The THOR IDE Study

NCT05916950 | Recruiting DMC FDA Device

• 1 other identifier: 200201
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 29

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 Stenosis; Peripheral Artery Calcification; PAD; Peripheral Artery Disease

Outcome Measures

Primary Outcomes (2)

• Freedom from Major Adverse Events (MAEs)

  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

  30 Days

• Procedural Success

  Defined as residual diameter stenosis ≤50% at the end of the procedure as determined by angiographic core lab

  At completion of the procedure

Secondary Outcomes (21)

• Target lesion patency, 30 days

  30 days

• Target lesion patency, 6 months

  6 months

• Target lesion patency, 12 months

  12 months

• Clinically-driven target lesion revascularization

  Through 12 months

• Technical success

  Peri-procedural

Study Arms (1)

Thor Treatment

EXPERIMENTAL

Treatment with the Thor system

Device: Thor laser atherectomy

Interventions

Thor laser atherectomy DEVICE

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

Also known as: Thor calcium modification

Thor Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NAMSA: collaborator
• Syntropic Corelab: collaborator
• Philips Clinical & Medical Affairs Global: lead

Study Sites (29)

St. Helena Hospital

St. Helena, California, 94574, United States

RECRUITING

Rocky Mountain Regional VA Medical Center

Aurora, Colorado, 80045, United States

RECRUITING

Manatee Memorial Hospital

Bradenton, Florida, 34205, United States

RECRUITING

Tallahassee Research Institute

Tallahassee, Florida, 32308, United States

RECRUITING

Guardian Research Organization

Winter Park, Florida, 32792, United States

RECRUITING

Vascular Institute of the Midwest

Davenport, Iowa, 52807, United States

RECRUITING

Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

RECRUITING

Cardiovascular Institute of the South

Lafayette, Louisiana, 70503, United States

RECRUITING

The Vascular Care Group

Portland, Maine, 04106, United States

RECRUITING

Southcoast Hospitals/Charlton Memorial Hospital

Fall River, Massachusetts, 02720, United States

RECRUITING

Vascular Breakthroughs

Leominster, Massachusetts, 04153, United States

RECRUITING

Henry Ford St John Hospital

Detroit, Michigan, 22201, United States

RECRUITING

Henry Ford Hospital

Detroit, Michigan, 48202, United States

RECRUITING

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States

RECRUITING

Heart and Vascular Institute of Central Jersey

New Brunswick, New Jersey, 08901, United States

RECRUITING

Atlantic Medical Imaging of New jersey

Vineland, New Jersey, 08360, United States

RECRUITING

Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

New York Presbyterian Hospital/Columbia University Irving Medical Center

New York, New York, 10029, United States

RECRUITING

Vascular Solutions of North Carolina

Cary, North Carolina, 27518, United States

RECRUITING

Premier Cardiovascular Institute

Fairborn, Ohio, 45324, United States

RECRUITING

Ascension St. John

Bartlesville, Oklahoma, 74006, United States

RECRUITING

UPMC

Mechanicsburg, Pennsylvania, 17050, United States

RECRUITING

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Lankenau Institute for Medical Research

Wynnewood, Pennsylvania, 19096, United States

RECRUITING

The Miriam Hospital

Providence, Rhode Island, 02905, United States

RECRUITING

Vascular Institute of Chattanooga

Chattanooga, Tennessee, 37421, United States

RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Baylor, Scott & White, The Heart Hospital

Plano, Texas, 75093, United States

RECRUITING

Sentara Health Research Center

Norfolk, Virginia, 23507, United States

RECRUITING

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MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Pradeep Nair, MD

  Cardiovascular Institute of the South (CIS)

  PRINCIPAL INVESTIGATOR

• Elizabeth Genovese, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danielle Op den Kamp

CONTACT

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

Clarice Scofield

CONTACT

612.803.9461; clarice.scofield@philips.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, single-arm, multicenter, and open-label study

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: June 23, 2023
• Study Start: October 29, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (29)