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

Primary Purpose

Peripheral Arterial Disease

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Auryon Laser System
Sponsored by
Midwest Cardiovascular Research Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

-

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.

-

Sites / Locations

  • Palm Vascular Centers
  • Midwest Cardiovascular Research Foundation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Auryon Laser Treatment Arm

Arm Description

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

Outcomes

Primary Outcome Measures

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: All-cause death Above-ankle amputation of the index limb Major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis) of the index limb involving a BTK artery
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.

Secondary Outcome Measures

Serious angiographic complications
flow-limiting dissection (D to F, perforation, distal embolization, or acute vessel closure) as assessed by the angiographic core lab
Technical success
defined as residual stenosis ≤50% in the target lesion after Auryon laser and prior to adjunctive balloon treatment without significant angiographic complications, as assessed by the angiographic core lab
Primary patency at 6 and 12 month
s defined as the absence of both total occlusion (100% diameter stenosis by DUS) in all of the target lesions, as well as a Clinically-Driven Target Lesion Revascularization (CD-TLR) (definition in D below). An alternative patency analysis will be done with patency defined as the presence of significant restenosis at the treated site using PSVR of ≤ 2.4 as the threshold for patency and absence of CD-TLR
Clinically Relevant Target Lesion Revascularization
(CD-TLR) at 30 days, 3, 6, and 12 months defined as recurrence of symptoms (worsening by one Rutherford Becker Category from post index procedure) with an objective evidence of obstructive disease (occlusion or PSVR > 2.4 by DUS; or ABI change by 0.15 from post procedure ABI)
Major Adverse Events (MAE)
Composite Need for emergency surgical revascularization of target limb Unplanned target limb major amputation (above the ankle) Symptomatic thrombus or distal emboli that require surgical, mechanical, or pharmacologic means to improve flow, and extend hospitalization
Perforations
Perforations that require an intervention
Walking impairment questionnaire
reported as change from baseline
EQ-5D-5L Questionnaire
reported as change from baseline
Ankle-brachial Index (ABI) or Toe-brachial Index (TBI)
reported as change from baseline
Rutherford Category
reported as change from baseline
Subgroup analysis stratified by IVUS
Subgroup analysis stratified by IVUS vs non IVUS patients for the primary performance endpoint and the following secondary endpoints: Final Balloon Size used to dilate lesion post laser, CD-target lesion revascularization and clinical patency
Healed Wounds
Number of healed wounds
Mean Lesion Diameter
IVUS subgroup: 20 patients. All will be evaluated for MLA pre and post laser and post final treatment.
Total Dissections
The presence and number of dissections will be classified based on iDissection classification

Full Information

First Posted
February 2, 2022
Last Updated
October 18, 2023
Sponsor
Midwest Cardiovascular Research Foundation
Collaborators
Angiodynamics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05284240
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 17, 2022 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Midwest Cardiovascular Research Foundation
Collaborators
Angiodynamics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Auryon Laser Treatment Arm
Arm Type
Experimental
Arm Description
Auryon Laser to be used on target lesion in the below the knee artery.
Intervention Type
Device
Intervention Name(s)
Auryon Laser System
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Primary Safety Endpoint:
Description
Major Adverse Limb Events (MALE) + Post-Operative Death (POD) at 30 days, as adjudicated by the CEC, defined as a composite of: All-cause death Above-ankle amputation of the index limb Major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis) of the index limb involving a BTK artery
Time Frame
30 days
Title
The Primary Performance Endpoint:
Description
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.
Time Frame
Index Procedure
Secondary Outcome Measure Information:
Title
Serious angiographic complications
Description
flow-limiting dissection (D to F, perforation, distal embolization, or acute vessel closure) as assessed by the angiographic core lab
Time Frame
Index Procedure
Title
Technical success
Description
defined as residual stenosis ≤50% in the target lesion after Auryon laser and prior to adjunctive balloon treatment without significant angiographic complications, as assessed by the angiographic core lab
Time Frame
Index Procedure
Title
Primary patency at 6 and 12 month
Description
s defined as the absence of both total occlusion (100% diameter stenosis by DUS) in all of the target lesions, as well as a Clinically-Driven Target Lesion Revascularization (CD-TLR) (definition in D below). An alternative patency analysis will be done with patency defined as the presence of significant restenosis at the treated site using PSVR of ≤ 2.4 as the threshold for patency and absence of CD-TLR
Time Frame
6 and 12 months
Title
Clinically Relevant Target Lesion Revascularization
Description
(CD-TLR) at 30 days, 3, 6, and 12 months defined as recurrence of symptoms (worsening by one Rutherford Becker Category from post index procedure) with an objective evidence of obstructive disease (occlusion or PSVR > 2.4 by DUS; or ABI change by 0.15 from post procedure ABI)
Time Frame
12 months
Title
Major Adverse Events (MAE)
Description
Composite Need for emergency surgical revascularization of target limb Unplanned target limb major amputation (above the ankle) Symptomatic thrombus or distal emboli that require surgical, mechanical, or pharmacologic means to improve flow, and extend hospitalization
Time Frame
30 days
Title
Perforations
Description
Perforations that require an intervention
Time Frame
Index Procedure
Title
Walking impairment questionnaire
Description
reported as change from baseline
Time Frame
30 days, 3, 6, and 12 months
Title
EQ-5D-5L Questionnaire
Description
reported as change from baseline
Time Frame
30 days, 3, 6, and 12 months
Title
Ankle-brachial Index (ABI) or Toe-brachial Index (TBI)
Description
reported as change from baseline
Time Frame
30 days, 6 and 12 months
Title
Rutherford Category
Description
reported as change from baseline
Time Frame
30 days, 3, 6, and 12 months
Title
Subgroup analysis stratified by IVUS
Description
Subgroup analysis stratified by IVUS vs non IVUS patients for the primary performance endpoint and the following secondary endpoints: Final Balloon Size used to dilate lesion post laser, CD-target lesion revascularization and clinical patency
Time Frame
Index Procedure
Title
Healed Wounds
Description
Number of healed wounds
Time Frame
30 days, 3, 6, and 12 months
Title
Mean Lesion Diameter
Description
IVUS subgroup: 20 patients. All will be evaluated for MLA pre and post laser and post final treatment.
Time Frame
Index Procedure
Title
Total Dissections
Description
The presence and number of dissections will be classified based on iDissection classification
Time Frame
Index Procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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. 4. Target lesion is denovo or restenotic. - Exclusion Criteria: 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. Acute limb ischemia Current Covid-19 Infection or history of Covid-19 in the past 30 days. Subject is pregnant or planning on becoming pregnant. 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. 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 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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Shammas
Organizational Affiliation
Midwest Cardiovascular Research Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Palm Vascular Centers
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Midwest Cardiovascular Research Foundation
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52801
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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