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Laser zaps leg artery blockages in new trial

NCT ID NCT05916950

Disease control Sponsor: Philips Clinical & Medical Affairs Global Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a new laser device called the Thor system to treat blockages in the leg arteries caused by peripheral artery disease (PAD). About 155 adults with PAD will receive the laser treatment and be followed for a year. The main goals are to see if the device is safe and if it successfully opens the blocked arteries.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Thor laser atherectomy system (a device that uses laser energy to remove calcium blockages in leg arteries)
What this could lead to
If successful, this could offer a new, less invasive way to treat blocked leg arteries in people with peripheral artery disease, potentially improving blood flow and reducing symptoms.
What could go wrong
This is an early-stage study with only 155 participants, so results may not apply to everyone. Risks include artery damage, bleeding, or the blockage returning.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 155 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient age is ≥18 years * Patient agrees to participate and to comply with the protocol by signing an IRB approved patient consent form * Patient is able to walk unassisted or with non-motorized assistive devices * Patient has PAD with documented Rutherford Class 2-4 of the target limb * Anticipated life expectancy \>12 months, in the opinion of the investigator at the time of enrollment. Angiographic Inclusion Criteria: * Patient has de novo atherosclerotic disease of the native SFA and/or the popliteal arteries * Target lesion has ≥70% diameter stenosis by investigator via visual assessment * Target lesion length ≤150mm. Total treatment zone may not exceed 150mm, and may include one or more lesions. * Chronic total occlusion lesion length is \<100mm of the total ≤150mm target lesion * Minimum reference vessel diameter (RVD) 4.0mm by visual estimate * Target lesion crossed and intraluminal guidewire placement confirmed; successful crossing defined as tip of the guidewire distal to the target lesion in the absence of flow limiting dissections or perforations * At least one patent tibial vessel (defined as \<50% stenosis) with runoff to the foot * Target lesion has moderate to severe calcification graded using the Peripheral Academic Research Consortium (PARC) criteria Exclusion Criteria: * Patient has active infection requiring antibiotic therapy * Stenting planned within the target lesion * Known positive for COVID-19 within the last 2 weeks and actively symptomatic * Pregnant (positive pregnancy test) or currently breast feeding * Evidence of Acute Limb Ischemia in the target limb within 7 days prior to procedure * Cerebrovascular accident (CVA) \<60 days prior to procedure * Myocardial infarction \<60 days prior to procedure * History of unstable coronary artery disease or other uncontrollable comorbidity resulting in hospitalization within the last 60 days prior to baseline screening * Known contraindication to aspirin, or antiplatelet/anti-coagulant therapies required for procedure/follow-up * Known allergy to contrast media that cannot adequately be premedicated prior to study procedure * History of Thrombophilia, Heparin-induced Thrombocytopenia (HIT), or Heparin-induced Thrombotic Thrombocytopenia Syndrome (HITTS) * Serum creatinine ≥2.5mg/dL (unless dialysis-dependent) tested within 30 days prior to procedure * Planned lower limb major amputation (above the ankle) * Other surgical or endovascular procedure in the target limb that occurred within 14 days prior to index procedure or is planned on target limb for within 30 days following index procedure, with the exception of diagnostic angiography * Currently participating in any investigational device or drug clinical trial that, in the opinion of the investigator, will interfere with the conduct of the current study * The use of specialty balloons, re-entry or additional atherectomy devices is required for treatment of the target lesion. Angiographic Exclusion Criteria: * Subject has significant stenosis (\>50% stenosis) or occlusion of inflow tract before target treatment zone (e.g. iliac or common femoral) not successfully treated. * Subject requires treatment of a peripheral lesion on the ipsilateral limb distal to the target site at the time of the index procedure.

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Conditions

The condition(s) this trial relates to.

peripheral arterial disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

PAD Peripheral artery calcification Peripheral artery disease Peripheral artery stenosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    29 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ascension St. John

    RECRUITING

    Bartlesville, Oklahoma, 74006, United States

  • Atlantic Medical Imaging of New jersey

    RECRUITING

    Vineland, New Jersey, 08360, United States

  • Baylor, Scott & White, The Heart Hospital

    RECRUITING

    Plano, Texas, 75093, United States

  • Cardiovascular Institute of the South

    RECRUITING

    Houma, Louisiana, 70360, United States

  • Cardiovascular Institute of the South

    RECRUITING

    Lafayette, Louisiana, 70503, United States

  • Deborah Heart and Lung Center

    RECRUITING

    Browns Mills, New Jersey, 08015, United States

  • Guardian Research Organization

    RECRUITING

    Winter Park, Florida, 32792, United States

  • Heart and Vascular Institute of Central Jersey

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Henry Ford Hospital

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Henry Ford St John Hospital

    RECRUITING

    Detroit, Michigan, 22201, United States

  • Hospital of the University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Lankenau Institute for Medical Research

    RECRUITING

    Wynnewood, Pennsylvania, 19096, United States

  • Manatee Memorial Hospital

    RECRUITING

    Bradenton, Florida, 34205, United States

  • Mount Sinai Hospital

    RECRUITING

    New York, New York, 10029, United States

  • New York Presbyterian Hospital/Columbia University Irving Medical Center

    RECRUITING

    New York, New York, 10029, United States

  • Premier Cardiovascular Institute

    RECRUITING

    Fairborn, Ohio, 45324, United States

  • Rocky Mountain Regional VA Medical Center

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Sentara Health Research Center

    RECRUITING

    Norfolk, Virginia, 23507, United States

  • Southcoast Hospitals/Charlton Memorial Hospital

    RECRUITING

    Fall River, Massachusetts, 02720, United States

  • St. Helena Hospital

    RECRUITING

    St. Helena, California, 94574, United States

  • Tallahassee Research Institute

    RECRUITING

    Tallahassee, Florida, 32308, United States

  • The Miriam Hospital

    RECRUITING

    Providence, Rhode Island, 02905, United States

  • The Vascular Care Group

    RECRUITING

    Portland, Maine, 04106, United States

  • UPMC

    RECRUITING

    Mechanicsburg, Pennsylvania, 17050, United States

  • University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • Vascular Breakthroughs

    RECRUITING

    Leominster, Massachusetts, 04153, United States

  • Vascular Institute of Chattanooga

    RECRUITING

    Chattanooga, Tennessee, 37421, United States

  • Vascular Institute of the Midwest

    RECRUITING

    Davenport, Iowa, 52807, United States

  • Vascular Solutions of North Carolina

    RECRUITING

    Cary, North Carolina, 27518, United States

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