Recruiting

The THOR IDE Study

Philips Clinical & Medical Affairs Global · with NAMSA, Syntropic Corelab · NCT05916950

Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation: Not posted. Ask the study team before screening.
Who can join: Ages 18+ · All sexes
Healthy volunteers: Not accepted (a condition is required)
Study type: Interventional · Not applicable
Target enrollment: 155
US sites recruiting: 29
Study start: October 29, 2024
Record last updated: June 11, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: Thor laser atherectomy

Conditions: Peripheral Artery Disease; Peripheral Artery Stenosis; Peripheral Artery Calcification; PAD

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

St. Helena Hospital
St. Helena, CA 94574
Site contact: Jennifer Debattista · DeBattJL@ah.org
Rocky Mountain Regional VA Medical Center
Aurora, CO 80045
Site contact: David Korb · 720.857.5286 · david.korb@va.gov
Manatee Memorial Hospital
Bradenton, FL 34205
Site contact: Kanishga Balamurrugarajan · (941) 792-6554 · kanishga.balamurrugarajan@novaclinicalresearch.com
Tallahassee Research Institute
Tallahassee, FL 32308
Site contact: Kordae Bowden · 850-431-5024 · Kordae.Bowden@tmh.org
Guardian Research Organization
Winter Park, FL 32792
Site contact: Kathleen Doyle · 407-630-9997 · kdoyle@guardian-research.com
Vascular Institute of the Midwest
Davenport, IA 52807
Site contact: Lynn Williamson, RN · 563-324-3818 · lynn.williamson@vimidwest.com
Cardiovascular Institute of the South
Houma, LA 70360
Site contact: Darla Patrick · (985) 873-5684 · darla.patrick@cardio.com
Cardiovascular Institute of the South
Lafayette, LA 70503
Site contact: Ariel Quebedeaux · (337) 289-8429 · Ariel.Quebedeaux@cardio.com
The Vascular Care Group
Portland, ME 04106
Site contact: Emel Ergul · 781-304-8838 · eergul@vascularbreakthroughs.com
Southcoast Hospitals/Charlton Memorial Hospital
Fall River, MA 02720
Site contact: Debra Benevides · 508-973-7775 · benevidesd@southcoast.org
Vascular Breakthroughs
Leominster, MA 04153
Site contact: Maria Myslinski, RN · 203-548-7860 · mmyslinski@vascularbreakthroughs.com
Henry Ford St John Hospital
Detroit, MI 22201
Site contact: Renee Bess · 313.343.4811 · rbess1@hfhs.org
Henry Ford Hospital
Detroit, MI 48202
Site contact: Sarah Ackroyd, RN · 313-461-4864 · sackroy1@hfhs.org
Deborah Heart and Lung Center
Browns Mills, NJ 08015
Site contact: Janice Prodell · 609-893-1200 · prodellj@deborah.org
Heart and Vascular Institute of Central Jersey
New Brunswick, NJ 08901
Site contact: Supraj Amunje · (979) 344-1229 · Samunje@orcaresearchgroup.com
Atlantic Medical Imaging of New jersey
Vineland, NJ 08360
Site contact: Melisa Rivera · 856.362.6056 · mrivera@aminj.com
Mount Sinai Hospital
New York, NY 10029
Site contact: Chivelle Mendoza · 212-241-7052 · Chivelle.Mendoza@mountsinai.org
New York Presbyterian Hospital/Columbia University Irving Medical Center
New York, NY 10029
Site contact: Anna Maria Didier · (212) 342-4102 · ad4577@cumc.columbia.edu
Vascular Solutions of North Carolina
Cary, NC 27518
Site contact: Swati Gupta · (919) 897-5999 · swati@raoclinic.org
Premier Cardiovascular Institute
Fairborn, OH 45324
Site contact: Heather Bell · 937.208.6013 · hrbell@premierhealth.com
Ascension St. John
Bartlesville, OK 74006
Site contact: Mary Harris · mary.harris5@ascension.org
UPMC
Mechanicsburg, PA 17050
Site contact: Laura Wells · 717- 920 4402 · wellsla2@upmc.edu
Hospital of the University of Pennsylvania
Philadelphia, PA 19104
Site contact: Alice Chen · 215-459-4478 · Alice.Chen1@Pennmedicine.upenn.edu
Lankenau Institute for Medical Research
Wynnewood, PA 19096
Site contact: Lucy Delp · 484.476.8512 · delpl@mlhs.org
The Miriam Hospital
Providence, RI 02905
Site contact: Lina Felix · 407-793-4105 · lfelix@lifespan.org
Vascular Institute of Chattanooga
Chattanooga, TN 37421
Site contact: Lacey Weeks · 407-793-4105 · lweeks@vascularinstituteofchattanooga.com
University of Texas Southwestern Medical Center
Dallas, TX 75390
Site contact: Emma Bryant · 214-648-9449 · Emma.Bryant@UTSouthwestern.edu
Baylor, Scott & White, The Heart Hospital
Plano, TX 75093
Site contact: Erisa Stokes · 469.814.4731 · erisa.stokes@BSWHealth.org
Sentara Health Research Center
Norfolk, VA 23507
Site contact: Sarah Keith · Skescoba@sentara.com

Study contacts (from the official record)

Danielle Op den Kamp · +31 (0)6 27218737 · Danielle.op.den.kamp@philips.com
Amanda Franey · 763-218-9506 · amanda.franey@philips.com