Clinical trial NCT05284240: Prospective, Multi-center, Single-arm Study of the Auryon Laser System for Treatment of Below-the-Knee (BTK) Arteries
Official title: Prospective, Multi-center, Single-arm Study of the Auryon Laser System for Treatment of Below-the-Knee (BTK) Arteries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: Midwest Cardiovascular Research Foundation
Sponsor class: OTHER
Collaborators: name: Angiodynamics, Inc.
First posted: 2022-03-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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
Primary purpose: TREATMENT

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

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.

3. Patient has signed approved informed consent. 4. Patient is willing to comply with the follow-up evaluations Angiographic Inclusion Criteria

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
21. Subject has evidence of intracranial or gastrointestinal bleeding within the past 3 Angiographic Exclusion Criteria

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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Primary outcomes:
measure: The Primary Safety Endpoint:
timeFrame: 30 days
measure: The Primary Performance Endpoint:
timeFrame: Index Procedure
Secondary outcomes:
measure: Serious angiographic complications
timeFrame: Index Procedure
measure: Technical success
timeFrame: Index Procedure
measure: Primary patency at 6 and 12 month
timeFrame: 6 and 12 months
measure: Clinically Relevant Target Lesion Revascularization
timeFrame: 12 months
measure: Major Adverse Events (MAE)
timeFrame: 30 days
measure: Perforations
timeFrame: Index Procedure
measure: Walking impairment questionnaire
timeFrame: 30 days, 3, 6, and 12 months
measure: EQ-5D-5L Questionnaire
timeFrame: 30 days, 3, 6, and 12 months
measure: Ankle-brachial Index (ABI) or Toe-brachial Index (TBI)
timeFrame: 30 days, 6 and 12 months
measure: Rutherford Category
timeFrame: 30 days, 3, 6, and 12 months
measure: Subgroup analysis stratified by IVUS
timeFrame: Index Procedure
measure: Healed Wounds
timeFrame: 30 days, 3, 6, and 12 months
measure: Mean Lesion Diameter
timeFrame: Index Procedure
measure: Total Dissections
timeFrame: Index Procedure
Other outcomes:
Locations:
city: Miami Beach
country: United States
facility: Palm Vascular Centers
state: Florida
city: Davenport
country: United States
facility: Midwest Cardiovascular Research Foundation
state: Iowa
Study officials:
affiliation: Midwest Cardiovascular Research Foundation
name: Nicolas Shammas
role: PRINCIPAL_INVESTIGATOR
References: