEs) in the Target Vessel
DescriptionPerforation 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.
Time FramePerioperative and up to 30 (+/-5) days post procedure

Outcome Measure Data

Analysis Population Description
All the 16 cases were type A (11) and B (5) dissections only. No perforations, major dissections, emboli or pseudoaneurysm.
Arm/Group TitleB-Laser™ Atherectomy System
Arm/Group DescriptionB-Laser™ Atherectomy System B-Laser™ Atherectomy System: The B-Laser™ is indicated for use for atherectomy of infrainguinal stenoses
Measure Participants95
Measure lesions107
Count of Units [lesions]
91
5. Secondary Outcome
TitleNumber of Lesions With Residual Stenosis by Angiography of ≤ 30% Post-procedure Including Any Adjunctive Therapy, With no Flow Limiting Dissection.
DescriptionNumber 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.
Time FramePerioperative

Outcome Measure Data

Analysis Population Description
Unavailable data for primary efficacy endpoint analysis for 2 participants out of the 97.
Arm/Group TitleB-Laser™ Atherectomy System
Arm/Group DescriptionB-Laser™ Atherectomy System B-Laser™ Atherectomy System: The B-Laser™ is indicated for use for atherectomy of infrainguinal stenoses
Measure Participants95
Measure lesions107
Yes
95
No
12
6. Secondary Outcome
TitlePAD Measurements at the 30-day Visit Post-procedure Compared to Baseline (1)
DescriptionRutherford 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.
Time Frame30 (+/-5) days post procedure

Outcome Measure Data

Analysis Population Description
Only available data for comparison at the two time-points is presented for each parameter .
Arm/Group TitleB-Laser™ Atherectomy System
Arm/Group DescriptionB-Laser™ Atherectomy System B-Laser™ Atherectomy System: The B-Laser™ is indicated for use for atherectomy of infrainguinal stenoses
Measure Participants94
Rutherford difference (30 day post-procedure - BL)
-1.79
(1.22)
WIQ difference (30 day post-procedure - BL)
0.26
(0.28)
7. Secondary Outcome
TitlePAD Measurements at the 30-day Visit Post-procedure Compared to Baseline (2)
Descriptionc) 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.
Time Frame30 (+/-5) days post procedure

Outcome Measure Data

Analysis Population Description
Only available data for comparison at the two time-points is presented for each parameter .
Arm/Group TitleB-Laser™ Atherectomy System
Arm/Group DescriptionB-Laser™ Atherectomy System B-Laser™ Atherectomy System: The B-Laser™ is indicated for use for atherectomy of infrainguinal stenoses
Measure Participants82
Mean (Standard Error) [ratio]
0.24
(0.18)
8. Secondary Outcome
TitleNumber of Lesions With Clinical Success at 30 Days
DescriptionDefined 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.
Time Frame30 (+/-5) days post procedure

Outcome Measure Data

Analysis Population Description
Unavailable PSVR for 13 participants (14 lesions) from 95 participants (107 lesions): 5 participants (6 lesions) not diagnostic due to technical incompliance at exam; 3 participants (3 lesions) lost to follow-up; 1 participant (1 lesion) died; 4 participants (4 lesions), core lab could not calculate PSVR, yet were considered patent by absolute PSV.
Arm/Group TitleB-Laser™ Atherectomy System
Arm/Group DescriptionB-Laser™ Atherectomy System B-Laser™ Atherectomy System: The B-Laser™ is indicated for use for atherectomy of infrainguinal stenoses
Measure Participants82
Measure lesions93
Count of Units [lesions]
90
9. Post-Hoc Outcome
TitleNumber of Participants With Freedom From 6 Months Major Adverse Events (MAEs) [Not a Study Pre-specified Endpoint]
DescriptionUnplanned target limb amputation above the ankle Clinically Driven Target Lesion Revascularization (CDTLR) Cardiovascular related deaths As adjudicated by the Clinical Event Committee (CEC).
Time Frame6 months (+/-14 days) post procedure

Outcome Measure Data

Analysis Population Description
3 CD-TLRs were possibly related to device & definitely related to index procedure, per CEC. 8 participants out of total 97 with unavailable data: 3 subjects were lost to follow-up before 6-month visit was completed, 1 subject died before 6-month visit, and 3 other subjects had their 6-month visit outside of the allowable window (before Day 166).
Arm/Group TitleB-Laser™ Atherectomy System
Arm/Group DescriptionB-Laser™ Atherectomy System B-Laser™ Atherectomy System: The B-Laser™ is indicated for use for atherectomy of infrainguinal stenoses
Measure Participants89
Count of Participants [Participants]
86
88.7%
10. Post-Hoc Outcome
TitlePAD Measurements at the 6-month Visit Post-procedure Compared to Baseline [Not a Study Pre-specified Endpoint] (1)
DescriptionRutherford 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.
Time Frame6-month (+/-14 days) post-procedure

Outcome Measure Data

Analysis Population Description
Only available data for comparison at the two time-points is presented for each parameter .
Arm/Group TitleB-Laser™ Atherectomy System
Arm/Group DescriptionB-Laser™ Atherectomy System B-Laser™ Atherectomy System: The B-Laser™ is indicated for use for atherectomy of infrainguinal stenoses
Measure Participants88
Rutherford difference (6 month post-procedure -BL)
-2.02
(1.12)
WIQ difference (6 month post-procedure -BL)
0.25
(0.30)
11. Post-Hoc Outcome
TitlePAD Measurements at the 6-month Visit Post-procedure Compared to Baseline [Not a Study Pre-specified Endpoint] (2)
Descriptionc) 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.
Time Frame6-month (+/-14 days) post-procedure

Outcome Measure Data

Analysis Population Description
Only available data for comparison at the two time-points is presented for each parameter .
Arm/Group TitleB-Laser™ Atherectomy System
Arm/Group DescriptionB-Laser™ Atherectomy System B-Laser™ Atherectomy System: The B-Laser™ is indicated for use for atherectomy of infrainguinal stenoses
Measure Participants79
Mean (Standard Error) [ratio]
0.17
(0.28)
12. Post-Hoc Outcome
TitleNumber of Lesions With 6-Month Patency [Not a Study Pre-specified Endpoint]
DescriptionDefined 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. This is not a study pre-specified endpoint.
Time Frame6 months (+/-14 days) post procedure

Outcome Measure Data

Analysis Population Description
Unavailable PSVR for 14 participants (17 lesions) from 95 participants (107 lesions): 3 participants (4 lesions) not diagnostic due to technical incompliance at exam; 5 participants (5 lesions) lost to follow-up; 2 participants (3 lesions) died; 4 participants (5 lesions), core lab could not calculate PSVR.
Arm/Group TitleB-Laser™ Atherectomy System
Arm/Group DescriptionB-Laser™ Atherectomy System B-Laser™ Atherectomy System: The B-Laser™ is indicated for use for atherectomy of infrainguinal stenoses
Measure Participants82
Measure lesions90
Count of Units [lesions]
77

Adverse Events

Time Frame6 months (+/-14 days) post procedure
Adverse Event Reporting Description All-Cause Mortality: 2 deaths were unrelated to the device, per the CEC Serious Adverse Events: 40/43 SAEs were unrelated to the device. Only 3 'Vascular disorders' SAEs were classified by CEC as 'possibly related' to device and 'definitely related' to procedure (all 3 were CDTLRs). Other (Not Including Serious) Adverse Events: 53/55 AEs were unrelated to the device. Only 2 'Vascular disorders' AEs were classified by CEC as 'possibly related' to device and 'definitely related' to procedure.
Arm/Group TitleB-Laser™ Atherectomy System
Arm/Group DescriptionB-Laser™ Atherectomy System B-Laser™ Atherectomy System: The B-Laser™ is indicated for use for atherectomy of infrainguinal stenoses
All Cause Mortality
B-Laser™ Atherectomy System
Affected / at Risk (%)# Events
Total2/93 (2.2%)
Serious Adverse Events
B-Laser™ Atherectomy System
Affected / at Risk (%)# Events
Total43/93 (46.2%)
Blood and lymphatic system disorders
Blood and lymphatic system disorders4/93 (4.3%) 4
Cardiac disorders
Cardiac disorders13/93 (14%) 13
General disorders
General disorders1/93 (1.1%) 1
Infections and infestations
Infections and infestations1/93 (1.1%) 1
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications2/93 (2.2%) 2
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders3/93 (3.2%) 3
Nervous system disorders
Nervous system disorders1/93 (1.1%) 1
Renal and urinary disorders
Renal and urinary disorders3/93 (3.2%) 3
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders2/93 (2.2%) 2
Vascular disorders
Vascular disorders13/93 (14%) 13
Other (Not Including Serious) Adverse Events
B-Laser™ Atherectomy System
Affected / at Risk (%)# Events
Total54/93 (58.1%)
Cardiac disorders
Cardiac disorders4/93 (4.3%) 4
Eye disorders
Eye disorders1/93 (1.1%) 1
General disorders
General disorders9/93 (9.7%) 9
Hepatobiliary disorders
Hepatobiliary disorders1/93 (1.1%) 1
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications9/93 (9.7%) 9
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders4/93 (4.3%) 4
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders4/93 (4.3%) 5
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders1/93 (1.1%) 1
Vascular disorders
Vascular disorders21/93 (22.6%) 21

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/TitleOshrat Cohen
OrganizationEximo Medical
Phone97286307639
Emailoshratc@eximomedical.com
Responsible Party:
Eximo Medical Ltd.
ClinicalTrials.gov Identifier:
NCT03157531
Other Study ID Numbers:
  • EX-PAD-03
First Posted:
May 17, 2017
Last Update Posted:
Jun 20, 2019
Last Verified:
May 1, 2019