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Peripheral Arterial DiseaseNCT05284240

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

A study testing Auryon Laser System in people with Peripheral Arterial Disease, run by Midwest Cardiovascular Research Foundation at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Peripheral Arterial Disease
What is being tested?
Auryon Laser System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesUnited States
Study dates
17 Mar 2022to 25 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
  • -

Who cannot join

  • 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.
Show all 25Show fewer
  • 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.
  • -

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Midwest Cardiovascular Research Foundation

    Davenport, Iowa, 52801

  • Palm Vascular Centers

    Miami Beach, Florida, 33140

Other trials in United States

About this study

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

Read the detailed description

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

Being tested
Auryon Laser System
Medical subject headings
Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Auryon Laser SystemDevice

    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.

Study groups in NCT05284240
Study groupRoleWhat they receive
Auryon Laser Treatment ArmExperimentalAuryon Laser to be used on target lesion in the below the knee artery.
Receives: Device: Auryon Laser System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 30 days

  2. 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.

    Measured: Index Procedure

Secondary outcomes (14)

  1. Serious angiographic complications

    flow-limiting dissection (D to F, perforation, distal embolization, or acute vessel closure) as assessed by the angiographic core lab

    Measured: Index Procedure

  2. 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

    Measured: Index Procedure

  3. 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

    Measured: 6 and 12 months

  4. 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)

    Measured: 12 months

  5. 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

    Measured: 30 days

  6. Perforations

    Perforations that require an intervention

    Measured: Index Procedure

  7. Walking impairment questionnaire

    reported as change from baseline

    Measured: 30 days, 3, 6, and 12 months

  8. EQ-5D-5L Questionnaire

    reported as change from baseline

    Measured: 30 days, 3, 6, and 12 months

  9. Ankle-brachial Index (ABI) or Toe-brachial Index (TBI)

    reported as change from baseline

    Measured: 30 days, 6 and 12 months

  10. Rutherford Category

    reported as change from baseline

    Measured: 30 days, 3, 6, and 12 months

  11. 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

    Measured: Index Procedure

  12. Healed Wounds

    Number of healed wounds

    Measured: 30 days, 3, 6, and 12 months

  13. Mean Lesion Diameter

    IVUS subgroup: 20 patients. All will be evaluated for MLA pre and post laser and post final treatment.

    Measured: Index Procedure

  14. Total Dissections

    The presence and number of dissections will be classified based on iDissection classification

    Measured: Index Procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2022
  2. Study start17 Mar 2022
  3. Primary completion25 Sep 2024
  4. Study completion25 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05284240
Sponsor's protocol ID
MCRF-P003-2021
Status last verified
Nov 2024
First submitted
2 Feb 2022
Last updated
21 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Auryon Laser System in people with Peripheral Arterial Disease, run by Midwest Cardiovascular Research Foundation at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Primary Safety Endpoint: (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05284240.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.

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