Clinical trial NCT02556255: Safety and Effectiveness Study of Eximo's B-Laser™ Atherectomy Device for PAD Treatment
Official title: Safety and Effectiveness Evaluation of Eximo's B-Laser™ Atherectomy Device, in Subjects Affected With PAD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Peripheral Arterial Disease
Peripheral Artery Disease
PAD
Atherosclerosis
Arterial Occlusive Diseases
Peripheral Vascular Diseases
PVD
Lead sponsor: Eximo Medical Ltd.
Sponsor class: INDUSTRY
Collaborators: name: KCRI
First posted: 2015-09-22
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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:

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.

Primary outcomes:
measure: Number of Participants With 30 Day Freedom From Major Adverse Events
timeFrame: 30 days post procedure
measure: Number of Participants With Perioperative (Until Discharge) Freedom From Device/Procedure* Related Adverse Events (1)
timeFrame: Perioperative (until discharge), an average of 6 days
measure: Number of Lesions With Technical Success Rate: the Ability of the B-Laser™ Catheter to Cross the Target Lesion Stenosis Over the Wire.
timeFrame: Intraoperative (during the index procedure, after B-Laser™ catheter crossing, before adjunctive therapy)
Secondary outcomes:
measure: Number of Participants With Perioperative (Until Discharge) Freedom From Device/Procedure* Related Adverse Events (2)
timeFrame: Perioperative (until discharge), an average of 6 days
measure: Number of Participants With 30 Day Freedom From Device/Procedure* Related Adverse Events
timeFrame: 30 days post procedure
measure: 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
timeFrame: Intraoperative (at the end of the index procedure, after the last adjunctive therapy, e.g. last balloon or last stent)
measure: Change in Ankle-Brachial Index (ABI) Post B-Laser™ Device Procedure Compared to Baseline
timeFrame: baseline and 30 days, 6 months and 12 months post procedure
measure: Change in Rutherford Classification Post B-Laser™ Device Procedure Compared to Baseline
timeFrame: baseline and 30 days, 6 months and 12 months post procedure
measure: Change in Grade of Walking Impairment Questionnaire (WIQ) Post B-Laser™ Device Procedure Compared to Baseline
timeFrame: baseline and 30 days, 6 months and 12 months post procedure
Other outcomes:
Locations:
city: Katowice
country: Poland
facility: Gornoslaskie Centrum Medyczne im. prof. Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach
city: Poznan
country: Poland
facility: Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Study officials:
affiliation: Angiodynamics, Inc.
name: Oshrat Cohen, Ph.D., MBA
role: STUDY_DIRECTOR
affiliation: Górnośląskie Centrum Medyczne im. prof. Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach
name: Waclaw Kuczmik, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Poznan Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im.Karola Marcinkowskiego
name: Grzegorz Oszkinis, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Poznan Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im.Karola Marcinkowskiego
name: Lukasz Dzieciuchowicz, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Poznan Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im.Karola Marcinkowskiego
name: Lukasz Kruszyna, Prof
role: PRINCIPAL_INVESTIGATOR
References: