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Peripheral Arterial DiseaseNCT02556255

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

A study testing B-Laser™ Atherectomy Catheter in people with Peripheral Arterial Disease, run by Eximo Medical Ltd. at 2 sites in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral Arterial Disease
What is being tested?
B-Laser™ Atherectomy Catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
2 sitesPoland
Study dates
Oct 2015to 20 Nov 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject is ≥ 18 years old.
  • Subject is a candidate for endovascular intervention for peripheral artery disease in the lower extremities.
  • Documented symptomatic atherosclerotic peripheral artery disease Rutherford Classification 2-4.
  • 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.
  • At least one patent tibial run-off vessel at baseline.
  • Subject is capable and willing to comply with the scheduled follow up.
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  • Subject is able and willing to sign a written informed consent form (ICF).
  • Intraoperative inclusion criteria (by fluoroscopy angiogram):
  • Reference vessel lumen diameter proximal to target lesion is ≥150% of the outer diameter of the B-Laser™ to be used.
  • Target lesion has been crossed with a guidewire within the true lumen.
  • Target lesion has a stenosis estimated to be ≥70%.

Who cannot join

  • Target lesion is in a vessel graft or synthetic graft.
  • Target lesion length >25 cm.
  • 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.
  • Intent to use other atherectomy device in the same procedure.
  • Flow limiting dissection proximal to, distal to or in the target lesion.
  • Evidence or history of intracranial or gastrointestinal bleeding, intracranial aneurysm, myocardial infarction or stroke within the past 2 months.
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  • 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).
  • Significant acute or chronic kidney disease with a creatinine level >2.5 mg/dl, and/or requiring dialysis.
  • Any thrombolytic therapy within 2 weeks of the index procedure.
  • History of severe trauma, fracture, major surgery or biopsy of a parenchymal organ within the past 14 days.
  • Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
  • Subjects in whom anti-platelet, anticoagulant, or thrombolytic therapy is contraindicated.
  • Serious illness that may affect subject compliance to protocol and at a minimum the 30-day follow-up.
  • Participating in other clinical study that involves any kind of intervention, including pharmaceutical.
  • Issue that in the judgment of the investigator, may affect the results of the study.
  • Subject is pregnant or planning to become pregnant during the study period.
  • Intraoperative exclusion criteria (by fluoroscopy angiogram):
  • Total occlusion of the Target lesion that cannot be crossed in the true lumen by 0.014" GW.
  • Target lesion length >25 cm.
  • Reference vessel lumen diameter proximal to target lesion is <150% of the outer diameter of the B-Laser™.
  • Any clinical and/or angiographic complication attributed to the use of another device prior to the study procedure.
  • Flow limiting dissection proximal, distal or in the target lesion.

Trial locations and contacts

2 sites in 1 country.

Poland2 sites

  • Gornoslaskie Centrum Medyczne im. prof. Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach

    Katowice, 40635

  • Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

    Poznan, 61848

Other trials in Poland

About this study

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

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.

Being tested
B-Laser™ Atherectomy Catheter
Keywords
Peripheral Arterial Disease, Peripheral Artery Disease, PAD, Atherosclerosis, Arterial Occlusive Diseases, Peripheral Vascular Diseases, PVD
Medical subject headings
Peripheral Arterial Disease, Atherosclerosis, Arterial Occlusive Diseases, Peripheral Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • B-Laser™ Atherectomy CatheterDevice

    Laser atherectomy catheter based on 355 nm

Study groups in NCT02556255
Study groupRoleWhat they receive
B-Laser™ Atherectomy CatheterExperimentalPercutaneous 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™.
Receives: Device: B-Laser™ Atherectomy Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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

    Measured: 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

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

Secondary outcomes (6)

  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

    Measured: 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

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: baseline and 30 days, 6 months and 12 months post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionAug 2017
  4. Study completion20 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02556255
Sponsor's protocol ID
EX-PAD-01
Status last verified
Feb 2019
First submitted
2 Sep 2015
Last updated
3 Mar 2021
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing B-Laser™ Atherectomy Catheter in people with Peripheral Arterial Disease, run by Eximo Medical Ltd. at 2 sites in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With 30 Day Freedom From Major Adverse Events (time frame: 30 days post procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02556255.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.

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