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

Completed · Not applicable

Conditions studied: PAD

In brief

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

Key facts

Study ID

NCT03157531

Run by

Eximo Medical Ltd.

People needed

97

Starts

2017-09-06

Expected to finish

2018-10-11

Last updated by the study team

2019-06-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is ≥ 18 years old.
• Subject is a candidate for atherectomy for infrainguinal peripheral artery disease.
• Documented symptomatic atherosclerotic peripheral artery disease Rutherford Classification 2-4.
• 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.
• Subject is capable and willing to comply with the scheduled follow up
• Subject or appropriate legal surrogate is able and willing to sign a written Informed Consent Form (ICF).
• Intraoperative inclusion criteria (by fluoroscopy angiogram):
• Target lesion has a stenosis estimated to be ≥70%.
• In ATK subjects - at least one patent tibial run-off vessel into the foot

You may not qualify if…

• Target lesion is in a vessel graft or synthetic graft.
• Target lesion length <1cm and >15 cm (in ISR cases could be >25cm).
• 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.
• Intent to use other atherectomy device in the same procedure.
• 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) or inability to tolerate antiplatelet medication(s), anticoagulation, or thrombolytic therapy.
• Subjects requiring dialysis.
• Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
• Serious illness that may affect subject compliance to protocol and 30-day follow-up.
• Participating in another clinical study
• Subject is pregnant or planning to become pregnant during the study period.
• Life expectancy < 12 months
• Any planned amputation above the ankle.
• Intraoperative exclusion criteria (by fluoroscopy angiogram):
• Inability to intraluminally cross and secure a 0.014" wire across the target lesion.
• Target lesion length <1cm and >15 cm (in ISR cases >25cm).
• Reference vessel lumen diameter proximal to target lesion is <150% of the outer diameter of the B-LaserTM.
• Any clinical and/or angiographic complication prior to the planed insertion of B-laser™.

Where it is running

• Arkansas Heart — Little Rock, Arkansas, United States
• Orlando Health — Altamonte Springs, Florida, United States
• Cardiovascular solutions institute, Blake MC — Bradenton, Florida, United States
• North Florida Regional Medical Center — Gainesville, Florida, United States
• UnityPoint Trinity Bettendorf , Genesis Health System — Davenport, Iowa, United States
• St. Louis Heart and Vascular — St Louis, Missouri, United States
• Holy Name Medical Center — Teaneck, New Jersey, United States
• Wellmont CVA Heart Institute — Kingsport, Tennessee, United States
• Medical University Graz — Graz, Austria
• Policlinico Abano Terme — Abano Terme, Italy
• Maria Cecilia Hospital — Cotignola, Italy

Full record on ClinicalTrials.gov

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