Clinical trial NCT03157531: Safety and Effectiveness of B-Laser™ in Subjects Affected With Infrainguinal PAD
Official title: Safety and Effectiveness Evaluation of Eximo Medical's B-Laser™ Atherectomy Device, in Subjects Affected With Infrainguinal PAD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PAD
Lead sponsor: Eximo Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2017-05-17
Enrollment: 97
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: This is a prospective, single-arm, multi-center, international, open-label, clinical study.

Detailed 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).

Eligibility criteria: 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

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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™.

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Primary outcomes:
measure: Acute Technical Success
timeFrame: Perioperative
measure: Number of Participants With Freedom From 30 Days Major Adverse Events (MAEs)
timeFrame: 30 (+/-5) days post procedure
Secondary outcomes:
measure: Number of Lesions With Freedom From Clinically Significant [1] Device Related Adverse Events (AEs) Requiring Intervention in the Target Vessel
timeFrame: Perioperative and up to 30 (+/-5) days post procedure
measure: Number of Lesions With Freedom From Non-Clinically Significant [1] Device Related Adverse Events (AEs) in the Target Vessel
timeFrame: Perioperative and up to 30 (+/-5) days post procedure
measure: Number of Lesions With Residual Stenosis by Angiography of ≤ 30% Post-procedure Including Any Adjunctive Therapy, With no Flow Limiting Dissection.
timeFrame: Perioperative
measure: PAD Measurements at the 30-day Visit Post-procedure Compared to Baseline (1)
timeFrame: 30 (+/-5) days post procedure
measure: PAD Measurements at the 30-day Visit Post-procedure Compared to Baseline (2)
timeFrame: 30 (+/-5) days post procedure
measure: Number of Lesions With Clinical Success at 30 Days
timeFrame: 30 (+/-5) days post procedure
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Heart
state: Arkansas
city: Altamonte Springs
country: United States
facility: Orlando Health
state: Florida
city: Bradenton
country: United States
facility: Cardiovascular solutions institute, Blake MC
state: Florida
city: Gainesville
country: United States
facility: North Florida Regional Medical Center
state: Florida
city: Davenport
country: United States
facility: UnityPoint Trinity Bettendorf , Genesis Health System
state: Iowa
city: Saint Louis
country: United States
facility: St. Louis Heart and Vascular
state: Missouri
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: Kingsport
country: United States
facility: Wellmont CVA Heart Institute
state: Tennessee
city: Graz
country: Austria
facility: Medical University Graz
city: Abano Terme
country: Italy
facility: Policlinico Abano Terme
city: Cotignola
country: Italy
facility: Maria Cecilia Hospital
Study officials:
affiliation: Holy Name Medical Center, Teaneck, New Jersey, United States, 07666
name: John Rundback, Dr.
role: PRINCIPAL_INVESTIGATOR
References: