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

NCT02556255 | Completed Results

• 1 other identifier: EX-PAD-01
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 2

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.

Conditions

Peripheral Arterial Disease

Keywords

Peripheral Arterial Disease; Peripheral Artery Disease; PAD; Atherosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; PVD

Outcome Measures

Primary Outcomes (3)

• 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

  30 days post procedure

• 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

  Perioperative (until discharge), an average of 6 days

• 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

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

Secondary Outcomes (6)

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

  Perioperative (until discharge), an average of 6 days

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

  30 days post procedure

• 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

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

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

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

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

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

Study Arms (1)

B-Laser™ Atherectomy Catheter

EXPERIMENTAL

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

B-Laser™ Atherectomy Catheter DEVICE

Laser atherectomy catheter based on 355 nm

B-Laser™ Atherectomy Catheter

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 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.
• Subject is able and willing to sign a written informed consent form (ICF).
• 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%.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Eximo Medical Ltd.: lead
• KCRI: collaborator

Study Sites (2)

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

Katowice, 40635, Poland

Location

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

Poznan, 61848, Poland

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Atherosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Arteriosclerosis; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Oshrat Cohen
• Organization: Eximo Medical

oshratc@eximomedical.com

97286307639

Study Officials

• Oshrat Cohen, Ph.D., MBA

  Angiodynamics, Inc.

  STUDY DIRECTOR

• Waclaw Kuczmik, Dr.

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

  PRINCIPAL INVESTIGATOR

• Grzegorz Oszkinis, Prof.

  Poznan Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im.Karola Marcinkowskiego

  PRINCIPAL INVESTIGATOR

• Lukasz Dzieciuchowicz, Prof

  Poznan Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im.Karola Marcinkowskiego

  PRINCIPAL INVESTIGATOR

• Lukasz Kruszyna, Prof

  Poznan Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im.Karola Marcinkowskiego

  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: September 2, 2015
• First Posted: September 22, 2015
• Study Start: October 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: November 20, 2020
• Last Updated: March 3, 2021
• Results First Posted: February 21, 2019

Record last verified: 2019-02

Locations

PL (2)