Infrainguinal Peripheral Artery Disease, PAD, Peripheral Arterial Disease
Conditions
Keywords
Peripheral Artery Disease, Peripheral Occlusive Disease, Peripheral Artery Stenonsis, Artery Restenosis, Arterial Occlusive Disease, Peripheral Vascular disease, Laser recanalization, Endovascular treatment or Procedure or Surgery, Calcified Lesions, Atherectomy, Intermittent Claudication, Claudication pain, Arterial Calcification, Critical Limb Ischemia, CLI, Acute Limb Ischemia, Acute Arterial Occlusion, Infra-inguinal Stenosis or Occlusion, Femoral Artery Stenosis, Femoral-Popliteal Arterial Disease, Tibial Stenosis, In-stent Restenosis, Stenotic lesion, Peripheral Artery Revascularization, Lower Limb Arterial Calcification, Laser-assisted angioplasty, Above the Knee calcification, ATK Calcification, Below the Knee Calcification, Chronic total occlusion, CTO, Superficial Femoral Artery Disease, Target Lesion revascularization, Atherectomy Catheter, Observational Study, Registry, Walking Impairment questionnaire, Intravascular ultrasound, Ankle-Brachial Pressure Index, Toe-Brachial Index, Rutherford Classification, ABI, TBI, Peak Systolic Velocity Ratio, Auryon System, Eximo Medical, AngioDynamics, B-Laser, Real World Evidence
Brief summary
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.
Detailed description
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.
Interventions
The AURYON Atherectomy System consists of two sub-units: 1) a single use catheter ("AURYON™ catheter"); and 2) a laser system.
Sponsors
Angiodynamics, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is ≥ 18 years old. 2. Subject is a candidate for atherectomy for infra-inguinal peripheral artery disease. 3. Documented symptomatic atherosclerotic peripheral artery disease with claudication or critical limb ischemia (CLI) (Rutherford Classification 2-5 ). 4. Subject is capable and willing to comply with the scheduled follow up 5. Subject is able and willing to sign a written Informed Consent Form (ICF).
Exclusion criteria
1. Target lesion is in an arterial bypass. 2. Planned use of another atherectomy device in the same procedure 3. Co-morbid condition(s) with less than 1yr anticipated survival that could limit the subject's ability to participate in the trial or to comply with follow-up requirements or impact the scientific integrity of the study. 4. Participating in another study on an interventional non-cleared device, that could impact the study results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Efficacy: Acute Procedural Success | Peri-procedural (by the end of the index procedure) | 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. |
| Primary Safety: Freedom From Peri-procedural Major Adverse Events (PPMAE) | Through discharge, an average of 5 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Major Adverse Events (MAEs) Over Time | 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). |
| Number of Patent Lesions | Post-discharge (at 6-, 12-, and 24-months) | 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. |
| Freedom From Occlusion | Post-discharge (at 6-, 12-, and 24-months) | 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) |
| Change From Baseline in Ankle Brachial Index (ABI)/Tibial Brachial Index (TBI) | Post-discharge (at 6-, 12-, and 24-months) | 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. |
| Change From Baseline in Rutherford Clinical Category (RCC) | Post-discharge (at 6-, 12-, and 24-months) | 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. |
| Change From Baseline in Walking Impairment Questionnaire (WIQ) | Post-discharge (at 6-, 12-, and 24-months) | 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. |
| Number of Participants With Device Related Complications Requiring Intervention | Till discharge, an average of 5 days | 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. |
Countries
United States
Contacts
STUDY_CHAIRTBD TBD
Baseline characteristics
| Characteristic | — |
|---|---|
| ABI/TBI (Ankle/Toe Brachial Index) at baseline | 0.73 Ratio STANDARD_DEVIATION 0.28 |
| Age, Continuous | 68.4 years STANDARD_DEVIATION 10.2 |
| Baseline Calcification level at target lesion (core lab adjudicated) 0 - None | 31 Lesions |
| Baseline Calcification level at target lesion (core lab adjudicated) 1 - Focal | 4 Lesions |
| Baseline Calcification level at target lesion (core lab adjudicated) 2 - Mild | 19 Lesions |
| Baseline Calcification level at target lesion (core lab adjudicated) 3 - Moderate | 22 Lesions |
| Baseline Calcification level at target lesion (core lab adjudicated) 4 - Severe | 17 Lesions |
| Baseline Calcification level at target lesion (core lab adjudicated) Unknown | 14 Lesions |
| Baseline % Stenosis of the target lesion (by Core laboratory) | 87.10 Percentage of Stenosis STANDARD_DEVIATION 16.58 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 65 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 16 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 13 Participants |
| Race (NIH/OMB) White | 73 Participants |
| Region of Enrollment United States | 102 participants |
| Rutherford Category at baseline | 3.64 units on a scale STANDARD_DEVIATION 0.92 |
| Sex: Female, Male Female | 39 Participants |
| Sex: Female, Male Male | 63 Participants |
| Target lesion length (by Core laboratory) | 13.6 Centimeter (cm) |
| WIQ (Walking Impairment Questionnaire) at baseline | 22.77 units on a scale STANDARD_DEVIATION 22.52 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 7 / 102 |
| other Total, other adverse events | 26 / 102 |
| serious Total, serious adverse events | 27 / 102 |
Outcome results
None listed