Clinical trial NCT04229563: Post-Market Registry of AURYON™ Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease
Official title: PATHFINDER I: Post-Market Registry of AURYON™ Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease (PATHFINDER-Registry, EX-PAD-05)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infrainguinal Peripheral Artery Disease
Peripheral Arterial Disease
PAD
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
Lead sponsor: Angiodynamics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-01-18
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with infra-inguinal PAD undergoing atherectomy with the AURYON™ Atherectomy System.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary Efficacy: Acute Procedural Success
timeFrame: Peri-procedural (by the end of the index procedure)
measure: Primary Safety: Freedom from Peri-procedural major adverse events (PPMAE)
timeFrame: Till discharge, an average of 5 days
Secondary outcomes:
measure: Rate of device related complications requiring intervention
timeFrame: Till discharge, an average of 5 days
measure: Rates of MAEs over time
timeFrame: Post-discharge (at 30-days, 6-, 12-, and 24-months)
measure: Patency rate
timeFrame: Post-discharge (at 6-, 12-, and 24-months)
measure: Occlusion freedom
timeFrame: Post-discharge (at 6-, 12-, and 24-months)
measure: Clinical outcome 1 - ankle brachial index (ABI)
timeFrame: Post-discharge (at 6-, 12-, and 24-months)
measure: Clinical outcome 2 - walking impairment questionnaire (WIQ)
timeFrame: Post-discharge (at 6-, 12-, and 24-months)
measure: Clinical outcome 3 - Rutherford clinical categories (RCC)
timeFrame: Post-discharge (at 6-, 12-, and 24-months)
Other outcomes:
measure: Exploratory endpoint: IVUS
timeFrame: Peri-procedural (by the end of the index procedure)
Locations:
city: Scottsdale
country: United States
facility: Pulse Cardiovacular
state: Arizona
city: Tucson
country: United States
facility: Pima Vascular
state: Arizona
city: Davenport
country: United States
facility: Comprehensive Cardiovascular
state: Florida
city: Davenport
country: United States
facility: Midwest Cardio. research foundation
state: Iowa
city: New Braunfels
country: United States
facility: Hurricane Cardiology
state: Texas
Study officials:
name: TBD TBD
role: STUDY_CHAIR
References: