Clinical trial NCT06777901: Auryon Atherectomy System With Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone
Official title: Randomized Controlled Trial of the Auryon Atherectomy System Used in Combination With Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone Treating Infrapopliteal Lesions in Subjects With Critical Limb Ischemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Peripheral Arterial Diseases
Lead sponsor: Angiodynamics, Inc.
Sponsor class: INDUSTRY
First posted: 2025-01-16
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if the Auryon Atherectomy System with balloon angioplasty safe and effective in treating lower limb blockages. The main question it aims to answer is: Is treatment with Auryon Atherectomy System more effective than angioplasty alone in preventing death, amputation, revascularization and improving patency? Researchers will compare the Auryon Atherectomy System with balloon angioplasty to balloon angioplasty alone.

Detailed description: Up to 1500 subjects who do not meet the inclusion/exclusion criteria for the randomized study may satisfy the eligibility criteria for, and be enrolled in, the observational study.

Eligibility criteria: Inclusion Criteria:

* Age of subject is ≥ 18.
* Estimated life expectancy ≥1 year.
* Subject is able and willing to comply with all assessments in the study.
* Subject has been informed of the nature of the study, agrees to participate, and has signed the approved consent form.
* Rutherford Category classification of 4 or 5 of the target limb.
* Subject is a suitable candidate for angiography and endovascular intervention in the opinion of the investigator or per hospital guidelines.

Angiographic Inclusion Criteria

* Target lesion that is located in a native, de novo infra-popliteal artery (extending from P3 of the popliteal artery to the margin of the ankle mortise).
* Target lesions(s) must be viewed angiographically and have 50-100% stenosis.
* Only a single lesion is allowed per subject.
* The vessel segment distal to the target lesion must be patent all the way to the ankle, with no significant lesion (≥ 50% stenosis).
* Lesion length ≥50mm and ≤300mm.
* Intraluminal crossing of the lesion. Successful crossing is defined as tip of the guidewire distal to the target lesion in the absence of flow limiting dissections or perforations. If this is not certain, IVUS or OCT may be used to verify this at the operator's discretion.
* Target Lesion reference vessel diameter (RVD) between 1.5mm - 4.5mm by investigator estimate.
* Subject has at least one patent tibial vessel on the target leg with 1-vessel runoff to the foot, defined as stenosis ≤50%.

Exclusion Criteria:

* Target lesion is in a vessel graft or synthetic graft.
* Treatment of target lesion with radial access.
* Planned target limb major amputation (above-the-ankle).
* Acute limb ischemia or required thrombolysis as a primary treatment modality of the target limb.
* History of prior endovascular or surgical procedure on the index limb within 30 days prior to enrollment or planned within 30 days of the index procedure.
* Subject is pregnant or breastfeeding. (Female subjects of childbearing potential must be non-breastfeeding and have a negative pregnancy test ≤ 7 days before the procedure.)
* Subject has a known coagulopathy or has bleeding diatheses/disorder, thrombocytopenia with platelet count less than 100,000/microliter / less than 80,000K.
* Subject in whom antiplatelet or anticoagulant therapy is contraindicated.
* Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
* Myocardial infarction within 60 days prior to enrollment.
* History of stroke/CVA/TIA within 60 days prior to enrollment.
* History of thrombolytic therapy within 14 days of enrollment.
* Subject has acute or chronic renal disease defined as serum creatinine of \>2.5 mg/dL or \>220 umol/L, or is on dialysis.
* Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
* Subject has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the study requirements and evaluations pre- and post-treatment.
* Subject experiencing ongoing cardiac problems that per the investigator judgment would not make the subject ideal per the procedure.
* Subject has evidence of intracranial or gastrointestinal bleeding within the past 3 months.

Angiographic Exclusion Criteria

* Failure to treat clinically significant inflow lesions in the contralateral iliac, ipsilateral iliac, femoral, or P1-P2 segments of the popliteal arteries with ≤30
* Residual stenosis, and/or serious angiographic complications (e.g., embolism) prior to the investigational device usage.
* Failure to perioperatively successfully treat significant non-target infra-popliteal lesions prior to treatment of the target lesion (during the index procedure). Successful treatment is defined as obtaining ≤50% residual stenosis with no serious angiographic complications (e.g., embolism).
* The use of drug-eluting balloons, re-entry or other atherectomy devices.

Subjects that do not meet eligibility criteria for the randomized controlled trial are eligible to be enrolled in the observational study.

Observational Study Inclusion Criteria:

* Subjects intended to be treated with the Auryon Atherectomy System for de-novo, restenotic or ISR lesions of the infra-popliteal arteries.
* Subjects presenting with symptomatic PAD with claudication or CLI by Rutherford Category 2 - 6 of the target limb.
* Age of subject is ≥ 18.
* Subject has been informed of the nature of the study, agrees to participate, and has signed the approved study consent form.

Observational Study Exclusion Criteria:

* Subjects with any medical condition that would make him/her an inappropriate candidate for treatment with Auryon Atherectomy System as per Instructions for Use (IFU) or investigator's opinion.
* Subject is pregnant or breastfeeding. (Female subjects of childbearing potential must be non-breastfeeding and have a negative pregnancy test ≤ 7 days before the procedure.)
* Subject is already enrolled in other investigational (interventional) studies that would interfere with study endpoints.

Primary outcomes:
measure: Win-ratio comparing subjects in the treatment group versus the control group on the components of the composite endpoints in a hierarchical fashion at 12 months
timeFrame: From enrollment to the end of treatment at 12 months
Secondary outcomes:
measure: Device Success
timeFrame: Measured upon completion of the index procedure
measure: Procedural Success
timeFrame: Measured upon completion of the index procedure
measure: Clinical Success
timeFrame: Measured upon completion of the index procedure prior to discharge.
measure: Secondary Duplex Ultrasound Imaging Measures
timeFrame: Measured at Hospital Discharge (12-24 hours post-procedure or prior to discharge, whichever comes first), 30 days, and 6, 12, 24 months
measure: Primary sustained clinical improvement
timeFrame: Measured at 30 days, and 6, 12, 24 months
measure: Secondary Sustained Clinical Improvement
timeFrame: Measured at 30 days, and 6, 12, 24 months
measure: Major Amputation
timeFrame: Measured at 30 days, and 6, 12, 24 months
measure: Amputation-free survival
timeFrame: Measured at 30 days, and 6, 12, 24 months
measure: Primary Assisted Patency
timeFrame: Measured at 30 days, and 6, 12, 24 months
measure: Secondary Patency
timeFrame: Measured at 30 days, and 6, 12, 24 months
measure: Clinically Driven Target Vessel Revascularization (CD-TVR)
timeFrame: Measured at 30 days, and 6, 12, 24 months
measure: Rutherford Caregory
timeFrame: Measured at 30 days, and 6, 12, 24 months
measure: Ankle Brachial Index/Toe-Brachial Index
timeFrame: Measured at 30 days, and 6, 12, 24 months
measure: Quality of Life (QOL)
timeFrame: Measured at 30 days, and 6, 12, 24 months
measure: Rate of Major Adverse Limb Events
timeFrame: Measured at 30 days, and 6, 12, 24 months
measure: Rate of major cardiovascular event
timeFrame: Measured at 30 days, and 6, 12, 24 months
measure: All-Cause Mortality
timeFrame: Measured at 30 days, and 6, 12, 24 months
measure: Wound Healing
timeFrame: Measured at 30 days, and 6, 12, 24 months
measure: Wound, Ischemia, foot Infection (WIfI) Classification
timeFrame: Measured at Discharge, 30 days, and 6, 12, 24 months
measure: Bailout Stenting
timeFrame: Measured upon completion of the index procedure prior to discharge.
measure: Intravascular Imaging (IVI) analysis
timeFrame: Measured during the index procedure
measure: Quality of Life (QOL)
timeFrame: Measured at 30 days, and 6, 12, 24 months
measure: Intravascular Imaging (IVI) analysis
timeFrame: Measured during the index procedure
measure: Intravascular Imaging (IVI) analysis
timeFrame: Measured during the index procedure
Other outcomes:
Locations:
city: Gray
country: United States
facility: CIS Grey ASC
state: Louisiana
Study officials:
References: