PATHFINDER-I: Post-Market Registry of AURYON™ Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease

Sponsor

Angiodynamics, Inc. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04229563

Collaborator

(none)

104

Enrollment

Locations

31.8

Anticipated Duration (Months)

20.8

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Infrainguinal Peripheral Artery Disease Peripheral Arterial Disease PAD	Device: AURYON™ System

Detailed Description

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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

104 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

PATHFINDER I: Post-Market Registry of AURYON™ Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease (PATHFINDER-Registry, EX-PAD-05)

Actual Study Start Date :

Aug 4, 2020

Actual Primary Completion Date :

Mar 17, 2021

Anticipated Study Completion Date :

Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Study patients Eligible PAD patients who are routinely treated with atherectomy by AURYON™ Atherectomy System.	Device: AURYON™ System The AURYON™ System consists of two sub-units: 1) a single use catheter ("AURYON™ catheter"); and 2) a laser system.

Arm

Intervention/Treatment

Study patients

Eligible PAD patients who are routinely treated with atherectomy by AURYON™ Atherectomy System.

Device: AURYON™ System

The AURYON™ System consists of two sub-units: 1) a single use catheter ("AURYON™ catheter"); and 2) a laser system.

Outcome Measures

Primary Outcome Measures

Primary Efficacy: Acute Procedural Success [Peri-procedural (by the end of the index procedure)]
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.
Primary Safety: Freedom from Peri-procedural major adverse events (PPMAE) [Till 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 Outcome Measures

Rate of device related complications requiring intervention [Till discharge, an average of 5 days]
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.
Rates of MAEs over time [Post-discharge (at 30-days, 6-, 12-, and 24-months)]
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).
Patency rate [Post-discharge (at 6-, 12-, and 24-months)]
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.
Occlusion freedom [Post-discharge (at 6-, 12-, and 24-months)]
Only for BTK lesions: freedom from occlusion (100% stenosis by DUS) combined with freedom from CD-TLR
Clinical outcome 1 - ankle brachial index (ABI) [Post-discharge (at 6-, 12-, and 24-months)]
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.
Clinical outcome 2 - 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 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.
Clinical outcome 3 - Rutherford clinical categories (RCC) [Post-discharge (at 6-, 12-, and 24-months)]
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.

Other Outcome Measures

Exploratory endpoint: IVUS [Peri-procedural (by the end of the index procedure)]
Intravascular ultrasound assessment pre- and post-Auryon and correlation with angiographic findings (e.g. lesion length, MLA -minimal lumen area gain, calcium severity and removal, etc.). This endpoint will be analyzed only for cases that used IVUS as a routine practice in the index procedure.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subject is ≥ 18 years old.
Subject is a candidate for atherectomy for infra-inguinal peripheral artery disease.
Documented symptomatic atherosclerotic peripheral artery disease with claudication or critical limb ischemia (CLI) (Rutherford Classification 2-5 ).
Subject is capable and willing to comply with the scheduled follow up
Subject is able and willing to sign a written Informed Consent Form (ICF).

Exclusion Criteria:

Target lesion is in an arterial bypass.
Planned use of another atherectomy device in the same procedure
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.
Participating in another study on an interventional non-cleared device, that could impact the study results

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pulse Cardiovacular	Scottsdale	Arizona	United States	85259
2	Pima Vascular	Tucson	Arizona	United States	85718
3	Comprehensive Cardiovascular	Davenport	Florida	United States	33837
4	Midwest Cardio. research foundation	Davenport	Iowa	United States	52803
5	Hurricane Cardiology	New Braunfels	Texas	United States	78130