N/A Completed N=97 Treatment

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

PAD

Source: ClinicalTrials.gov NCT03157531 ↗

Enrolled (actual)

Serious AEs

46.2%

Results posted

Jun 2019

Primary outcomePrimary: Acute Technical Success — 33.6 Change in RDS (%)

Summary

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Acute Technical Success	33.6	—
PRIMARY Number of Participants With Freedom From 30 Days Major Adverse Events (MAEs)	92	—
SECONDARY Number of Lesions With Freedom From Clinically Significant [1] Device Related Adverse Events (AEs) Requiring Intervention in the Target Vessel	107	—
SECONDARY Number of Lesions With Freedom From Non-Clinically Significant [1] Device Related Adverse Events (AEs) in the Target Vessel	91	—
SECONDARY Number of Lesions With Residual Stenosis by Angiography of ≤ 30% Post-procedure Including Any Adjunctive Therapy, With no Flow Limiting Dissection.	95; 12	—
SECONDARY PAD Measurements at the 30-day Visit Post-procedure Compared to Baseline (1)	-1.79; 0.26	—
SECONDARY PAD Measurements at the 30-day Visit Post-procedure Compared to Baseline (2)	0.24	—
SECONDARY Number of Lesions With Clinical Success at 30 Days	90	—

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

Target lesion is in a vessel graft or synthetic graft.
Target lesion length 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 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™.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03157531). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.