An observational study in Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease and PAD, sponsored by Angiodynamics, Inc.. Completed at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-18.
Sponsored by Angiodynamics, Inc. · Observational
The PATHFINDER Registry is a prospective, non-randomized, single arm, multicenter observational study. This pilot registry is aimed to evaluate the performance (peri-procedural) and clinical outcomes (intermediate and long-term) of the AURYON Atherectomy System, within the initial launch phase of the product in the market.
US multicenter, prospective, single-arm, observational post market Registry. A pilot registry aimed to evaluate the safety and efficacy of Auryon Atherectomy System in the treatment of de novo, re-stenotic and ISR lesions in infra-inguinal arteries of Peripheral Artery Diseases (PAD) subjects, in a real-world setting within the initial launch phase of the product in the market.
1,377 studies on the registry are indexed under Peripheral Arterial Disease; 275 are open to participants now.
This study's enrollment of 102 is below the median of 188 across 398 observational studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Angiodynamics, Inc. is the lead sponsor of 22 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with infra-inguinal PAD undergoing atherectomy with the AURYON Atherectomy System.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Eligible PAD patients who are routinely treated with atherectomy by AURYON Atherectomy System.
Device: AURYON Atherectomy System
The AURYON Atherectomy System consists of two sub-units: 1) a single use catheter ("AURYON™ catheter"); and 2) a laser system.
Primary Efficacy: Acute Procedural Success
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.
Time frame: Peri-procedural (by the end of the index procedure)
Primary Safety: Freedom From Peri-procedural Major Adverse Events (PPMAE)
Percentage 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.
Time frame: Through discharge, an average of 5 days
Number of Participants With Device Related Complications Requiring Intervention
Number 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.
Time frame: Till discharge, an average of 5 days
Number of Participants With Major Adverse Events (MAEs) Over Time
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).
Time frame: Post-discharge (at 30-days, 6-, 12-, and 24-months)
Number of Patent Lesions
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.
Time frame: Post-discharge (at 6-, 12-, and 24-months)
Freedom From Occlusion
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)
Time frame: Post-discharge (at 6-, 12-, and 24-months)
Change From Baseline in Ankle Brachial Index (ABI)/Tibial Brachial Index (TBI)
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.
Time frame: Post-discharge (at 6-, 12-, and 24-months)
Change From Baseline in Walking Impairment Questionnaire (WIQ)
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.
Time frame: Post-discharge (at 6-, 12-, and 24-months)
Change From Baseline in Rutherford Clinical Category (RCC)
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.
Time frame: Post-discharge (at 6-, 12-, and 24-months)
| Milestone | Study Patients |
|---|---|
| Started | 102 |
| Completed | 68 |
| Not completed | 34 |
| Withdrew: Adverse event | 7 |
| Withdrew: Death | 1 |
| Withdrew: Lost to follow-up | 14 |
| Withdrew: Withdrawal by subject | 12 |
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.
| Lesions | Study Patients |
|---|---|
| Primary Efficacy: Acute Procedural Success | 69 |
Percentage 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.
| Participants | Study Patients |
|---|---|
| Primary Safety: Freedom From Peri-procedural Major Adverse Events (PPMAE) | 97 |
Number 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.
| Participants | Study Patients |
|---|---|
| Number of Participants With Device Related Complications Requiring Intervention | 5 |
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).
| Participants | 30 Days MAEs | 6 Months MAEs | 12 Months MAEs | 24 Months MAEs |
|---|---|---|---|---|
| Number of Participants With Major Adverse Events (MAEs) Over Time | 3 | 9 | 10 | 13 |
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.
| Lesions | 6 Months Patency | 12 Months Patency | 24 Months Patency |
|---|---|---|---|
| Number of Patent Lesions | 49 | 48 | 37 |
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)
| Lesions | 6 Months Patency | 12 Months Patency |
|---|---|---|
| Freedom From Occlusion | 17 | 15 |
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.
| Ratio | ABI/TBI (Ankle/Toe Brachial Index) at 6 Months | ABI/TBI (Ankle/Toe Brachial Index) at 12 Months | ABI/TBI (Ankle/Toe Brachial Index) at 24 Months |
|---|---|---|---|
| Change From Baseline in Ankle Brachial Index (ABI)/Tibial Brachial Index (TBI) | 0.61 ± 1.51 | 1.05 ± 1.51 | 0.81 ± 1.55 |
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.
| Score on a scale | WIQ (Walking Impairment Questionnaire) at 6 Months | WIQ (Walking Impairment Questionnaire) at 12 Months | WIQ (Walking Impairment Questionnaire) at 24 Months |
|---|---|---|---|
| Change From Baseline in Walking Impairment Questionnaire (WIQ) | 20.74 ± 28.73 | 20.02 ± 24.02 | 13.72 ± 26.55 |
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.
| Score on a scale | Rutherford Category at 6 Months | Rutherford Category at 12 Months | Rutherford Category at 24 Months |
|---|---|---|---|
| Change From Baseline in Rutherford Clinical Category (RCC) | -1.80 ± 1.56 | -2.24 ± 1.28 | -2.19 ± 1.26 |
Collected over 24 months post procedure (from Day 0 till study termination). Subjects without events considered if they get monitored at Day 700.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Subjects Accountable for Safety | 7/102 (6.9%) | 27/102 (26.5%) | 26/102 (25.5%) |
| Event | Subjects Accountable for Safety |
|---|---|
| Peripheral arterial occlusive diseaseVascular disorders | 11/102 |
| DeathGeneral disorders and administration site conditions | 4/102 |
| Leg amputationSurgical and medical procedures | 2/102 |
| Stent placementSurgical and medical procedures | 2/102 |
| Peripheral artery occlusionVascular disorders | 2/102 |
| Peripheral embolismVascular disorders | 2/102 |
| Acute myocardial infarctionCardiac disorders | 1/102 |
| Cardiac failure acuteCardiac disorders | 1/102 |
| Chest painCardiac disorders | 1/102 |
| Coronary artery diseaseCardiac disorders | 1/102 |
| Event | Subjects Accountable for Safety |
|---|---|
| Oedema peripheralGeneral disorders and administration site conditions | 3/102 |
| Femoral artery dissectionInjury, poisoning and procedural complications | 2/102 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 2/102 |
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 2/102 |
| Peripheral arterial occlusive diseaseVascular disorders | 2/102 |
| AnaemiaBlood and lymphatic system disorders | 1/102 |
| Angina pectorisCardiac disorders | 1/102 |
| Chest painCardiac disorders | 1/102 |
| DiarrhoeaGastrointestinal disorders | 1/102 |
| Medical device site haematomaGeneral disorders and administration site conditions | 1/102 |
| Age, Continuous(years) | Study Patients |
|---|---|
| Mean | 68.4 ± 10.2 |
| Sex: Female, Male(Participants) | Study Patients |
|---|---|
| Female | 39 |
| Male | 63 |
| Race (NIH/OMB)(Participants) | Study Patients |
|---|---|
| American Indian or Alaska Native | 2 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 14 |
| White | 73 |
| More than one race | 0 |
| Unknown or Not Reported | 13 |
| Ethnicity (NIH/OMB)(Participants) | Study Patients |
|---|---|
| Hispanic or Latino | 21 |
| Not Hispanic or Latino | 65 |
| Unknown or Not Reported | 16 |
| Region of Enrollment(participants) | Study Patients |
|---|---|
| United States | 102 |
| Rutherford Category at baseline(units on a scale) | Study Patients |
|---|---|
| Mean | 3.64 ± 0.92 |
| WIQ (Walking Impairment Questionnaire) at baseline(units on a scale) | Study Patients |
|---|---|
| Mean | 22.77 ± 22.52 |
| ABI/TBI (Ankle/Toe Brachial Index) at baseline(Ratio) | Study Patients |
|---|---|
| Mean | 0.73 ± 0.28 |
3 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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