The PATHFINDER I Registry is a prospective, non-randomized, single arm, multicenter observational study. It is a pilot registry study towards a subsequent large pivotal phase registry. 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 towards a subsequent large pivotal registry (PATHFINDER II), 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
104
The AURYON™ 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
Midwest Cardio. research foundation
Davenport, Iowa, United States
Primary Efficacy: Acute Procedural Success
Percentage of subjects with successful revascularization of target vessel defined as ≤30% residual stenosis at the index 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: Till discharge, an average of 5 days
Rate of device related complications requiring intervention
Rate of device related complications requiring intervention, defined as peri procedural 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
Rates of MAEs over time
Rates of 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)
Patency rate
Patency rate, defined as \<50% stenosis at the treated lesion, with peak systolic velocity ratio (PSVR) of \<2.5, as assessed quantitatively by Duplex ultrasonography (DUS) performed in a lab that achieved Vascular Laboratory Accreditation, at 6, 12, and 24 months.
Time frame: Post-discharge (at 6-, 12-, and 24-months)
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Hurricane Cardiology
New Braunfels, Texas, United States
Occlusion freedom
Only for BTK lesions: freedom from occlusion (100% stenosis by DUS) combined with freedom from CD-TLR
Time frame: Post-discharge (at 6-, 12-, and 24-months)
Clinical outcome 1 - ankle brachial index (ABI)
Change in ankle brachial index (ABI or TBI if needed) at 6, 12, and 24, months, compared to baseline. Ankle-Brachial Index (ABI) si 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 \& 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.
Time frame: Post-discharge (at 6-, 12-, and 24-months)
Clinical outcome 2 - walking impairment questionnaire (WIQ)
Change in walking impairment questionnaire (WIQ) score at 6, 12, and 24, months, compared to baseline. WIQ is 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 clinical improvement through time and vice versa.
Time frame: Post-discharge (at 6-, 12-, and 24-months)
Clinical outcome 3 - Rutherford clinical categories (RCC)
Change in Rutherford clinical category at 6, 12, and 24, months, compared to baseline. Rutherford Classification is 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.
Time frame: Post-discharge (at 6-, 12-, and 24-months)