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CompletedNCT02556255Updated Mar 3, 2021Results posted

Safety and Effectiveness Study of Eximo's B-Laser™ Atherectomy Device for PAD Treatment

An interventional study of B-Laser™ Atherectomy Catheter in Peripheral Arterial Disease, sponsored by Eximo Medical Ltd.. Completed at 2 sites in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-03.

Sponsored by Eximo Medical Ltd. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
57
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The aim of the study is to assess the safety and efficacy of the use of the Eximo's B-Laser™ catheter in subjects affected with Peripheral Artery Disease (PAD) in lower extremity arteries.

Read the detailed description

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

All enrolled subjects will undergo atherectomy procedure, during which the B-Laser™ catheter will be used to perform atherectomy in target lesion, followed by any other adjunctive therapy (balloon and/or stent etc.). The procedure will be done according to standard hospital procedure for atherectomy. The steps of the operation before and after the operating of the B-Laser™ device are routinely used practice and will be done according to local practice at each hospital. For the post-atherectomy stage, as an adjunctive therapy in the procedure, any approved device may be used (balloon and/or stent etc.).

Subjects will then be followed for 12 months after the procedure.

02

Conditions studied

  • Peripheral Arterial Disease

Keywords

  • Peripheral Arterial Disease
  • Peripheral Artery Disease
  • PAD
  • Atherosclerosis
  • Arterial Occlusive Diseases
  • Peripheral Vascular Diseases
  • PVD
03

In context

Peripheral Arterial Disease

1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.

This study's enrollment of 57 is below the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.

Browse Peripheral Arterial Disease studies →

Lead sponsor

Eximo Medical Ltd. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Subject is ≥ 18 years old.
  2. Subject is a candidate for endovascular intervention for peripheral artery disease in the lower extremities.
  3. Documented symptomatic atherosclerotic peripheral artery disease Rutherford Classification 2-4.
  4. Subject has infrainguinal target lesion(s) with any type of stenosis (naïve or recurrent) estimated to be ≥70% based on CT angiogram or other imaging modality.
  5. At least one patent tibial run-off vessel at baseline.
  6. Subject is capable and willing to comply with the scheduled follow up.
  7. Subject is able and willing to sign a written informed consent form (ICF).

Intraoperative inclusion criteria (by fluoroscopy angiogram):

  1. Reference vessel lumen diameter proximal to target lesion is ≥150% of the outer diameter of the B-Laser™ to be used.
  2. Target lesion has been crossed with a guidewire within the true lumen.
  3. Target lesion has a stenosis estimated to be ≥70%.

Exclusion criteria

Exclusion Criteria:

  1. Target lesion is in a vessel graft or synthetic graft.
  2. Target lesion length >25 cm.
  3. Endovascular or surgical procedure 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. Flow limiting dissection proximal to, distal to or in the target lesion.
  6. Evidence or history of intracranial or gastrointestinal bleeding, intracranial aneurysm, myocardial infarction or stroke within the past 2 months.
  7. Evidence or history of aneurysm in the target vessel within the past 2 months.
  8. History of bleeding diathesis, coagulopathy or inability to accept blood transfusions.
  9. History of heparin-induced thrombocytopenia (HIT).
  10. Significant acute or chronic kidney disease with a creatinine level >2.5 mg/dl, and/or requiring dialysis.
  11. Any thrombolytic therapy within 2 weeks of the index procedure.
  12. History of severe trauma, fracture, major surgery or biopsy of a parenchymal organ within the past 14 days.
  13. Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
  14. Subjects in whom anti-platelet, anticoagulant, or thrombolytic therapy is contraindicated.
  15. Serious illness that may affect subject compliance to protocol and at a minimum the 30-day follow-up.
  16. Participating in other clinical study that involves any kind of intervention, including pharmaceutical.
  17. Issue that in the judgment of the investigator, may affect the results of the study.
  18. Subject is pregnant or planning to become pregnant during the study period.

Intraoperative exclusion criteria (by fluoroscopy angiogram):

  1. Total occlusion of the Target lesion that cannot be crossed in the true lumen by 0.014" GW.
  2. Target lesion length >25 cm.
  3. Reference vessel lumen diameter proximal to target lesion is \<150% of the outer diameter of the B-Laser™.
  4. Any clinical and/or angiographic complication attributed to the use of another device prior to the study procedure.
  5. Flow limiting dissection proximal, distal or in the target lesion.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
57 participants (actual)

Study arms

  • Experimental
    B-Laser™ Atherectomy Catheter

    Percutaneous Transluminal Angioplasty (PTA) for treatment of infrainguinal arteries in patients with Peripheral Artery Disease (PAD), that the atherectomy part of the PTA will include an experimental atherectomy catheter, B-Laser™.

    Device: B-Laser™ Atherectomy Catheter

Interventions

  • DeviceB-Laser™ Atherectomy Catheter

    Laser atherectomy catheter based on 355 nm

06

What researchers measure

Primary outcomes

  1. Number of Participants With 30 Day Freedom From Major Adverse Events

    1. Need for emergency surgical revascularization of the target limb 2. Unplanned target limb amputation above the ankle 3. Clinically driven Target Lesion Revascularization (TLR) 4. Cardiovascular related deaths

    Time frame: 30 days post procedure

  2. Number of Participants With Perioperative (Until Discharge) Freedom From Device/Procedure* Related Adverse Events (1)

    (\*NOTE: Device- or procedure-related AE refers only to the ATHERECTOMY PROCEDURE (with B-Laser™) and not the entire index procedure.) 1. Clinically Significant Perforations requiring intervention 2. Clinically Significant Dissections requiring intervention 3. Clinically Significant Embolus requiring intervention 4. Clinically Pseudo-aneurysm requiring intervention

    Time frame: Perioperative (until discharge), an average of 6 days

  3. Number of Lesions With Technical Success Rate: the Ability of the B-Laser™ Catheter to Cross the Target Lesion Stenosis Over the Wire.

    The technical success will be evaluated visually by the performing physician during procedure by fluoroscopy. It is evaluated per lesion and not per subject

    Time frame: Intraoperative (during the index procedure, after B-Laser™ catheter crossing, before adjunctive therapy)

Secondary outcomes

  1. Number of Participants With Perioperative (Until Discharge) Freedom From Device/Procedure* Related Adverse Events (2)

    (\*NOTE: Device- or Procedure-related AE Refers Only to the ATHERECTOMY PROCEDURE (With B-Laser™) and Not the Entire Index Procedure.) 1. Emboli, defined as a new occlusion of any visualized runoff vessel which cannot be reversed with an intravascular vasodilator 2. Flow limiting dissection

    Time frame: Perioperative (until discharge), an average of 6 days

  2. Number of Participants With 30 Day Freedom From Device/Procedure* Related Adverse Events

    (\*NOTE: Device- or Procedure-related AE Refers Only to the ATHERECTOMY PROCEDURE (With B-Laser™) and Not the Entire Index Procedure.) 1. Clinically Significant Dissections requiring intervention 2. Clinically Significant Embolus requiring intervention 3. Clinically Pseudo-aneurysm requiring intervention

    Time frame: 30 days post procedure

  3. Number of Lesions With Post-intervention Residual Diameter Stenosis of <30% With Adjunctive Therapy Assessed by Fluoroscopic Angiography in Cases Where Adjunctive Therapy is Medically Applicable

    The ability of the B-Laser™ catheter to achieve a post-intervention residual diameter stenosis of \<30% with adjunctive therapy assessed by fluoroscopic angiography in cases where adjunctive therapy is medically applicable

    Time frame: Intraoperative (at the end of the index procedure, after the last adjunctive therapy, e.g. last balloon or last stent)

  4. Change in Ankle-Brachial Index (ABI) Post B-Laser™ Device Procedure Compared to Baseline

    Change in Ankle-Brachial Index (ABI) post B-Laser™ device procedure compared to baseline. ABI is calculated as the ratio of the ankle blood pressure to the arm blood pressure. The normal value ranges between 0.9 to 1.3. The change is calculated as the value at the later time point minus the value at the earlier time point, when positive results represent increases while negative results represent decrease, so higher ABI score at the later time point represents an improvement through time and vice versa.

    Time frame: baseline and 30 days, 6 months and 12 months post procedure

  5. Change in Rutherford Classification Post B-Laser™ Device Procedure Compared to Baseline

    Change in Rutherford Classification Post B-Laser™ Device Procedure Compared to Baseline. Rutherford Classification has seven stages, from Stage 0 to Stage 6, when the lower value indicate a better outcome: 0= Asymptomatic; 1= Mild claudication; 2= Moderate claudication; 3= Severe claudication; 4= Rest pain; 5= Ischemic ulceration not exceeding ulcer of the digits of the foot; 6= Severe ischemic ulcers or frank gangrene. The change is calculated as the value at the later time point minus the value at the earlier time point, when positive results represent decrease while negative results represent increases, so lower Rutherford score at the later time point represents an improvement through time and vice versa.

    Time frame: baseline and 30 days, 6 months and 12 months post procedure

  6. Change in Grade of Walking Impairment Questionnaire (WIQ) Post B-Laser™ Device Procedure Compared to Baseline

    Change in Grade of Walking Impairment Questionnaire (WIQ) Post B-Laser™ Device Procedure Compared to Baseline. WIQ score ranges from 0-100 with higher score indicating a better walking outcomes. The change is calculated as the value at the later time point minus the value at the earlier time point, when positive results represent increases while negative results represent decrease, so higher WIQ score at the later time point represents an improvement through time and vice versa.

    Time frame: baseline and 30 days, 6 months and 12 months post procedure

07

Results

Posted Feb 21, 2019

Participant flow

Participant flow — Overall Study
MilestoneB-Laser™ Atherectomy Catheter
Started50
Completed46
Not completed4
Withdrew: Lost to follow-up4

Outcome measures

PrimaryNumber of Participants With 30 Day Freedom From Major Adverse Events

1. Need for emergency surgical revascularization of the target limb 2. Unplanned target limb amputation above the ankle 3. Clinically driven Target Lesion Revascularization (TLR) 4. Cardiovascular related deaths

Time frame:
30 days post procedure
Reported as:
Count of participants · Participants
Number of Participants With 30 Day Freedom From Major Adverse Events
ParticipantsB-Laser™ Atherectomy Catheter
Number of Participants With 30 Day Freedom From Major Adverse Events50
PrimaryNumber of Participants With Perioperative (Until Discharge) Freedom From Device/Procedure* Related Adverse Events (1)

(\*NOTE: Device- or procedure-related AE refers only to the ATHERECTOMY PROCEDURE (with B-Laser™) and not the entire index procedure.) 1. Clinically Significant Perforations requiring intervention 2. Clinically Significant Dissections requiring intervention 3. Clinically Significant Embolus requiring intervention 4. Clinically Pseudo-aneurysm requiring intervention

Time frame:
Perioperative (until discharge), an average of 6 days
Reported as:
Count of participants · Participants
Number of Participants With Perioperative (Until Discharge) Freedom From Device/Procedure* Related Adverse Events (1)
ParticipantsB-Laser™ Atherectomy Catheter
Number of Participants With Perioperative (Until Discharge) Freedom From Device/Procedure* Related Adverse Events (1)50
PrimaryNumber of Lesions With Technical Success Rate: the Ability of the B-Laser™ Catheter to Cross the Target Lesion Stenosis Over the Wire.

The technical success will be evaluated visually by the performing physician during procedure by fluoroscopy. It is evaluated per lesion and not per subject

Time frame:
Intraoperative (during the index procedure, after B-Laser™ catheter crossing, before adjunctive therapy)
Reported as:
Count of units · lesions
Number of Lesions With Technical Success Rate: the Ability of the B-Laser™ Catheter to Cross the Target Lesion Stenosis Over the Wire.
lesionsB-Laser™ Atherectomy Catheter
Number of Lesions With Technical Success Rate: the Ability of the B-Laser™ Catheter to Cross the Target Lesion Stenosis Over the Wire.52
SecondaryNumber of Participants With Perioperative (Until Discharge) Freedom From Device/Procedure* Related Adverse Events (2)

(\*NOTE: Device- or Procedure-related AE Refers Only to the ATHERECTOMY PROCEDURE (With B-Laser™) and Not the Entire Index Procedure.) 1. Emboli, defined as a new occlusion of any visualized runoff vessel which cannot be reversed with an intravascular vasodilator 2. Flow limiting dissection

Time frame:
Perioperative (until discharge), an average of 6 days
Reported as:
Count of participants · Participants
Number of Participants With Perioperative (Until Discharge) Freedom From Device/Procedure* Related Adverse Events (2)
ParticipantsB-Laser™ Atherectomy Catheter
Number of Participants With Perioperative (Until Discharge) Freedom From Device/Procedure* Related Adverse Events (2)50
SecondaryNumber of Participants With 30 Day Freedom From Device/Procedure* Related Adverse Events

(\*NOTE: Device- or Procedure-related AE Refers Only to the ATHERECTOMY PROCEDURE (With B-Laser™) and Not the Entire Index Procedure.) 1. Clinically Significant Dissections requiring intervention 2. Clinically Significant Embolus requiring intervention 3. Clinically Pseudo-aneurysm requiring intervention

Time frame:
30 days post procedure
Reported as:
Count of participants · Participants
Number of Participants With 30 Day Freedom From Device/Procedure* Related Adverse Events
ParticipantsB-Laser™ Atherectomy Catheter
Number of Participants With 30 Day Freedom From Device/Procedure* Related Adverse Events50
SecondaryNumber of Lesions With Post-intervention Residual Diameter Stenosis of <30% With Adjunctive Therapy Assessed by Fluoroscopic Angiography in Cases Where Adjunctive Therapy is Medically Applicable

The ability of the B-Laser™ catheter to achieve a post-intervention residual diameter stenosis of \<30% with adjunctive therapy assessed by fluoroscopic angiography in cases where adjunctive therapy is medically applicable

Time frame:
Intraoperative (at the end of the index procedure, after the last adjunctive therapy, e.g. last balloon or last stent)
Reported as:
Count of units · lesions
Number of Lesions With Post-intervention Residual Diameter Stenosis of <30% With Adjunctive Therapy Assessed by Fluoroscopic Angiography in Cases Where Adjunctive Therapy is Medically Applicable
lesionsB-Laser™ Atherectomy Catheter
Number of Lesions With Post-intervention Residual Diameter Stenosis of <30% With Adjunctive Therapy Assessed by Fluoroscopic Angiography in Cases Where Adjunctive Therapy is Medically Applicable38
SecondaryChange in Ankle-Brachial Index (ABI) Post B-Laser™ Device Procedure Compared to Baseline

Change in Ankle-Brachial Index (ABI) post B-Laser™ device procedure compared to baseline. ABI is calculated as the ratio of the ankle blood pressure to the arm blood pressure. The normal value ranges between 0.9 to 1.3. The change is calculated as the value at the later time point minus the value at the earlier time point, when positive results represent increases while negative results represent decrease, so higher ABI score at the later time point represents an improvement through time and vice versa.

Time frame:
baseline and 30 days, 6 months and 12 months post procedure
Reported as:
Mean · ratio
Change in Ankle-Brachial Index (ABI) Post B-Laser™ Device Procedure Compared to Baseline
ratioB-Laser™ Atherectomy Catheter
baseline0.57 ± 0.14
30 days0.94 ± 0.14
6 months0.84 ± 0.20
12 months0.77 ± 0.16
SecondaryChange in Rutherford Classification Post B-Laser™ Device Procedure Compared to Baseline

Change in Rutherford Classification Post B-Laser™ Device Procedure Compared to Baseline. Rutherford Classification has seven stages, from Stage 0 to Stage 6, when the lower value indicate a better outcome: 0= Asymptomatic; 1= Mild claudication; 2= Moderate claudication; 3= Severe claudication; 4= Rest pain; 5= Ischemic ulceration not exceeding ulcer of the digits of the foot; 6= Severe ischemic ulcers or frank gangrene. The change is calculated as the value at the later time point minus the value at the earlier time point, when positive results represent decrease while negative results represent increases, so lower Rutherford score at the later time point represents an improvement through time and vice versa.

Time frame:
baseline and 30 days, 6 months and 12 months post procedure
Reported as:
Count of participants · Participants
Change in Rutherford Classification Post B-Laser™ Device Procedure Compared to Baseline
ParticipantsB-Laser™ Atherectomy Catheter
baseline — Rutherford class 00
baseline — Rutherford class 10
baseline — Rutherford class 210
baseline — Rutherford class 335
baseline — Rutherford class 45
30 days — Rutherford class 024
30 days — Rutherford class 121
30 days — Rutherford class 23
30 days — Rutherford class 32
30 days — Rutherford class 40
6 months — Rutherford class 023
6 months — Rutherford class 112
6 months — Rutherford class 28
6 months — Rutherford class 35
6 months — Rutherford class 40
12 months — Rutherford class 08
12 months — Rutherford class 111
12 months — Rutherford class 26
12 months — Rutherford class 34
12 months — Rutherford class 40
SecondaryChange in Grade of Walking Impairment Questionnaire (WIQ) Post B-Laser™ Device Procedure Compared to Baseline

Change in Grade of Walking Impairment Questionnaire (WIQ) Post B-Laser™ Device Procedure Compared to Baseline. WIQ score ranges from 0-100 with higher score indicating a better walking outcomes. The change is calculated as the value at the later time point minus the value at the earlier time point, when positive results represent increases while negative results represent decrease, so higher WIQ score at the later time point represents an improvement through time and vice versa.

Time frame:
baseline and 30 days, 6 months and 12 months post procedure
Reported as:
Mean · score on a scale
Change in Grade of Walking Impairment Questionnaire (WIQ) Post B-Laser™ Device Procedure Compared to Baseline
score on a scaleB-Laser™ Atherectomy Catheter
baseline34.16 ± 8.15
30 days71.72 ± 19.88
6 months67.84 ± 22.05
12 months53.30 ± 18.09
Post-hocNumber of Lesions With Post-intervention Residual Diameter Stenosis of ≤30% With Adjunctive Therapy Assessed by Fluoroscopic Angiography in Cases Where Adjunctive Therapy is Medically Applicable

EX-PAD-01 study secondary efficacy endpoint of the post adjunctive therapy residual diameter stenosis, was set per protocol with a threshold at \<30%, however, in many other atherectomy studies, this threshold is set at ≤30%, Therefore results with this threshold are presented as well

Time frame:
Intraoperative (at the end of the index procedure, after the last adjunctive therapy, e.g. last balloon or last stent)
Reported as:
Count of units · lesions
Number of Lesions With Post-intervention Residual Diameter Stenosis of ≤30% With Adjunctive Therapy Assessed by Fluoroscopic Angiography in Cases Where Adjunctive Therapy is Medically Applicable
lesionsB-Laser™ Atherectomy Catheter
Number of Lesions With Post-intervention Residual Diameter Stenosis of ≤30% With Adjunctive Therapy Assessed by Fluoroscopic Angiography in Cases Where Adjunctive Therapy is Medically Applicable48

Adverse events

Collected over 30 days, 6 months and 12 months post procedure with B-Laser™ device. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
B-Laser™ Atherectomy Catheter0/46 (0%)14/46 (30.4%)15/46 (32.6%)
Most frequent serious events
Showing 10 of 15
Most frequent serious events
EventB-Laser™ Atherectomy Catheter
Heart FailureCardiac disorders2/46
Vascular access site hematomaInjury, poisoning and procedural complications2/46
Superficial femoral arterial stenosis & Claudication@Leg ischemia@Disease progressionVascular disorders2/46
Angina PectorisCardiac disorders1/46
Chronic ischemic heart disease, unspecifiedCardiac disorders1/46
Non STEMI@Atrioventricular block@Cardiogenic shock@Acute renal failureCardiac disorders1/46
Rectal hemorrhageGastrointestinal disorders1/46
Large intestine angiodysplasiaGastrointestinal disorders1/46
Upper gastrointestinal hemorrhage@ Esophagitis@ Gastroesophageal reflux diseaseGastrointestinal disorders1/46
Leg ischemia@Superficial femoral arterial stenosis@ClaudicationVascular disorders1/46
Most frequent other events
Most frequent other events
EventB-Laser™ Atherectomy Catheter
Leg ischemia@Superficial femoral arterial stenosisVascular disorders4/46
Vascular dissectionVascular disorders3/46
Edema lower limbGeneral disorders2/46
Arterial occlusionVascular disorders1/46
PseudoaneurysmInjury, poisoning and procedural complications1/46
Leg ischemiaVascular disorders1/46
ClaudicationVascular disorders1/46
Nasal bleedingRespiratory, thoracic and mediastinal disorders1/46
HyperglycemiaMetabolism and nutrition disorders1/46
Skin infectionInfections and infestations1/46

Baseline characteristics

Age, Continuous
Age, Continuous(years)B-Laser™ Atherectomy Catheter
Mean64 ± 8.5
Sex: Female, Male
Sex: Female, Male(Participants)B-Laser™ Atherectomy Catheter
Female12
Male38
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)B-Laser™ Atherectomy Catheter
ABI (Ankle Brachial Index)
ABI (Ankle Brachial Index)(ratio)B-Laser™ Atherectomy Catheter
Mean0.57 ± 0.14
08

Study locations

2 sites
  • Gornoslaskie Centrum Medyczne im. prof. Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach
    Katowice, 40635, Poland
  • Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
    Poznan, 61848, Poland
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Nov 20, 2016

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02556255
Lead sponsor
Eximo Medical Ltd.
Collaborators
KCRI
Responsible party
Sponsor
First posted
Sep 22, 2015
Start date
Oct 2015
Primary completion
Aug 2017
Completion
Nov 20, 2020
Results posted
Feb 21, 2019
Last update
Mar 3, 2021

Study contacts

Oshrat Cohen, Ph.D., MBA
study director · Angiodynamics, Inc.
Waclaw Kuczmik, Dr.
principal investigator · Górnośląskie Centrum Medyczne im. prof. Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach
Grzegorz Oszkinis, Prof.
principal investigator · Poznan Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im.Karola Marcinkowskiego
Lukasz Dzieciuchowicz, Prof
principal investigator · Poznan Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im.Karola Marcinkowskiego
Lukasz Kruszyna, Prof
principal investigator · Poznan Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im.Karola Marcinkowskiego

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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