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.
Study Type
OBSERVATIONAL
Enrollment
102
The AURYON Atherectomy System consists of two sub-units: 1) a single use catheter ("AURYON™ catheter"); and 2) a laser system.
Pulse Cardiovacular
Scottsdale, Arizona, United States
Pima Vascular
Tucson, Arizona, United States
Comprehensive Cardiovascular
Davenport, Florida, United States
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.
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First Coast Cardiovascular Institute
Jacksonville, Florida, United States
Amavita Clinical Research
Miami, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Midwest Cardio. research foundation
Davenport, Iowa, United States
NJ Endovascular Amputation Prevention
Clifton, New Jersey, United States
Medical City Heart and Spine
Dallas, Texas, United States
Hurricane Cardiology
New Braunfels, Texas, United States
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)