18 and older, any sex, with PAD. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Acute Technical SuccessPrimary· Perioperative
Reduction from baseline in residual diameter stenosis (%), prior to any adjunctive therapy, achieved by the B-Laser™ catheter
A change (always a reduction) between two time points (baseline time-point and post B-Laser treatment time-point, both perioperative) is reported:
* As assessed quantitatively by the core laboratory.
* This endpoint will be met if the mean reduction in residual diameter stenosis is greater than 20%.
* A greater reduction means better results.
Group
Value
95% CI
B-Laser™ Atherectomy System
33.6
± 14.2
Number of Participants With Freedom From 30 Days Major Adverse Events (MAEs)Primary· 30 (+/-5) days post procedure
1. Unplanned target limb amputation above the ankle
2. Clinically Driven Target Lesion Revascularization (CDTLR)
3. Cardiovascular related deaths
* As adjudicated by the Clinical Event Committee (CEC).
* This endpoint will be met if the freedom from MAE rate is greater than 85%.
Group
Value
95% CI
B-Laser™ Atherectomy System
92
Number of Lesions With Freedom From Clinically Significant [1] Device Related Adverse Events (AEs) Requiring Intervention in the Target VesselSecondary· Perioperative and up to 30 (+/-5) days post procedure
1. Perforation
2. Dissection
3. Distal embolization or in situ thrombus
4. Pseudoaneurysm
* As adjudicated by the Clinical Event Committee (CEC). \[1\] Note: Clinically Significant AEs are defined as adverse events that REQUIRE any intervention,treatment or any hospitalization or its prolongation, in order to prevent death, persistent/significant disability/incapacity or congenital anomaly/birth defect.
Group
Value
95% CI
B-Laser™ Atherectomy System
107
Number of Lesions With Freedom From Non-Clinically Significant [1] Device Related Adverse Events (AEs) in the Target VesselSecondary· Perioperative and up to 30 (+/-5) days post procedure
1. Perforation
2. Dissection
3. Distal embolization or in situ thrombus
4. Pseudoaneurysm
* As adjudicated by the Clinical Event Committee (CEC). \[1\] Note: non-Clinically Significant AEs are defined as adverse events that DO NOT REQUIRE any intervention, treatment or any hospitalization or its prolongation, in order to prevent death, persistent/significant disability/incapacity or congenital anomaly/birth defect.
Group
Value
95% CI
B-Laser™ Atherectomy System
91
Number of Lesions With Residual Stenosis by Angiography of ≤ 30% Post-procedure Including Any Adjunctive Therapy, With no Flow Limiting Dissection.Secondary· Perioperative
Number of Lesions with residual stenosis by angiography of ≤ 30% post-procedure including any adjunctive therapy, with no flow limiting dissection.
\* As assessed quantitatively by the core laboratory.
Group
Value
95% CI
B-Laser™ Atherectomy System
95
B-Laser™ Atherectomy System
12
PAD Measurements at the 30-day Visit Post-procedure Compared to Baseline (1)Secondary· 30 (+/-5) days post procedure
1. Rutherford Classification: a doctor determined 7 stages scale (0= Asymptomatic, 6= Severe ischemic ulcers/frank gangrene) representing PAD progress, lower value = better outcome. Positive difference between time-points represents a clinical deterioration through time and vice versa.
2. Walking Impairment Questionnaire (WIQ): a patient fulfilled survey to grade physical ability representing PAD progress, has 3 sub-scales (walking speed, distance, climbing stairs), when the total score ranges between 0-100, higher value = better outcome. Positive difference between time-points represents a cl
Rutherford difference (30 day post-procedure - BL)
Group
Value
95% CI
B-Laser™ Atherectomy System
-1.79
± 1.22
WIQ difference (30 day post-procedure - BL)
Group
Value
95% CI
B-Laser™ Atherectomy System
0.26
± 0.28
PAD Measurements at the 30-day Visit Post-procedure Compared to Baseline (2)Secondary· 30 (+/-5) days post procedure
c) Ankle-Brachial Index (ABI): ankle/arm blood pressure ratio. Normal value ranges between 0.9-1.3. Under 0.9 index means blood has a difficult time getting to legs \& feet; 0.4-0.9 indicates mild-moderate PAD; 0.4 and lower indicates severe PAD. Positive difference between time-points represents a clinical improvement through time and vice versa.
Group
Value
95% CI
B-Laser™ Atherectomy System
0.24
± 0.18
Number of Lesions With Clinical Success at 30 DaysSecondary· 30 (+/-5) days post procedure
Defined as \< 50% stenosis at the treated lesion, as assessed quantitatively by duplex ultrasound when the peak systolic velocity ratio is \< 2.5.
\* As assessed quantitatively by the core laboratory.
Group
Value
95% CI
B-Laser™ Atherectomy System
90
Number of Participants With Freedom From 6 Months Major Adverse Events (MAEs) [Not a Study Pre-specified Endpoint]Secondary· 6 months (+/-14 days) post procedure
1. Unplanned target limb amputation above the ankle
2. Clinically Driven Target Lesion Revascularization (CDTLR)
3. Cardiovascular related deaths
* As adjudicated by the Clinical Event Committee (CEC).
Group
Value
95% CI
B-Laser™ Atherectomy System
86
PAD Measurements at the 6-month Visit Post-procedure Compared to Baseline [Not a Study Pre-specified Endpoint] (1)Secondary· 6-month (+/-14 days) post-procedure
1. Rutherford Classification: a doctor determined 7 stages scale (0= Asymptomatic, 6= Severe ischemic ulcers/frank gangrene) representing PAD progress, lower value = better outcome. Positive difference between time-points represents a clinical deterioration through time and vice versa.
2. Walking Impairment Questionnaire (WIQ): a patient fulfilled survey to grade physical ability representing PAD progress, has 3 sub-scales (walking speed, distance, climbing stairs), when the total score ranges between 0-100, higher value = better outcome. Positive difference between time-points represents a cl
PAD Measurements at the 6-month Visit Post-procedure Compared to Baseline [Not a Study Pre-specified Endpoint] (2)Secondary· 6-month (+/-14 days) post-procedure
c) Ankle-Brachial Index (ABI): ankle/arm blood pressure ratio. Normal value ranges between 0.9-1.3. Under 0.9 index means blood has a difficult time getting to legs \& feet; 0.4-0.9 indicates mild-moderate PAD; 0.4 and lower indicates severe PAD. Positive difference between time-points represents a clinical improvement through time and vice versa.
Group
Value
95% CI
B-Laser™ Atherectomy System
0.17
± 0.28
Number of Lesions With 6-Month Patency [Not a Study Pre-specified Endpoint]Secondary· 6 months (+/-14 days) post procedure
Defined as \< 50% stenosis at the treated lesion, as assessed quantitatively by duplex ultrasound when the peak systolic velocity ratio is \< 2.5.
\* As assessed quantitatively by the core laboratory.
This is not a study pre-specified endpoint.
Group
Value
95% CI
B-Laser™ Atherectomy System
77
Adverse events — posted to ClinicalTrials.gov
Time frame: 6 months (+/-14 days) post procedure.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eximo Medical Ltd.
Last refreshed: 20 June 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03157531.