Prospective, Multi-center, Single-arm Study of the Auryon Laser System for Treatment of Below-the-Knee (BTK) Arteries

NCT05284240 | Completed FDA Device

• 1 other identifier: MCRF-P003-2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

The Auryon Laser Atherectomy System has been cleared by the FDA to treat infrainguinal arterial disease including in-stent restenosis

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (2)

• The Primary Safety Endpoint:

  Major Adverse Limb Events (MALE) + Post-Operative Death (POD) at 30 days, as adjudicated by the CEC, defined as a composite of: 1. All-cause death 2. Above-ankle amputation of the index limb 3. Major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis) of the index limb involving a BTK artery

  30 days

• The Primary Performance Endpoint:

  Procedure Success defined as ≤30% residual stenosis for the treated segment of the vessel without serious angiographic complications (flow-limiting dissection (D to F), perforation, distal embolization, or acute vessel closure after final treatment, as assessed by the angiographic core lab.

  Index Procedure

Secondary Outcomes (14)

• Serious angiographic complications

  Index Procedure

• Technical success

  Index Procedure

• Primary patency at 6 and 12 month

  6 and 12 months

• Clinically Relevant Target Lesion Revascularization

  12 months

• Major Adverse Events (MAE)

  30 days

Study Arms (1)

Auryon Laser Treatment Arm

EXPERIMENTAL

Auryon Laser to be used on target lesion in the below the knee artery.

Device: Auryon Laser System

Interventions

Auryon Laser System DEVICE

The Auryon BTK Study is a prospective, single arm multicenter study evaluating the safety and procedural effectiveness of the Auryon laser in treating infrapopliteal disease in patients with critical limb ischemia and claudication. The primary exposure of interest for this study is the use of the AURYON system for atherectomy.

Auryon Laser Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Subject is 18 years of age or older. 2. Critical limb ischemia (CLI) in the target limb from the distal segment (P3) of the popliteal artery to the ankle joint prior to the study procedure with Rutherford Category 4-5 in the target limb from the distal segment (P3) of the popliteal artery to the ankle joint prior to the study procedure.
• Target lesions(s) must be viewed angiographically and have ≥50% stenosis. More than one lesion can be included in the same vessel.
• Only 1 target vessel is included in the study.
• Intraluminal crossing of the lesion. If this is not certain, IVUS may be used to verify this per operator's discretion.
• Target Lesion reference vessel diameter (RVD) between 1.5 mm - 4.5 mm. by investigator estimate.
• \. Target lesion is denovo or restenotic.

You may not qualify if:

• Target lesion is in a vessel graft or synthetic graft.
• Subjects requiring dialysis.
• Subject is unable to understand the study or has a history of non-compliance with medical advice.
• Subject is unwilling or unable to sign the Informed Consent Form (ICF)
• Subject is currently enrolled in another clinical investigational study that might clinically interfere with the current study endpoints.
• Subject has a known sensitivity to contrast media and the sensitivity cannot be adequately pre-medicated for.
• Subject has a CVA or TIA within 4 weeks prior to the Auryon procedure.
• Planned Use of another debulking device or specialty balloons before or after the Auryon laser during the index procedure
• Patient has any planned surgical intervention or endovascular procedure ≤14 days after the index procedure or had these procedures in the past 14 days
• Life expectancy of less than one year judged by the investigator
• Patient unable to take anticoagulant or antiplatelet agents
• Platelet count less than 80,000K or bleeding disorders
• Subject is suspected of having an active systemic infection.
• Patient enrolled once already in the protocol
• Planned major amputation of either leg.

Sponsors & Collaborators

• Midwest Cardiovascular Research Foundation: lead
• Angiodynamics, Inc.: collaborator

Study Sites (2)

Palm Vascular Centers

Miami Beach, Florida, 33140, United States

Location

Midwest Cardiovascular Research Foundation

Davenport, Iowa, 52801, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Nicolas Shammas

  Midwest Cardiovascular Research Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, multicenter, single arm study Patients with symptomatic peripheral vascular disease who underwent infrapopliteal percutaneous intervention using the Auryon laser system 4 sites in United States

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: March 17, 2022
• Study Start: March 17, 2022
• Primary Completion: September 25, 2024
• Study Completion: September 25, 2024
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)