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

Peripheral Arterial Disease Clinical Trial

— PATHFINDER-I  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04229563
• Other study ID #: EX-PAD-05
• Status: Active, not recruiting
• Start date: August 4, 2020
• Est. completion date: April 17, 2023

Study information

• Verified date: February 2023
• Source: Angiodynamics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 104
• Est. completion date: April 17, 2023
• Est. primary completion date: March 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infrainguinal Peripheral Artery Disease
• PAD
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Comprehensive Cardiovascular	Davenport	Florida
United States	Midwest Cardio. research foundation	Davenport	Iowa
United States	Hurricane Cardiology	New Braunfels	Texas
United States	Pulse Cardiovacular	Scottsdale	Arizona
United States	Pima Vascular	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Angiodynamics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory endpoint: IVUS	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.	Peri-procedural (by the end of the index procedure)
Primary	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.	Peri-procedural (by the end of the index procedure)
Primary	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.	Till discharge, an average of 5 days
Secondary	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.	Till discharge, an average of 5 days
Secondary	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).	Post-discharge (at 30-days, 6-, 12-, and 24-months)
Secondary	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.	Post-discharge (at 6-, 12-, and 24-months)
Secondary	Occlusion freedom	Only for BTK lesions: freedom from occlusion (100% stenosis by DUS) combined with freedom from CD-TLR	Post-discharge (at 6-, 12-, and 24-months)
Secondary	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.	Post-discharge (at 6-, 12-, and 24-months)
Secondary	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.	Post-discharge (at 6-, 12-, and 24-months)
Secondary	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.	Post-discharge (at 6-, 12-, and 24-months)