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

NCT ID: NCT05284240

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-17
• Study Completion Date: 2024-09-25

Brief Summary

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

Detailed Description

To observe the treatment effects of the Auryon Laser Atherectomy System in treating Infrapopliteal peripheral arterial disease

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Auryon Laser Treatment Arm

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

Group Type: EXPERIMENTAL

Auryon Laser System

Intervention Type: 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.

Interventions

Auryon Laser System

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. 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.

1. Target lesions(s) must be viewed angiographically and have ≥50% stenosis. More than one lesion can be included in the same vessel.

2. Only 1 target vessel is included in the study.

3. 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.

4. Target lesion is denovo or restenotic.

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Exclusion Criteria

1. Target lesion is in a vessel graft or synthetic graft.

2. Subjects requiring dialysis.

3. Subject is unable to understand the study or has a history of non-compliance with medical advice.

4. Subject is unwilling or unable to sign the Informed Consent Form (ICF)

5. Subject is currently enrolled in another clinical investigational study that might clinically interfere with the current study endpoints.

6. Subject has a known sensitivity to contrast media and the sensitivity cannot be adequately pre-medicated for.

7. Subject has a CVA or TIA within 4 weeks prior to the Auryon procedure.

8. Planned Use of another debulking device or specialty balloons before or after the Auryon laser during the index procedure

9. Patient has any planned surgical intervention or endovascular procedure ≤14 days after the index procedure or had these procedures in the past 14 days

10. Life expectancy of less than one year judged by the investigator

11. Patient unable to take anticoagulant or antiplatelet agents

12. Platelet count less than 80,000K or bleeding disorders

13. Subject is suspected of having an active systemic infection.

14. Patient enrolled once already in the protocol

15. Planned major amputation of either leg.

16. Acute limb ischemia

17. Current Covid-19 Infection or history of Covid-19 in the past 30 days.

18. Subject is pregnant or planning on becoming pregnant.

19. Vulnerable patients who are unable to give informed consent on their own Pregnant and Vulnerable Populations. There will be no female patients who are pregnant or any vulnerable populations enrolled in the study.

20. Subject experiencing ongoing cardiac problems that per the investigator judgment would not make the subject ideal per the procedure

1. 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 no serious angiographic complications (e.g., embolism) 2. Failure to successfully treat significant non-target infra-popliteal lesions prior to treatment of the target lesion. Successful treatment is defined as obtaining ≤ 50 % residual stenosis with no serious angiographic complications (e.g., embolism).

3. Failure to successfully cross the guidewire across the target lesion; successful crossing is defined as tip of the guidewire distal to the target lesion in the absence of flow limiting dissections or perforations.

4. In-stent restenosis.

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• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Angiodynamics, Inc.

INDUSTRY

Sponsor Role: collaborator

Midwest Cardiovascular Research Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolas Shammas

Role: PRINCIPAL_INVESTIGATOR

Midwest Cardiovascular Research Foundation

Locations

Palm Vascular Centers

Miami Beach, Florida, United States

Midwest Cardiovascular Research Foundation

Davenport, Iowa, United States

Countries

United States

Other Identifiers

MCRF-P003-2021

Identifier Type: -

Identifier Source: org_study_id