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

Eximo Medical

Status: Completed

Conditions: PAD

Treatments: Device: B-Laser™ Atherectomy System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03157531

EX-PAD-03

Details and patient eligibility

About

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

Full description

The aim of the study is to assess the safety and efficacy of the Eximo Medical's B-Laser™ Atherectomy catheter in subjects with infrainguinal Peripheral Artery Disease (PAD).

Enrollment: 97 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject is ≥ 18 years old.
2. Subject is a candidate for atherectomy for infrainguinal peripheral artery disease.
3. Documented symptomatic atherosclerotic peripheral artery disease Rutherford Classification 2-4.
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.
5. Subject is capable and willing to comply with the scheduled follow up
6. Subject or appropriate legal surrogate is able and willing to sign a written Informed Consent Form (ICF).

Intraoperative inclusion criteria (by fluoroscopy angiogram):

1. Target lesion has a stenosis estimated to be ≥70%.

2. In ATK subjects - at least one patent tibial run-off vessel into the foot

Exclusion criteria

1. Target lesion is in a vessel graft or synthetic graft.
2. Target lesion length <1cm and >15 cm (in ISR cases could be >25cm).
3. 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.
4. Intent to use other atherectomy device in the same procedure.
5. Evidence or history of intracranial or gastrointestinal bleeding, intracranial aneurysm, myocardial infarction or stroke within the past 2 months.
6. Evidence or history of aneurysm in the target vessel within the past 2 months.
7. History of bleeding diathesis, coagulopathy or inability to accept blood transfusions.
8. History of heparin-induced thrombocytopenia (HIT) or inability to tolerate antiplatelet medication(s), anticoagulation, or thrombolytic therapy.
9. Subjects requiring dialysis.
10. Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
11. Serious illness that may affect subject compliance to protocol and 30-day follow-up.
12. Participating in another clinical study
13. Subject is pregnant or planning to become pregnant during the study period.
14. Life expectancy < 12 months
15. Any planned amputation above the ankle.

Intraoperative exclusion criteria (by fluoroscopy angiogram):

1. Inability to intraluminally cross and secure a 0.014" wire across the target lesion.

2. Target lesion length <1cm and >15 cm (in ISR cases >25cm).

3. Reference vessel lumen diameter proximal to target lesion is <150% of the outer diameter of the B-LaserTM.

4. Any clinical and/or angiographic complication prior to the planed insertion of B-laser™.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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97 participants in 1 patient group

B-Laser™ Atherectomy System

Experimental group

Description:

B-Laser™ Atherectomy System

Treatment:

Device: B-Laser™ Atherectomy System