Trial Outcomes & Findings for Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease (NCT NCT04229563)
NCT ID: NCT04229563
Last Updated: 2026-05-18
Results Overview
Percentage of lesions with successful revascularization of target vessel defined as ≤30% residual stenosis at the treated lesion post Auryon atherectomy and final adjunctive treatment (if required), as evaluated by angiographic corelab.
Recruitment status
COMPLETED
Target enrollment
102 participants
Primary outcome timeframe
Peri-procedural (by the end of the index procedure)
Results posted on
2026-05-18
Participant Flow
Participant milestones
| Measure |
Study Patients
Eligible PAD patients who are routinely treated with atherectomy by AURYON™ Atherectomy System.
AURYON™ Atherectomy System: The AURYON™ System consists of two sub-units: 1) a single use catheter ("AURYON™ catheter"); and 2) a laser system.
The Auryon Atherectomy System and Auryon Atherectomy Catheters with aspiration are indicated for use as atherectomy devices for arterial stenoses, including in-stent restenosis (ISR), and to aspirate thrombus adjacent to stenoses in native and stented infra-inguinal arteries.
The Auryon Atherectomy System and Auryon Atherectomy Catheters without aspiration are indicated for use in the treatment, including atherectomy, of infra-inguinal stenoses and occlusions.
|
|---|---|
|
Overall Study
STARTED
|
102
|
|
Overall Study
COMPLETED
|
68
|
|
Overall Study
NOT COMPLETED
|
34
|
Reasons for withdrawal
| Measure |
Study Patients
Eligible PAD patients who are routinely treated with atherectomy by AURYON™ Atherectomy System.
AURYON™ Atherectomy System: The AURYON™ System consists of two sub-units: 1) a single use catheter ("AURYON™ catheter"); and 2) a laser system.
The Auryon Atherectomy System and Auryon Atherectomy Catheters with aspiration are indicated for use as atherectomy devices for arterial stenoses, including in-stent restenosis (ISR), and to aspirate thrombus adjacent to stenoses in native and stented infra-inguinal arteries.
The Auryon Atherectomy System and Auryon Atherectomy Catheters without aspiration are indicated for use in the treatment, including atherectomy, of infra-inguinal stenoses and occlusions.
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|---|---|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Death
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1
|
|
Overall Study
Lost to Follow-up
|
14
|
|
Overall Study
Withdrawal by Subject
|
12
|
Baseline Characteristics
Unavailable data for 1 participant out of the 102
Baseline characteristics by cohort
| Measure |
Study Patients
n=107 Lesions
Eligible PAD patients who are routinely treated with atherectomy by AURYON™ Atherectomy System.
AURYON™ Atherectomy System: The AURYON™ System consists of two sub-units: 1) a single use catheter ("AURYON™ catheter"); and 2) a laser system.
The Auryon Atherectomy System and Auryon Atherectomy Catheters with aspiration are indicated for use as atherectomy devices for arterial stenoses, including in-stent restenosis (ISR), and to aspirate thrombus adjacent to stenoses in native and stented infra-inguinal arteries.
The Auryon Atherectomy System and Auryon Atherectomy Catheters without aspiration are indicated for use in the treatment, including atherectomy, of infra-inguinal stenoses and occlusions.
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|---|---|
|
Age, Continuous
|
68.4 years
STANDARD_DEVIATION 10.2 • n=102 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=102 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=102 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=102 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=102 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=102 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=102 Participants
|
|
Race (NIH/OMB)
White
|
73 Participants
n=102 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=102 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=102 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=102 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
65 Participants
n=102 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=102 Participants
|
|
Region of Enrollment
United States
|
102 participants
n=102 Participants
|
|
Rutherford Category at baseline
|
3.64 units on a scale
STANDARD_DEVIATION 0.92 • n=101 Participants • Unavailable data for 1 participant out of the 102
|
|
WIQ (Walking Impairment Questionnaire) at baseline
|
22.77 units on a scale
STANDARD_DEVIATION 22.52 • n=95 Participants • Unavailable data for 7 participants out of the 102
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|
ABI/TBI (Ankle/Toe Brachial Index) at baseline
|
0.73 Ratio
STANDARD_DEVIATION 0.28 • n=68 Participants • Unavailable data for 34 participants out of the 102.
|
|
Baseline % Stenosis of the target lesion (by Core laboratory)
|
87.10 Percentage of Stenosis
STANDARD_DEVIATION 16.58 • n=107 Lesions • Multiple lesions treated per patient
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|
Baseline Calcification level at target lesion (core lab adjudicated)
0 - None
|
31 Lesions
n=107 Lesions
|
|
Baseline Calcification level at target lesion (core lab adjudicated)
1 - Focal
|
4 Lesions
n=107 Lesions
|
|
Baseline Calcification level at target lesion (core lab adjudicated)
2 - Mild
|
19 Lesions
n=107 Lesions
|
|
Baseline Calcification level at target lesion (core lab adjudicated)
3 - Moderate
|
22 Lesions
n=107 Lesions
|
|
Baseline Calcification level at target lesion (core lab adjudicated)
4 - Severe
|
17 Lesions
n=107 Lesions
|
|
Baseline Calcification level at target lesion (core lab adjudicated)
Unknown
|
14 Lesions
n=107 Lesions
|
|
Target lesion length (by Core laboratory)
|
13.6 Centimeter (cm)
n=107 Lesions
|
PRIMARY outcome
Timeframe: Peri-procedural (by the end of the index procedure)Population: Angiography Core Lab-reported findings of Post Final Treatment (355 nm laser Target Lesion only). N=100 lesions in 88 subjects with available core lab stenosis post-final treatment.
Percentage of lesions with successful revascularization of target vessel defined as ≤30% residual stenosis at the treated lesion post Auryon atherectomy and final adjunctive treatment (if required), as evaluated by angiographic corelab.
Outcome measures
| Measure |
Study Patients
n=100 Lesions
Eligible Peripheral Artery Disease (PAD) patients who are routinely treated with atherectomy by AURYON™ Atherectomy System.
AURYON™ Atherectomy System: The AURYON™ System consists of two sub-units: 1) a single use catheter ("AURYON™ catheter"); and 2) a laser system.
The Auryon Atherectomy System and Auryon Atherectomy Catheters with aspiration are indicated for use as atherectomy devices for arterial stenoses, including in-stent restenosis (ISR), and to aspirate thrombus adjacent to stenoses in native and stented infra-inguinal arteries.
The Auryon Atherectomy System and Auryon Atherectomy Catheters without aspiration are indicated for use in the treatment, including atherectomy, of infra-inguinal stenoses and occlusions.
|
6 Months MAEs
Major Adverse Events (MAEs) over Time (Cumulative) - ITT population
1. Major adverse event (MAE) includes unplanned target limb amputation, cardiovascular death, clinically driven target lesion revascularization (CD-TLR), and target vessel revascularization (TVR).
2. Events are cumulative through time; events occurring up to the upper bound of the visit windows are considered; subjects are accountable if they were still monitored at the lower bound of the visit window. Thus, the time intervals are:
* 6 Months: events from Day 0 to Day 213
|
12 Months MAEs
Major Adverse Events (MAEs) over Time (Cumulative) - ITT population
1. Major adverse event (MAE) includes unplanned target limb amputation, cardiovascular death, clinically driven target lesion revascularization (CD-TLR), and target vessel revascularization (TVR).
2. Events are cumulative through time; events occurring up to the upper bound of the visit windows are considered; subjects are accountable if they were still monitored at the lower bound of the visit window. Thus, the time intervals are:
* 12 Months: events from Day 0 to Day 395
|
24 Months MAEs
Major Adverse Events (MAEs) over Time (Cumulative) - ITT population
1. Major adverse event (MAE) includes unplanned target limb amputation, cardiovascular death, clinically driven target lesion revascularization (CD-TLR), and target vessel revascularization (TVR).
2. Events are cumulative through time; events occurring up to the upper bound of the visit windows are considered; subjects are accountable if they were still monitored at the lower bound of the visit window. Thus, the time intervals are:
* 24 Months: events from Day 0 to completion of study
|
|---|---|---|---|---|
|
Primary Efficacy: Acute Procedural Success
|
69 Lesions
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Through discharge, an average of 5 daysPercentage of subjects with freedom from peri-procedural major adverse events (PPMAE), defined as (a) flow-limiting dissection, (b) clinically significant distal embolization, (c) bailout stenting, (d) major/unplanned amputation, (e) target vessel perforation requiring endovascular or surgical repair or (f) death, till discharge.
Outcome measures
| Measure |
Study Patients
n=102 Participants
Eligible Peripheral Artery Disease (PAD) patients who are routinely treated with atherectomy by AURYON™ Atherectomy System.
AURYON™ Atherectomy System: The AURYON™ System consists of two sub-units: 1) a single use catheter ("AURYON™ catheter"); and 2) a laser system.
The Auryon Atherectomy System and Auryon Atherectomy Catheters with aspiration are indicated for use as atherectomy devices for arterial stenoses, including in-stent restenosis (ISR), and to aspirate thrombus adjacent to stenoses in native and stented infra-inguinal arteries.
The Auryon Atherectomy System and Auryon Atherectomy Catheters without aspiration are indicated for use in the treatment, including atherectomy, of infra-inguinal stenoses and occlusions.
|
6 Months MAEs
Major Adverse Events (MAEs) over Time (Cumulative) - ITT population
1. Major adverse event (MAE) includes unplanned target limb amputation, cardiovascular death, clinically driven target lesion revascularization (CD-TLR), and target vessel revascularization (TVR).
2. Events are cumulative through time; events occurring up to the upper bound of the visit windows are considered; subjects are accountable if they were still monitored at the lower bound of the visit window. Thus, the time intervals are:
* 6 Months: events from Day 0 to Day 213
|
12 Months MAEs
Major Adverse Events (MAEs) over Time (Cumulative) - ITT population
1. Major adverse event (MAE) includes unplanned target limb amputation, cardiovascular death, clinically driven target lesion revascularization (CD-TLR), and target vessel revascularization (TVR).
2. Events are cumulative through time; events occurring up to the upper bound of the visit windows are considered; subjects are accountable if they were still monitored at the lower bound of the visit window. Thus, the time intervals are:
* 12 Months: events from Day 0 to Day 395
|
24 Months MAEs
Major Adverse Events (MAEs) over Time (Cumulative) - ITT population
1. Major adverse event (MAE) includes unplanned target limb amputation, cardiovascular death, clinically driven target lesion revascularization (CD-TLR), and target vessel revascularization (TVR).
2. Events are cumulative through time; events occurring up to the upper bound of the visit windows are considered; subjects are accountable if they were still monitored at the lower bound of the visit window. Thus, the time intervals are:
* 24 Months: events from Day 0 to completion of study
|
|---|---|---|---|---|
|
Primary Safety: Freedom From Peri-procedural Major Adverse Events (PPMAE)
|
97 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Till discharge, an average of 5 daysNumber of participants with device related complications requiring intervention, defined as peri procedural Major Adverse Events (MAEs), reported by the operating physician as caused directly due to the use of the AURYON device.
Outcome measures
| Measure |
Study Patients
n=102 Participants
Eligible Peripheral Artery Disease (PAD) patients who are routinely treated with atherectomy by AURYON™ Atherectomy System.
AURYON™ Atherectomy System: The AURYON™ System consists of two sub-units: 1) a single use catheter ("AURYON™ catheter"); and 2) a laser system.
The Auryon Atherectomy System and Auryon Atherectomy Catheters with aspiration are indicated for use as atherectomy devices for arterial stenoses, including in-stent restenosis (ISR), and to aspirate thrombus adjacent to stenoses in native and stented infra-inguinal arteries.
The Auryon Atherectomy System and Auryon Atherectomy Catheters without aspiration are indicated for use in the treatment, including atherectomy, of infra-inguinal stenoses and occlusions.
|
6 Months MAEs
Major Adverse Events (MAEs) over Time (Cumulative) - ITT population
1. Major adverse event (MAE) includes unplanned target limb amputation, cardiovascular death, clinically driven target lesion revascularization (CD-TLR), and target vessel revascularization (TVR).
2. Events are cumulative through time; events occurring up to the upper bound of the visit windows are considered; subjects are accountable if they were still monitored at the lower bound of the visit window. Thus, the time intervals are:
* 6 Months: events from Day 0 to Day 213
|
12 Months MAEs
Major Adverse Events (MAEs) over Time (Cumulative) - ITT population
1. Major adverse event (MAE) includes unplanned target limb amputation, cardiovascular death, clinically driven target lesion revascularization (CD-TLR), and target vessel revascularization (TVR).
2. Events are cumulative through time; events occurring up to the upper bound of the visit windows are considered; subjects are accountable if they were still monitored at the lower bound of the visit window. Thus, the time intervals are:
* 12 Months: events from Day 0 to Day 395
|
24 Months MAEs
Major Adverse Events (MAEs) over Time (Cumulative) - ITT population
1. Major adverse event (MAE) includes unplanned target limb amputation, cardiovascular death, clinically driven target lesion revascularization (CD-TLR), and target vessel revascularization (TVR).
2. Events are cumulative through time; events occurring up to the upper bound of the visit windows are considered; subjects are accountable if they were still monitored at the lower bound of the visit window. Thus, the time intervals are:
* 24 Months: events from Day 0 to completion of study
|
|---|---|---|---|---|
|
Number of Participants With Device Related Complications Requiring Intervention
|
5 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Post-discharge (at 30-days, 6-, 12-, and 24-months)Number of participants with post-discharge MAEs over time; defined as: (a) Unplanned target limb amputation, (b) cardiovascular death, (c) clinically driven target lesion revascularization, (d) target vessel revascularization (TVR).
Outcome measures
| Measure |
Study Patients
n=99 Participants
Eligible Peripheral Artery Disease (PAD) patients who are routinely treated with atherectomy by AURYON™ Atherectomy System.
AURYON™ Atherectomy System: The AURYON™ System consists of two sub-units: 1) a single use catheter ("AURYON™ catheter"); and 2) a laser system.
The Auryon Atherectomy System and Auryon Atherectomy Catheters with aspiration are indicated for use as atherectomy devices for arterial stenoses, including in-stent restenosis (ISR), and to aspirate thrombus adjacent to stenoses in native and stented infra-inguinal arteries.
The Auryon Atherectomy System and Auryon Atherectomy Catheters without aspiration are indicated for use in the treatment, including atherectomy, of infra-inguinal stenoses and occlusions.
|
6 Months MAEs
n=87 Participants
Major Adverse Events (MAEs) over Time (Cumulative) - ITT population
1. Major adverse event (MAE) includes unplanned target limb amputation, cardiovascular death, clinically driven target lesion revascularization (CD-TLR), and target vessel revascularization (TVR).
2. Events are cumulative through time; events occurring up to the upper bound of the visit windows are considered; subjects are accountable if they were still monitored at the lower bound of the visit window. Thus, the time intervals are:
* 6 Months: events from Day 0 to Day 213
|
12 Months MAEs
n=89 Participants
Major Adverse Events (MAEs) over Time (Cumulative) - ITT population
1. Major adverse event (MAE) includes unplanned target limb amputation, cardiovascular death, clinically driven target lesion revascularization (CD-TLR), and target vessel revascularization (TVR).
2. Events are cumulative through time; events occurring up to the upper bound of the visit windows are considered; subjects are accountable if they were still monitored at the lower bound of the visit window. Thus, the time intervals are:
* 12 Months: events from Day 0 to Day 395
|
24 Months MAEs
n=70 Participants
Major Adverse Events (MAEs) over Time (Cumulative) - ITT population
1. Major adverse event (MAE) includes unplanned target limb amputation, cardiovascular death, clinically driven target lesion revascularization (CD-TLR), and target vessel revascularization (TVR).
2. Events are cumulative through time; events occurring up to the upper bound of the visit windows are considered; subjects are accountable if they were still monitored at the lower bound of the visit window. Thus, the time intervals are:
* 24 Months: events from Day 0 to completion of study
|
|---|---|---|---|---|
|
Number of Participants With Major Adverse Events (MAEs) Over Time
|
3 Participants
|
9 Participants
|
10 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Post-discharge (at 6-, 12-, and 24-months)Population: Number of lesions with DUS patency measured at each follow-up timepoint.
Number of patent lesions, defined as \<50% stenosis at the treated lesion, with peak systolic velocity ratio (PSVR) of \<2.5, as assessed quantitatively by Duplex ultrasonography (DUS), at 6, 12, and 24 months.
Outcome measures
| Measure |
Study Patients
n=69 Lesions
Eligible Peripheral Artery Disease (PAD) patients who are routinely treated with atherectomy by AURYON™ Atherectomy System.
AURYON™ Atherectomy System: The AURYON™ System consists of two sub-units: 1) a single use catheter ("AURYON™ catheter"); and 2) a laser system.
The Auryon Atherectomy System and Auryon Atherectomy Catheters with aspiration are indicated for use as atherectomy devices for arterial stenoses, including in-stent restenosis (ISR), and to aspirate thrombus adjacent to stenoses in native and stented infra-inguinal arteries.
The Auryon Atherectomy System and Auryon Atherectomy Catheters without aspiration are indicated for use in the treatment, including atherectomy, of infra-inguinal stenoses and occlusions.
|
6 Months MAEs
n=69 Lesions
Major Adverse Events (MAEs) over Time (Cumulative) - ITT population
1. Major adverse event (MAE) includes unplanned target limb amputation, cardiovascular death, clinically driven target lesion revascularization (CD-TLR), and target vessel revascularization (TVR).
2. Events are cumulative through time; events occurring up to the upper bound of the visit windows are considered; subjects are accountable if they were still monitored at the lower bound of the visit window. Thus, the time intervals are:
* 6 Months: events from Day 0 to Day 213
|
12 Months MAEs
n=52 Lesions
Major Adverse Events (MAEs) over Time (Cumulative) - ITT population
1. Major adverse event (MAE) includes unplanned target limb amputation, cardiovascular death, clinically driven target lesion revascularization (CD-TLR), and target vessel revascularization (TVR).
2. Events are cumulative through time; events occurring up to the upper bound of the visit windows are considered; subjects are accountable if they were still monitored at the lower bound of the visit window. Thus, the time intervals are:
* 12 Months: events from Day 0 to Day 395
|
24 Months MAEs
Major Adverse Events (MAEs) over Time (Cumulative) - ITT population
1. Major adverse event (MAE) includes unplanned target limb amputation, cardiovascular death, clinically driven target lesion revascularization (CD-TLR), and target vessel revascularization (TVR).
2. Events are cumulative through time; events occurring up to the upper bound of the visit windows are considered; subjects are accountable if they were still monitored at the lower bound of the visit window. Thus, the time intervals are:
* 24 Months: events from Day 0 to completion of study
|
|---|---|---|---|---|
|
Number of Patent Lesions
|
49 Lesions
|
48 Lesions
|
37 Lesions
|
—
|
SECONDARY outcome
Timeframe: Post-discharge (at 6-, 12-, and 24-months)Population: Below-the-knee lesions only, with DUS measured at each follow-up timepoint
Number of below-the-knee (BTK) lesions with freedom from occlusion (100% stenosis by DUS) combined with freedom from clinically-driven target lesion revascularization (CD-TLR)
Outcome measures
| Measure |
Study Patients
n=23 Lesions
Eligible Peripheral Artery Disease (PAD) patients who are routinely treated with atherectomy by AURYON™ Atherectomy System.
AURYON™ Atherectomy System: The AURYON™ System consists of two sub-units: 1) a single use catheter ("AURYON™ catheter"); and 2) a laser system.
The Auryon Atherectomy System and Auryon Atherectomy Catheters with aspiration are indicated for use as atherectomy devices for arterial stenoses, including in-stent restenosis (ISR), and to aspirate thrombus adjacent to stenoses in native and stented infra-inguinal arteries.
The Auryon Atherectomy System and Auryon Atherectomy Catheters without aspiration are indicated for use in the treatment, including atherectomy, of infra-inguinal stenoses and occlusions.
|
6 Months MAEs
n=23 Lesions
Major Adverse Events (MAEs) over Time (Cumulative) - ITT population
1. Major adverse event (MAE) includes unplanned target limb amputation, cardiovascular death, clinically driven target lesion revascularization (CD-TLR), and target vessel revascularization (TVR).
2. Events are cumulative through time; events occurring up to the upper bound of the visit windows are considered; subjects are accountable if they were still monitored at the lower bound of the visit window. Thus, the time intervals are:
* 6 Months: events from Day 0 to Day 213
|
12 Months MAEs
Major Adverse Events (MAEs) over Time (Cumulative) - ITT population
1. Major adverse event (MAE) includes unplanned target limb amputation, cardiovascular death, clinically driven target lesion revascularization (CD-TLR), and target vessel revascularization (TVR).
2. Events are cumulative through time; events occurring up to the upper bound of the visit windows are considered; subjects are accountable if they were still monitored at the lower bound of the visit window. Thus, the time intervals are:
* 12 Months: events from Day 0 to Day 395
|
24 Months MAEs
Major Adverse Events (MAEs) over Time (Cumulative) - ITT population
1. Major adverse event (MAE) includes unplanned target limb amputation, cardiovascular death, clinically driven target lesion revascularization (CD-TLR), and target vessel revascularization (TVR).
2. Events are cumulative through time; events occurring up to the upper bound of the visit windows are considered; subjects are accountable if they were still monitored at the lower bound of the visit window. Thus, the time intervals are:
* 24 Months: events from Day 0 to completion of study
|
|---|---|---|---|---|
|
Freedom From Occlusion
|
17 Lesions
|
15 Lesions
|
—
|
—
|
SECONDARY outcome
Timeframe: Post-discharge (at 6-, 12-, and 24-months)Population: Patients with ABI/TBI available at both baseline and each follow-up timepoint.
Change in ankle brachial index (ABI) or tibial brachial index (TBI) if ABI unavailable at 6, 12, and 24, months, compared to baseline. Ankle-Brachial Index (ABI) is an 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 and feet; 0.4-0.9 indicates mild-moderate peripheral artery disease (PAD); 0.4 and lower indicates severe PAD. Positive change between timepoints represents a clinical improvement over time.
Outcome measures
| Measure |
Study Patients
n=41 Participants
Eligible Peripheral Artery Disease (PAD) patients who are routinely treated with atherectomy by AURYON™ Atherectomy System.
AURYON™ Atherectomy System: The AURYON™ System consists of two sub-units: 1) a single use catheter ("AURYON™ catheter"); and 2) a laser system.
The Auryon Atherectomy System and Auryon Atherectomy Catheters with aspiration are indicated for use as atherectomy devices for arterial stenoses, including in-stent restenosis (ISR), and to aspirate thrombus adjacent to stenoses in native and stented infra-inguinal arteries.
The Auryon Atherectomy System and Auryon Atherectomy Catheters without aspiration are indicated for use in the treatment, including atherectomy, of infra-inguinal stenoses and occlusions.
|
6 Months MAEs
n=42 Participants
Major Adverse Events (MAEs) over Time (Cumulative) - ITT population
1. Major adverse event (MAE) includes unplanned target limb amputation, cardiovascular death, clinically driven target lesion revascularization (CD-TLR), and target vessel revascularization (TVR).
2. Events are cumulative through time; events occurring up to the upper bound of the visit windows are considered; subjects are accountable if they were still monitored at the lower bound of the visit window. Thus, the time intervals are:
* 6 Months: events from Day 0 to Day 213
|
12 Months MAEs
n=36 Participants
Major Adverse Events (MAEs) over Time (Cumulative) - ITT population
1. Major adverse event (MAE) includes unplanned target limb amputation, cardiovascular death, clinically driven target lesion revascularization (CD-TLR), and target vessel revascularization (TVR).
2. Events are cumulative through time; events occurring up to the upper bound of the visit windows are considered; subjects are accountable if they were still monitored at the lower bound of the visit window. Thus, the time intervals are:
* 12 Months: events from Day 0 to Day 395
|
24 Months MAEs
Major Adverse Events (MAEs) over Time (Cumulative) - ITT population
1. Major adverse event (MAE) includes unplanned target limb amputation, cardiovascular death, clinically driven target lesion revascularization (CD-TLR), and target vessel revascularization (TVR).
2. Events are cumulative through time; events occurring up to the upper bound of the visit windows are considered; subjects are accountable if they were still monitored at the lower bound of the visit window. Thus, the time intervals are:
* 24 Months: events from Day 0 to completion of study
|
|---|---|---|---|---|
|
Change From Baseline in Ankle Brachial Index (ABI)/Tibial Brachial Index (TBI)
|
0.61 Ratio
Standard Deviation 1.51
|
1.05 Ratio
Standard Deviation 1.51
|
0.81 Ratio
Standard Deviation 1.55
|
—
|
SECONDARY outcome
Timeframe: Post-discharge (at 6-, 12-, and 24-months)Population: Patients with WIQ available at both baseline and each follow-up timepoint.
Change in walking impairment questionnaire (WIQ) score at 6, 12, and 24, months, compared to baseline. WIQ is a patient reported outcome (survey) to grade physical ability representing PAD progress. It has 3 sub-scales (walking speed, distance, climbing stairs), with the total score ranging between 0-100. A higher score means less impairment; positive change between timepoints represents a clinical improvement through time.
Outcome measures
| Measure |
Study Patients
n=65 Participants
Eligible Peripheral Artery Disease (PAD) patients who are routinely treated with atherectomy by AURYON™ Atherectomy System.
AURYON™ Atherectomy System: The AURYON™ System consists of two sub-units: 1) a single use catheter ("AURYON™ catheter"); and 2) a laser system.
The Auryon Atherectomy System and Auryon Atherectomy Catheters with aspiration are indicated for use as atherectomy devices for arterial stenoses, including in-stent restenosis (ISR), and to aspirate thrombus adjacent to stenoses in native and stented infra-inguinal arteries.
The Auryon Atherectomy System and Auryon Atherectomy Catheters without aspiration are indicated for use in the treatment, including atherectomy, of infra-inguinal stenoses and occlusions.
|
6 Months MAEs
n=51 Participants
Major Adverse Events (MAEs) over Time (Cumulative) - ITT population
1. Major adverse event (MAE) includes unplanned target limb amputation, cardiovascular death, clinically driven target lesion revascularization (CD-TLR), and target vessel revascularization (TVR).
2. Events are cumulative through time; events occurring up to the upper bound of the visit windows are considered; subjects are accountable if they were still monitored at the lower bound of the visit window. Thus, the time intervals are:
* 6 Months: events from Day 0 to Day 213
|
12 Months MAEs
n=45 Participants
Major Adverse Events (MAEs) over Time (Cumulative) - ITT population
1. Major adverse event (MAE) includes unplanned target limb amputation, cardiovascular death, clinically driven target lesion revascularization (CD-TLR), and target vessel revascularization (TVR).
2. Events are cumulative through time; events occurring up to the upper bound of the visit windows are considered; subjects are accountable if they were still monitored at the lower bound of the visit window. Thus, the time intervals are:
* 12 Months: events from Day 0 to Day 395
|
24 Months MAEs
Major Adverse Events (MAEs) over Time (Cumulative) - ITT population
1. Major adverse event (MAE) includes unplanned target limb amputation, cardiovascular death, clinically driven target lesion revascularization (CD-TLR), and target vessel revascularization (TVR).
2. Events are cumulative through time; events occurring up to the upper bound of the visit windows are considered; subjects are accountable if they were still monitored at the lower bound of the visit window. Thus, the time intervals are:
* 24 Months: events from Day 0 to completion of study
|
|---|---|---|---|---|
|
Change From Baseline in Walking Impairment Questionnaire (WIQ)
|
20.74 Score on a scale
Standard Deviation 28.73
|
20.02 Score on a scale
Standard Deviation 24.02
|
13.72 Score on a scale
Standard Deviation 26.55
|
—
|
SECONDARY outcome
Timeframe: Post-discharge (at 6-, 12-, and 24-months)Population: Patients with Rutherford Category available at both baseline and each follow-up timepoint.
Change in Rutherford Clinical Category at 6, 12, and 24, months, compared to baseline. Rutherford Category is a physician-assessed measurement, with 7 stages (0= Asymptomatic to 6= Severe ischemic ulcers/frank gangrene) representing PAD progress. Lower value means less impairment. Positive difference between timepoints represents a clinical deterioration over time.
Outcome measures
| Measure |
Study Patients
n=71 Participants
Eligible Peripheral Artery Disease (PAD) patients who are routinely treated with atherectomy by AURYON™ Atherectomy System.
AURYON™ Atherectomy System: The AURYON™ System consists of two sub-units: 1) a single use catheter ("AURYON™ catheter"); and 2) a laser system.
The Auryon Atherectomy System and Auryon Atherectomy Catheters with aspiration are indicated for use as atherectomy devices for arterial stenoses, including in-stent restenosis (ISR), and to aspirate thrombus adjacent to stenoses in native and stented infra-inguinal arteries.
The Auryon Atherectomy System and Auryon Atherectomy Catheters without aspiration are indicated for use in the treatment, including atherectomy, of infra-inguinal stenoses and occlusions.
|
6 Months MAEs
n=66 Participants
Major Adverse Events (MAEs) over Time (Cumulative) - ITT population
1. Major adverse event (MAE) includes unplanned target limb amputation, cardiovascular death, clinically driven target lesion revascularization (CD-TLR), and target vessel revascularization (TVR).
2. Events are cumulative through time; events occurring up to the upper bound of the visit windows are considered; subjects are accountable if they were still monitored at the lower bound of the visit window. Thus, the time intervals are:
* 6 Months: events from Day 0 to Day 213
|
12 Months MAEs
n=47 Participants
Major Adverse Events (MAEs) over Time (Cumulative) - ITT population
1. Major adverse event (MAE) includes unplanned target limb amputation, cardiovascular death, clinically driven target lesion revascularization (CD-TLR), and target vessel revascularization (TVR).
2. Events are cumulative through time; events occurring up to the upper bound of the visit windows are considered; subjects are accountable if they were still monitored at the lower bound of the visit window. Thus, the time intervals are:
* 12 Months: events from Day 0 to Day 395
|
24 Months MAEs
Major Adverse Events (MAEs) over Time (Cumulative) - ITT population
1. Major adverse event (MAE) includes unplanned target limb amputation, cardiovascular death, clinically driven target lesion revascularization (CD-TLR), and target vessel revascularization (TVR).
2. Events are cumulative through time; events occurring up to the upper bound of the visit windows are considered; subjects are accountable if they were still monitored at the lower bound of the visit window. Thus, the time intervals are:
* 24 Months: events from Day 0 to completion of study
|
|---|---|---|---|---|
|
Change From Baseline in Rutherford Clinical Category (RCC)
|
-1.80 Score on a scale
Standard Deviation 1.56
|
-2.24 Score on a scale
Standard Deviation 1.28
|
-2.19 Score on a scale
Standard Deviation 1.26
|
—
|
Adverse Events
Subjects Accountable for Safety
Serious events: 27 serious events
Other events: 26 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Subjects Accountable for Safety
n=102 participants at risk
Adverse Events (AEs) over Time (Cumulative) - ITT population
|
|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Cardiac disorders
Cardiac failure acute
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Cardiac disorders
Chest pain
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Cardiac disorders
Coronary artery disease
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Cardiac disorders
Myocardial infarction
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
General disorders and administration site conditions
Death
|
3.9%
4/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
General disorders and administration site conditions
Multiple organ dysfunction syndrome
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
General disorders and administration site conditions
Pain
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Infections and infestations
COVID-19
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Infections and infestations
Pneumonia
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Product issues
Device breakage
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Surgical and medical procedures
Arterial revascularisation
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Surgical and medical procedures
Leg amputation
|
2.0%
2/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Surgical and medical procedures
Stent placement
|
2.0%
2/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
10.8%
11/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Vascular disorders
Peripheral artery occlusion
|
2.0%
2/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Vascular disorders
Peripheral artery restenosis
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Vascular disorders
Peripheral embolism
|
2.0%
2/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Vascular disorders
Peripheral ischaemia
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Vascular disorders
Vascular stent occlusion
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
Other adverse events
| Measure |
Subjects Accountable for Safety
n=102 participants at risk
Adverse Events (AEs) over Time (Cumulative) - ITT population
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Surgical and medical procedures
Stent placement
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Vascular disorders
Hypertension
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Vascular disorders
Hypotension
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Vascular disorders
Orthostatic hypotension
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
2.0%
2/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Vascular disorders
Peripheral artery dissection
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Vascular disorders
Peripheral embolism
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
General disorders and administration site conditions
Oedema peripheral
|
2.9%
3/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
General disorders and administration site conditions
Stenosis
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
General disorders and administration site conditions
Ulcer
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Infections and infestations
COVID-19
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Infections and infestations
Herpes zoster
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Injury, poisoning and procedural complications
Fall
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Injury, poisoning and procedural complications
Femoral artery dissection
|
2.0%
2/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Injury, poisoning and procedural complications
Wound
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Investigations
Heart rate irregular
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.0%
2/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Nervous system disorders
Hypoaesthesia
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Nervous system disorders
Neuralgia
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoeic attack
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.0%
2/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Cardiac disorders
Angina pectoris
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Cardiac disorders
Chest pain
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
|
General disorders and administration site conditions
Medical device site haematoma
|
0.98%
1/102 • 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place