Recruiting

Observational StudyThe THOR IDE Study

Sponsor:

Philips Clinical & Medical Affairs Global

Code:

NCT05916950

Conditions

Peripheral Artery Disease

Peripheral Artery Stenosis

Peripheral Artery Calcification

PAD

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Thor laser atherectomy

Study Details

Brief summary:

The goal of this clinical trial is to test the Thor system in adult (≥ 18 year old) patients with de novo (new, never treated) calcified lesions in infrainguinal (leg) arteries (peripheral artery disease or PAD).

The main question\[s\] it aims to answer are:

Is the Thor system safe in treating these lesions
Does the Thor system work to treat these lesions

Participants will:

Receive treatment with the Thor system
Have follow-up visits at Discharge, 30 days, 6 months, and 12 months

Conditions

Peripheral Artery Disease

Peripheral Artery Stenosis

Peripheral Artery Calcification

PAD

Study ID

NCT05916950

Start date

Oct 29, 2024

Status verified date

Jun, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

155 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Thor Treatment

Treatment with the Thor system

Interventions

Thor laser atherectomy

Treatment of de novo calcified lesions with laser atherectomy and calcium modification using the Thor system

Primary outcome measure

Freedom from Major Adverse Events (MAEs) [ Time Frame: 30 Days ]
Procedural Success [ Time Frame: At completion of the procedure ]

Central Contacts and Locations

Central contacts

Danielle Op den Kamp

+31 (0)6 27218737 Danielle.op.den.kamp@philips.com

Amanda Franey

763-218-9506 amanda.franey@philips.com

Locations

St. Helena Hospital

Recruiting

St. Helena, California, United States, 94574

Contacts

Jennifer Debattista

DeBattJL@ah.org

Susan Sherman

ShermaSR@ah.org

Principal Investigator:

Leonardo Clavijo, MD

Rocky Mountain Regional VA Medical Center

Recruiting

Aurora, Colorado, United States, 80045

Contacts

David Korb

720.857.5286 david.korb@va.gov

Jennifer Golden

Jennifer.Golden@va.gov

Principal Investigator:

Bilal Aijaz, MD

Manatee Memorial Hospital

Recruiting

Bradenton, Florida, United States, 34205

Contacts

Kanishga Balamurrugarajan

(941) 792-6554 kanishga.balamurrugarajan@novaclinicalresearch.com

Nicolette Weston

nicolette.weston@novaclinicalresearch.com

Principal Investigator:

S. Jay Mathews, MD

Tallahassee Research Institute

Recruiting

Tallahassee, Florida, United States, 32308

Contacts

Kordae Bowden

850-431-5024 Kordae.Bowden@tmh.org

Austin Allen

Austin.allen@tmh.org

Principal Investigator:

Andres Vargas, MD

Guardian Research Organization

Recruiting

Winter Park, Florida, United States, 32792

Contacts

Kathleen Doyle

407-630-9997 kdoyle@guardian-research.com

Principal Investigator:

Ashish Gupta, MD

Vascular Institute of the Midwest

Recruiting

Davenport, Iowa, United States, 52807

Contacts

Lynn Williamson, RN

563-324-3818 lynn.williamson@vimidwest.com

Amy Olsen

amy.olsen@vimidwest.com

Principal Investigator:

Eric Dippel, MD

Cardiovascular Institute of the South

Recruiting

Houma, Louisiana, United States, 70360

Contacts

Darla Patrick

(985) 873-5684 darla.patrick@cardio.com

Deanna Benoit

(985) 873-5613 deanna.benoit@cardio.com

Principal Investigator:

Craig Walker, MD

Cardiovascular Institute of the South

Recruiting

Lafayette, Louisiana, United States, 70503

Contacts

Ariel Quebedeaux

(337) 289-8429 Ariel.Quebedeaux@cardio.com

Principal Investigator:

Ankur Lodha, MD

The Vascular Care Group

Recruiting

Portland, Maine, United States, 04106

Contacts

Emel Ergul

781-304-8838 eergul@vascularbreakthroughs.com

Jennifer Legrand

978-534-3399 jlegrand@vascularcaregrp.com

Principal Investigator:

Nathan Aranson, MD

Southcoast Hospitals/Charlton Memorial Hospital

Recruiting

Fall River, Massachusetts, United States, 02720

Contacts

Debra Benevides

508-973-7775 benevidesd@southcoast.org

Taiwo Esther Kayode

taiwo.e.kayode@southcoast.org

Principal Investigator:

Richard Pin, MD

Vascular Breakthroughs

Recruiting

Leominster, Massachusetts, United States, 04153

Contacts

Maria Myslinski, RN

203-548-7860 mmyslinski@vascularbreakthroughs.com

Elizabeth Gagne, PhD

203-548-7860 egagne@vascularbreakthroughs.com

Principal Investigator:

Stephen Hoenig, MD

Henry Ford St John Hospital

Recruiting

Detroit, Michigan, United States, 22201

Contacts

Renee Bess

313.343.4811 rbess1@hfhs.org

Megan Henkel

mhenkel1@hfhs.org

Principal Investigator:

Thomas Davis, Dr

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Sarah Ackroyd, RN

313-461-4864 sackroy1@hfhs.org

Melanee Schimmel

mschimm2@hfhs.org

Principal Investigator:

Kyle Markel, MD

Deborah Heart and Lung Center

Recruiting

Browns Mills, New Jersey, United States, 08015

Contacts

Janice Prodell

609-893-1200 prodellj@deborah.org

Andrew McElvarr

mcelvarra@deborah.org

Principal Investigator:

Richard Kovach, MD

Heart and Vascular Institute of Central Jersey

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Supraj Amunje

(979) 344-1229 Samunje@orcaresearchgroup.com

Jas

347-944-4694 jkaur@orcaresearchgroup.com

Principal Investigator:

Ramzan Zakir, MD

Atlantic Medical Imaging of New jersey

Recruiting

Vineland, New Jersey, United States, 08360

Contacts

Melisa Rivera

856.362.6056 mrivera@aminj.com

Lenice Valdes

lvaldes@aminj.com

Principal Investigator:

Micah Watts, MD

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Contacts

Chivelle Mendoza

212-241-7052 Chivelle.Mendoza@mountsinai.org

Vanna Nicasio

Vanna.Nicasio@mountsinai.org

Principal Investigator:

Prakash Krishnan, MD

New York Presbyterian Hospital/Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10029

Contacts

Anna Maria Didier

(212) 342-4102 ad4577@cumc.columbia.edu

Claudia Musat

cm2065@cumc.columbia.edu

Principal Investigator:

Virendra Patel, MD

Vascular Solutions of North Carolina

Recruiting

Cary, North Carolina, United States, 27518

Contacts

Swati Gupta

(919) 897-5999 swati@raoclinic.org

Merna Metry

(919) 897-5999 mernam@vascularsolutions.org

Principal Investigator:

Sid Rao, Dr.

Premier Cardiovascular Institute

Recruiting

Fairborn, Ohio, United States, 45324

Contacts

Heather Bell

937.208.6013 hrbell@premierhealth.com

Christina Weller

CWeller@PremierHealth.com

Principal Investigator:

Sagger Mawri, MD

Ascension St. John

Recruiting

Bartlesville, Oklahoma, United States, 74006

Contacts

Mary Harris

mary.harris5@ascension.org

Christina Lester

918.332.3616 christina.lester2@ascension.org

Principal Investigator:

Anderson Merhle, MD

UPMC

Recruiting

Mechanicsburg, Pennsylvania, United States, 17050

Contacts

Laura Wells

717- 920 4402 wellsla2@upmc.edu

Gretchen Meise

717.920.4464 meisegc@upmc.edu

Principal Investigator:

William Bachinsky, Dr

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Alice Chen

215-459-4478 Alice.Chen1@Pennmedicine.upenn.edu

Principal Investigator:

Elizabeth Genovese, MD

Lankenau Institute for Medical Research

Recruiting

Wynnewood, Pennsylvania, United States, 19096

Contacts

Lucy Delp

484.476.8512 delpl@mlhs.org

Lynn Sher

484.476.8581 SherL@mlhs.org

Principal Investigator:

Antonis Pratsos, MD

The Miriam Hospital

Recruiting

Providence, Rhode Island, United States, 02905

Contacts

Lina Felix

407-793-4105 lfelix@lifespan.org

Principal Investigator:

Peter Soukas, MD

Vascular Institute of Chattanooga

Recruiting

Chattanooga, Tennessee, United States, 37421

Contacts

Lacey Weeks

407-793-4105 lweeks@vascularinstituteofchattanooga.com

Principal Investigator:

Chris LeSar, MD

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Emma Bryant

214-648-9449 Emma.Bryant@UTSouthwestern.edu

Jarrett Hubbard

jarrett.hubbard@utsouthwestern.edu

Principal Investigator:

Michael Siah, MD

Baylor, Scott & White, The Heart Hospital

Recruiting

Plano, Texas, United States, 75093

Contacts

Erisa Stokes

469.814.4731 erisa.stokes@BSWHealth.org

Osniel Gonzalez Ramos

206.979.0052 Osniel.GonzalezRamos@BSWHealth.org

Principal Investigator:

Sameh Sayfo, MD

Sentara Health Research Center

Recruiting

Norfolk, Virginia, United States, 23507

Contacts

Sarah Keith

Skescoba@sentara.com

Sarah Havert

sshavert@sentara.com

Principal Investigator:

David Dexter, MD

More Information

Sponsor

Philips Clinical & Medical Affairs Global

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Philips Clinical & Medical Affairs Global on 2026-06-11.