The THOR IDE Study for Peripheral Artery Disease

This study is testing a device called the Thor system to treat blockages in leg arteries caused by peripheral artery disease (PAD). PAD can cause pain in your legs when walking or resting. The Thor system uses a laser to remove calcium from new, untreated blockages in leg arteries. Researchers want to see if the Thor system is safe and effective. You might be able to join if you are at least 18 years old, can walk with or without help, and have PAD with certain symptoms. The study aims to measure how safe the Thor system is after 30 days and if the procedure is successful right away. The current status of the study is unclear, and it plans to enroll 155 participants.

Study design: This is an interventional study, meaning all participants will receive treatment with the Thor system. There is no control group, and it plans to enroll 155 participants.
What's involved: You would have a screening visit, receive treatment with the Thor system, and have follow-up visits at discharge, 30 days, 6 months, and 12 months.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for 12 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

The THOR IDE Study

Recruiting

NAAges 18+InterventionalTreatment

Philips Clinical & Medical Affairs Global

~155 participants

Updated 2026-06-11 on ClinicalTrials.gov

What's tested:Thor laser atherectomy

At a glance

Recruiting sites

29 of 29 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Freedom from Major Adverse Events (MAEs)

Measured over 30 Days

+1 more outcome measured

Conditions

Peripheral Artery Disease

Peripheral Artery Stenosis

Peripheral Artery Calcification

PAD

Where it's being run

29 sites across 18 states

Florida3

New Jersey3

Pennsylvania3

Louisiana2

Massachusetts2

Michigan2

New York2

Texas2

Study leadership

Pradeep Nair, MD · PRINCIPAL_INVESTIGATOR · Cardiovascular Institute of the South (CIS)
Elizabeth Genovese, MD · PRINCIPAL_INVESTIGATOR · University of Pennsylvania

Who to contact

Danielle Op den Kamp

[email protected]

+31 (0)6 27218737

Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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.

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

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.

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.

What this trial measures

Freedom from Major Adverse Events (MAEs)30 Days
Defined as freedom from MAEs including all-cause mortality, clinically driven target lesion revascularization (CD-TLR), unplanned target limb major amputation, perforations, flow-limiting dissections, and symptomatic distal embolizations that require an intervention to resolve
Procedural SuccessAt completion of the procedure
Defined as residual diameter stenosis ≤50% at the end of the procedure as determined by angiographic core lab

Trialytics