Peripheral Artery DiseaseTHORNCT05916950

The THOR IDE Study

A study testing Thor laser atherectomy in people with Peripheral Artery Disease and Peripheral Artery Stenosis, run by Philips Clinical & Medical Affairs Global at 29 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Peripheral Artery Disease, Peripheral Artery Stenosis, Peripheral Artery Calcification
What is being tested?: Thor laser atherectomy
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 155 participants
Where: 29 sitesUnited States
Study dates: 29 Oct 2024to Dec 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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:

Show all 14Show fewer

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

Who cannot join

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

Show all 19Show fewer

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.

Trial locations and contacts

29 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Danielle Op den Kamp contact

+31 (0)6 27218737

Danielle.op.den.kamp@philips.com

Amanda Franey contact

763-218-9506

amanda.franey@philips.com

City, postcode or hospital

Sites recruiting now only

29 sites in 1 country

United States29 sites, 29 recruiting

Rocky Mountain Regional VA Medical Center
Aurora, Colorado, 80045
David Korb, 720.857.5286, david.korb@va.gov
Jennifer Golden, Jennifer.Golden@va.gov
Recruiting
Ascension St. John
Bartlesville, Oklahoma, 74006
Mary Harris, mary.harris5@ascension.org
Christina Lester, 918.332.3616, christina.lester2@ascension.org
Recruiting
Manatee Memorial Hospital
Bradenton, Florida, 34205
Kanishga Balamurrugarajan, (941) 792-6554, kanishga.balamurrugarajan@novaclinicalresearch.com
Nicolette Weston, nicolette.weston@novaclinicalresearch.com
Recruiting
Deborah Heart and Lung Center
Browns Mills, New Jersey, 08015
Janice Prodell, 609-893-1200 ext. 5040, prodellj@deborah.org
Andrew McElvarr, mcelvarra@deborah.org
Recruiting
Vascular Solutions of North Carolina
Cary, North Carolina, 27518
Swati Gupta, (919) 897-5999 ext. 207, swati@raoclinic.org
Merna Metry, (919) 897-5999 ext. 207, mernam@vascularsolutions.org
Recruiting
Vascular Institute of Chattanooga
Chattanooga, Tennessee, 37421
Lacey Weeks, 407-793-4105, lweeks@vascularinstituteofchattanooga.com
Chris LeSar, MD
Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Emma Bryant, 214-648-9449, Emma.Bryant@UTSouthwestern.edu
Jarrett Hubbard, jarrett.hubbard@utsouthwestern.edu
Recruiting
Vascular Institute of the Midwest
Davenport, Iowa, 52807
Lynn Williamson, RN, 563-324-3818 ext. 1, lynn.williamson@vimidwest.com
Amy Olsen, amy.olsen@vimidwest.com
Recruiting
Henry Ford St John Hospital
Detroit, Michigan, 22201
Renee Bess, 313.343.4811, rbess1@hfhs.org
Megan Henkel, mhenkel1@hfhs.org
Recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
Sarah Ackroyd, RN, 313-461-4864, sackroy1@hfhs.org
Melanee Schimmel, mschimm2@hfhs.org
Recruiting
Premier Cardiovascular Institute
Fairborn, Ohio, 45324
Heather Bell, 937.208.6013, hrbell@premierhealth.com
Christina Weller, CWeller@PremierHealth.com
Recruiting
Southcoast Hospitals/Charlton Memorial Hospital
Fall River, Massachusetts, 02720
Debra Benevides, 508-973-7775, benevidesd@southcoast.org
Taiwo Esther Kayode, taiwo.e.kayode@southcoast.org
Recruiting
Cardiovascular Institute of the South
Houma, Louisiana, 70360
Darla Patrick, (985) 873-5684 ext. 5684, darla.patrick@cardio.com
Deanna Benoit, (985) 873-5613, deanna.benoit@cardio.com
Recruiting
Cardiovascular Institute of the South
Lafayette, Louisiana, 70503
Ariel Quebedeaux, (337) 289-8429 ext. 3545, Ariel.Quebedeaux@cardio.com
Ankur Lodha, MD
Recruiting
Vascular Breakthroughs
Leominster, Massachusetts, 04153
Maria Myslinski, RN, 203-548-7860 ext. 998, mmyslinski@vascularbreakthroughs.com
Elizabeth Gagne, PhD, 203-548-7860 ext. 999, egagne@vascularbreakthroughs.com
Recruiting
UPMC
Mechanicsburg, Pennsylvania, 17050
Laura Wells, 717- 920 4402, wellsla2@upmc.edu
Gretchen Meise, 717.920.4464, meisegc@upmc.edu
Recruiting
Heart and Vascular Institute of Central Jersey
New Brunswick, New Jersey, 08901
Supraj Amunje, (979) 344-1229, Samunje@orcaresearchgroup.com
Jas, 347-944-4694, jkaur@orcaresearchgroup.com
Recruiting
Mount Sinai Hospital
New York, New York, 10029
Chivelle Mendoza, 212-241-7052, Chivelle.Mendoza@mountsinai.org
Vanna Nicasio, Vanna.Nicasio@mountsinai.org
Recruiting
New York Presbyterian Hospital/Columbia University Irving Medical Center
New York, New York, 10029
Anna Maria Didier, (212) 342-4102, ad4577@cumc.columbia.edu
Claudia Musat, cm2065@cumc.columbia.edu
Recruiting
Sentara Health Research Center
Norfolk, Virginia, 23507
Sarah Keith, Skescoba@sentara.com
Sarah Havert, sshavert@sentara.com
Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Alice Chen, 215-459-4478, Alice.Chen1@Pennmedicine.upenn.edu
Elizabeth Genovese, MD
Recruiting
Baylor, Scott & White, The Heart Hospital
Plano, Texas, 75093
Erisa Stokes, 469.814.4731, erisa.stokes@BSWHealth.org
Osniel Gonzalez Ramos, 206.979.0052, Osniel.GonzalezRamos@BSWHealth.org
Recruiting
The Vascular Care Group
Portland, Maine, 04106
Emel Ergul, 781-304-8838, eergul@vascularbreakthroughs.com
Jennifer Legrand, 978-534-3399 ext. 217, jlegrand@vascularcaregrp.com
Recruiting
The Miriam Hospital
Providence, Rhode Island, 02905
Lina Felix, 407-793-4105, lfelix@lifespan.org
Peter Soukas, MD
Recruiting
St. Helena Hospital
St. Helena, California, 94574
Jennifer Debattista, DeBattJL@ah.org
Susan Sherman, ShermaSR@ah.org
Recruiting
Tallahassee Research Institute
Tallahassee, Florida, 32308
Kordae Bowden, 850-431-5024, Kordae.Bowden@tmh.org
Austin Allen, Austin.allen@tmh.org
Recruiting
Atlantic Medical Imaging of New jersey
Vineland, New Jersey, 08360
Melisa Rivera, 856.362.6056 ext. 3571, mrivera@aminj.com
Lenice Valdes, lvaldes@aminj.com
Recruiting
Guardian Research Organization
Winter Park, Florida, 32792
Kathleen Doyle, 407-630-9997, kdoyle@guardian-research.com
Tiffany King
Recruiting
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, 19096
Lucy Delp, 484.476.8512, delpl@mlhs.org
Lynn Sher, 484.476.8581, SherL@mlhs.org
Recruiting

Other trials in United States

About this study

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

Read the detailed description

Up to 30 sites in the U.S. will be selected to do this study.

Patients with pain in their legs when walking and/or resting that is due to lack of blood flow to their legs may be able to join the study. To join the study patients must also have blockages in their leg arteries that meet the study criteria.

Before the Thor procedure, patients will have a screening visit that includes a review of their medical records, questions about their medical history and medications taken for blood thinning or circulation, a physical examination of their legs, a test to check the blood flow in their legs (by checking arm and leg blood pressures), blood tests, and a pregnancy test if they are a female able to have children. Patients will also answer questions about any trouble they have had with walking in the last week and their overall quality of life.

All patients in the study will have treatment with the Thor system. There is no "control group" (a group of patients that receives only standard treatment or receives no treatment at all) in this study. During the procedure, the doctor will take x-ray pictures of the leg arteries. They may also use other treatments such as angioplasty balloons, drug-coated balloons, stents, and filters that collect blood clots, if needed.

Patients treated with the Thor system will be watched until they are ready to go home or up to 24 hours after the procedure if they do not go home right away. Before they go home they will have a test to check the blood flow to their legs (by checking arm and leg blood pressures) and be checked for any adverse events.

Patients will return for visits at 30 days, 6 months, and 12 months after the Thor procedure. At these visits patients will be asked questions about their medical history and medications taken for blood thinning or circulation, have a physical examination of their legs, have a test to check the blood flow in their treated leg (by checking arm and leg blood pressures), have an ultrasound of their treated leg, and be checked for any adverse events. Patients will also answer questions about any trouble they have had with walking in the last week and their overall quality of life.

It will take up to 24 months (2 years) to enroll all of the patients in the study. Patients who join the study will be in the study for about 12 months (1 year) and will have all of the visits with their doctor that they would normally have for their PAD.

Conditions: Peripheral Artery Disease, Peripheral Artery Stenosis, Peripheral Artery Calcification, PAD
Being tested: Thor laser atherectomy
Medical subject headings: Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05916950
Study group	Role	What they receive
Thor Treatment	Experimental	Treatment with the Thor system Receives: Device: Thor laser atherectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 30 Days
Procedural Success
Defined as residual diameter stenosis ≤50% at the end of the procedure as determined by angiographic core lab
Measured: At completion of the procedure

Secondary outcomes (21)

Target lesion patency, 30 days
Defined as freedom from CD-TLR and freedom from ≥50% restenosis as determined by duplex ultrasound (DUS) or angiogram
Measured: 30 days
Target lesion patency, 6 months
Defined as freedom from CD-TLR and freedom from ≥50% restenosis as determined by duplex ultrasound (DUS) or angiogram
Measured: 6 months
Target lesion patency, 12 months
Defined as freedom from CD-TLR and freedom from ≥50% restenosis as determined by duplex ultrasound (DUS) or angiogram
Measured: 12 months
Clinically-driven target lesion revascularization
Defined as repeat revascularization procedure of the target lesion if PSVR is ≥2.5 by DUS or if angiography shows a percent diameter stenosis >50% and there are worsening clinical symptoms, worsening Rutherford Clinical Category or ABI that is clearly referable to the target lesion.
Measured: Through 12 months
Technical success
Defined as the ability to deliver the Thor system and achieve residual diameter stenosis ≤50% after treatment with Thor and prior to adjunctive PTA, as confirmed by independent core laboratory assessments of angiographic images
Measured: Peri-procedural
Frequency of peri-procedural adverse events
Defined as frequency of adverse events related to the investigational device (Thor system)
Measured: Within 24 hours of the procedure
Adjunctive devices used with the Thor system
Defined as the use of other devices including angioplasty balloons, drug coated balloons, bailout stents, embolic filters
Measured: Peri-procedural
Target Limb Ankle-Brachial Index (ABI) change, Discharge
Defined as the change in blood pressure in the upper limb (arm) and lower limb (leg or toes) at discharge compared to the baseline (Screening) value
Measured: Discharge or up to 24 hours after the procedure
Target Limb Ankle-Brachial Index (ABI) change, 30 days
Defined as the change in blood pressure in the upper limb (arm) and lower limb (leg or toes) at 30 days compared to the baseline (Screening) value
Measured: 30 days
Target Limb Ankle-Brachial Index (ABI) change, 6 months
Defined as the change in blood pressure in the upper limb (arm) and lower limb (leg or toes) at 6 months compared to the baseline (Screening) value
Measured: 6 months
Target Limb Ankle-Brachial Index (ABI) change, 12 months
Defined as the change in blood pressure in the upper limb (arm) and lower limb (leg or toes) at 12 months compared to the baseline (Screening) value
Measured: 12 months
Rutherford Classification change, 30 days
Defined as the change in Rutherford classification at 30 days compared to the baseline (Screening) value. Rutherford Classification is a staging system to describe reduced blood flow in the lower limb. Rutherford Classifications values range from the least severe (asymptomatic) which is scored a 0 to the most severe (ulceration or gangrene) which is scored a 6.
Measured: 30 days
Rutherford Classification change, 6 months
Defined as the change in Rutherford classification at 6 months compared to the baseline (Screening) value. Rutherford Classification is a staging system to describe reduced blood flow in the lower limb. Rutherford Classifications values range from the least severe (asymptomatic) which is scored a 0 to the most severe (ulceration or gangrene) which is scored a 6.
Measured: 6 months
Rutherford Classification change, 12 months
Defined as the change in Rutherford classification at 12 months compared to the baseline (Screening) value. Rutherford Classification is a staging system to describe reduced blood flow in the lower limb. Rutherford Classifications values range from the least severe (asymptomatic) which is scored a 0 to the most severe (ulceration or gangrene) which is scored a 6.
Measured: 12 months
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, and perforations, flow-limiting dissections, and symptomatic distal embolizations that require an intervention to resolve
Measured: Through 12 months
Change in Short Form Health Survey (SF-36) score, 30 days
Defined as the change in SF-36 score at 30 days compared to the baseline (Screening) value. The SF-36 is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: 30 days
Change in Short Form Health Survey (SF-36) score, 6 months
Defined as the change in SF-36 score at 6 months compared to the baseline (Screening) value. The SF-36 is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: 6 months
Change in Short Form Health Survey (SF-36) score, 12 months
Defined as the change in SF-36 score at 12 months compared to the baseline (Screening) value. The SF-36 is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: 12 months
Change in Walking Impairment Questionnaire (WIQ) score, 30 days
Defined as the change in WIQ score at 30 days compared to the baseline (Screening) value. The WIQ measures self-reported walking impairment, walking distance, walking speed, and stair-climbing ability. In the WIQ there are 21 questions to rate the degree of difficulty with the walking and stair climbing elements. The response for each question is on a 0 to 4 scale, where 0 represents the inability to walk or climb stairs, and 4 represents no difficulty.
Measured: 30 days
Change in Walking Impairment Questionnaire (WIQ) score, 6 months
Defined as the change in WIQ score at 6 months compared to the baseline (Screening) value. The WIQ measures self-reported walking impairment, walking distance, walking speed, and stair-climbing ability. In the WIQ there are 21 questions to rate the degree of difficulty with the walking and stair climbing elements. The response for each question is on a 0 to 4 scale, where 0 represents the inability to walk or climb stairs, and 4 represents no difficulty.
Measured: 6 months
Change in Walking Impairment Questionnaire (WIQ) score, 12 months
Defined as the change in WIQ score at 12 months compared to the baseline (Screening) value. The WIQ measures self-reported walking impairment, walking distance, walking speed, and stair-climbing ability. In the WIQ there are 21 questions to rate the degree of difficulty with the walking and stair climbing elements. The response for each question is on a 0 to 4 scale, where 0 represents the inability to walk or climb stairs, and 4 represents no difficulty.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Oct 2024Dec 2027

First posted23 Jun 2023
Study start29 Oct 2024
Primary completionDec 2026 (estimated)
Study completionDec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (49)Papers the sponsor has linked to this study.
Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Prospective, single-arm, multicenter, and open-label study
Masking: None (open label)
Enrolment: 155 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05916950
Sponsor's protocol ID: 200201
Acronym: THOR
Status last verified: Jun 2026
First submitted: 7 Jun 2023
Last updated: 11 Jun 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASC II Working Group; Bell K, Caporusso J, Durand-Zaleski I, Komori K, Lammer J, Liapis C, Novo S, Razavi M, Robbs J, Schaper N, Shigematsu H, Sapoval M, White C, White J, Clement D, Creager M, Jaff M, Mohler E 3rd, Rutherford RB, Sheehan P, Sillesen H, Rosenfield K. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Eur J Vasc Endovasc Surg. 2007;33 Suppl 1:S1-75. doi: 10.1016/j.ejvs.2006.09.024. Epub 2006 Nov 29. No abstract available.
PubMed 17140820
Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL, Hiratzka LF, Murphy WR, Olin JW, Puschett JB, Rosenfield KA, Sacks D, Stanley JC, Taylor LM Jr, White CJ, White J, White RA, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Gibbons RJ, Hunt SA, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American Association for Vascular Surgery; Society for Vascular Surgery; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology; Society of Interventional Radiology; ACC/AHA Task Force on Practice Guidelines Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease; American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; Vascular Disease Foundation. ACC/AHA 2005 Practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease): endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. Circulation. 2006 Mar 21;113(11):e463-654. doi: 10.1161/CIRCULATIONAHA.106.174526. No abstract available.
PubMed 16549646
Hirsch AT, Criqui MH, Treat-Jacobson D, Regensteiner JG, Creager MA, Olin JW, Krook SH, Hunninghake DB, Comerota AJ, Walsh ME, McDermott MM, Hiatt WR. Peripheral arterial disease detection, awareness, and treatment in primary care. JAMA. 2001 Sep 19;286(11):1317-24. doi: 10.1001/jama.286.11.1317.
PubMed 11560536
Mueller T, Hinterreiter F, Poelz W, Haltmayer M, Dieplinger B. Mortality rates at 10 years are higher in diabetic than in non-diabetic patients with chronic lower extremity peripheral arterial disease. Vasc Med. 2016 Oct;21(5):445-452. doi: 10.1177/1358863X16643603. Epub 2016 Apr 11.
PubMed 27067137
Caro J, Migliaccio-Walle K, Ishak KJ, Proskorovsky I. The morbidity and mortality following a diagnosis of peripheral arterial disease: long-term follow-up of a large database. BMC Cardiovasc Disord. 2005 Jun 22;5:14. doi: 10.1186/1471-2261-5-14.
PubMed 15972099
Dieter RS, Chu WW, Pacanowski JP Jr, McBride PE, Tanke TE. The significance of lower extremity peripheral arterial disease. Clin Cardiol. 2002 Jan;25(1):3-10. doi: 10.1002/clc.4950250103.
PubMed 11808837
Guez D, Hansberry DR, Gonsalves CF, Eschelman DJ, Parker L, Rao VM, Levin DC. Recent Trends in Endovascular and Surgical Treatment of Peripheral Arterial Disease in the Medicare Population. AJR Am J Roentgenol. 2020 May;214(5):962-966. doi: 10.2214/AJR.19.21967. Epub 2020 Feb 25.
PubMed 32097027
Rocha-Singh KJ, Jaff MR, Crabtree TR, Bloch DA, Ansel G; VIVA Physicians, Inc. Performance goals and endpoint assessments for clinical trials of femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease. Catheter Cardiovasc Interv. 2007 May 1;69(6):910-9. doi: 10.1002/ccd.21104.
PubMed 17377972
Minar E, Pokrajac B, Maca T, Ahmadi R, Fellner C, Mittlbock M, Seitz W, Wolfram R, Potter R. Endovascular brachytherapy for prophylaxis of restenosis after femoropopliteal angioplasty : results of a prospective randomized study. Circulation. 2000 Nov 28;102(22):2694-9. doi: 10.1161/01.cir.102.22.2694.
PubMed 11094034
van der Zaag ES, Legemate DA, Prins MH, Reekers JA, Jacobs MJ. Angioplasty or bypass for superficial femoral artery disease? A randomised controlled trial. Eur J Vasc Endovasc Surg. 2004 Aug;28(2):132-7. doi: 10.1016/j.ejvs.2004.04.003.
PubMed 15234692
Schillinger M, Sabeti S, Loewe C, Dick P, Amighi J, Mlekusch W, Schlager O, Cejna M, Lammer J, Minar E. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med. 2006 May 4;354(18):1879-88. doi: 10.1056/NEJMoa051303.
PubMed 16672699
Pokrajac B, Potter R, Wolfram RM, Budinsky AC, Kirisits C, Lileg B, Mendel H, Sabeti S, Schmid R, Minar E. Endovascular brachytherapy prevents restenosis after femoropopliteal angioplasty: results of the Vienna-3 randomised multicenter study. Radiother Oncol. 2005 Jan;74(1):3-9. doi: 10.1016/j.radonc.2004.08.015.
PubMed 15683661
Krankenberg H, Schluter M, Steinkamp HJ, Burgelin K, Scheinert D, Schulte KL, Minar E, Peeters P, Bosiers M, Tepe G, Reimers B, Mahler F, Tubler T, Zeller T. Nitinol stent implantation versus percutaneous transluminal angioplasty in superficial femoral artery lesions up to 10 cm in length: the femoral artery stenting trial (FAST). Circulation. 2007 Jul 17;116(3):285-92. doi: 10.1161/CIRCULATIONAHA.107.689141. Epub 2007 Jun 25.
PubMed 17592075
Sabeti S, Schillinger M, Amighi J, Sherif C, Mlekusch W, Ahmadi R, Minar E. Primary patency of femoropopliteal arteries treated with nitinol versus stainless steel self-expanding stents: propensity score-adjusted analysis. Radiology. 2004 Aug;232(2):516-21. doi: 10.1148/radiol.2322031345.
PubMed 15286322
Ferreira M, Lanziotti L, Monteiro M, Abuhadba G, Capotorto LF, Nolte L, Fearnot N. Superficial femoral artery recanalization with self-expanding nitinol stents: long-term follow-up results. Eur J Vasc Endovasc Surg. 2007 Dec;34(6):702-8. doi: 10.1016/j.ejvs.2007.07.025. Epub 2007 Oct 24.
PubMed 17920306

Interested in taking part?

Danielle Op den Kamp

+31 (0)6 27218737

Danielle.op.den.kamp@philips.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Active, not recruiting
Preventing Kidney Injury Using Carbon Dioxide as Contrast Medium in Patients With Peripheral Arterial Disease (PAD) and Chronic Kidney Disease (CKD) Having Arterial Intervention
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Recruiting
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
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All Peripheral Artery Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The THOR IDE Study
ClinicalTrials.gov ID: NCT05916950
Acronym / sponsor ID: THOR / 200201
Conditions: Peripheral Artery Disease, Peripheral Artery Stenosis, Peripheral Artery Calcification, PAD
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 155 participants (estimated)
Lead sponsor: Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
Collaborators: NAMSA, Syntropic Corelab
Study start: 29 Oct 2024 (actual)
Primary completion: Dec 2026 (estimated)
Study completion: Dec 2027 (estimated)
First posted: 23 Jun 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Up to 30 sites in the U.S. will be selected to do this study.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Prospective, single-arm, multicenter, and open-label study

Arm	Type	Receives
Thor Treatment	Experimental	Device: Thor laser atherectomyTreatment with the Thor system

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

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.

Key exclusion criteria (19 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Thor laser atherectomyAlso: Thor calcium modificationTreatment of de novo calcified lesions with laser atherectomy and calcium modification using the Thor system	Device	Thor Treatment

Primary outcome

Freedom from Major Adverse Events (MAEs)
Time frame: 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 Success
Time frame: At completion of the procedure
Defined as residual diameter stenosis ≤50% at the end of the procedure as determined by angiographic core lab

21 secondary outcomes

Target lesion patency, 30 days
Time frame: 30 days
Target lesion patency, 6 months
Time frame: 6 months
Target lesion patency, 12 months
Time frame: 12 months
Clinically-driven target lesion revascularization
Time frame: Through 12 months
Technical success
Time frame: Peri-procedural
Frequency of peri-procedural adverse events
Time frame: Within 24 hours of the procedure
Adjunctive devices used with the Thor system
Time frame: Peri-procedural
Target Limb Ankle-Brachial Index (ABI) change, Discharge
Time frame: Discharge or up to 24 hours after the procedure
Target Limb Ankle-Brachial Index (ABI) change, 30 days
Time frame: 30 days
Target Limb Ankle-Brachial Index (ABI) change, 6 months
Time frame: 6 months
Target Limb Ankle-Brachial Index (ABI) change, 12 months
Time frame: 12 months
Rutherford Classification change, 30 days
Time frame: 30 days
Rutherford Classification change, 6 months
Time frame: 6 months
Rutherford Classification change, 12 months
Time frame: 12 months
Freedom from Major Adverse Events (MAEs)
Time frame: Through 12 months
Change in Short Form Health Survey (SF-36) score, 30 days
Time frame: 30 days
Change in Short Form Health Survey (SF-36) score, 6 months
Time frame: 6 months
Change in Short Form Health Survey (SF-36) score, 12 months
Time frame: 12 months
Change in Walking Impairment Questionnaire (WIQ) score, 30 days
Time frame: 30 days
Change in Walking Impairment Questionnaire (WIQ) score, 6 months
Time frame: 6 months
Change in Walking Impairment Questionnaire (WIQ) score, 12 months
Time frame: 12 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
Background: PubMed 17140820Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASC II Working Group; Bell K, Caporusso J, Durand-Zaleski I, Komori K, Lammer J, Liapis C, Novo S, Razavi M, Robbs J, Schaper N, Shigematsu H, Sapoval M, White C, White J, Clement D, Creager M, Jaff M, Mohler E 3rd, Rutherford RB, Sheehan P, Sillesen H, Rosenfield K. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Eur J Vasc Endovasc Surg. 2007;33 Suppl 1:S1-75. doi: 10.1016/j.ejvs.2006.09.024. Epub 2006 Nov 29. No abstract available.
Background: PubMed 16549646Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL, Hiratzka LF, Murphy WR, Olin JW, Puschett JB, Rosenfield KA, Sacks D, Stanley JC, Taylor LM Jr, White CJ, White J, White RA, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Gibbons RJ, Hunt SA, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American Association for Vascular Surgery; Society for Vascular Surgery; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology; Society of Interventional Radiology; ACC/AHA Task Force on Practice Guidelines Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease; American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; Vascular Disease Foundation. ACC/AHA 2005 Practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease): endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. Circulation. 2006 Mar 21;113(11):e463-654. doi: 10.1161/CIRCULATIONAHA.106.174526. No abstract available.
Background: PubMed 11560536Hirsch AT, Criqui MH, Treat-Jacobson D, Regensteiner JG, Creager MA, Olin JW, Krook SH, Hunninghake DB, Comerota AJ, Walsh ME, McDermott MM, Hiatt WR. Peripheral arterial disease detection, awareness, and treatment in primary care. JAMA. 2001 Sep 19;286(11):1317-24. doi: 10.1001/jama.286.11.1317.
Background: PubMed 27067137Mueller T, Hinterreiter F, Poelz W, Haltmayer M, Dieplinger B. Mortality rates at 10 years are higher in diabetic than in non-diabetic patients with chronic lower extremity peripheral arterial disease. Vasc Med. 2016 Oct;21(5):445-452. doi: 10.1177/1358863X16643603. Epub 2016 Apr 11.
Background: PubMed 15972099Caro J, Migliaccio-Walle K, Ishak KJ, Proskorovsky I. The morbidity and mortality following a diagnosis of peripheral arterial disease: long-term follow-up of a large database. BMC Cardiovasc Disord. 2005 Jun 22;5:14. doi: 10.1186/1471-2261-5-14.
Background: PubMed 11808837Dieter RS, Chu WW, Pacanowski JP Jr, McBride PE, Tanke TE. The significance of lower extremity peripheral arterial disease. Clin Cardiol. 2002 Jan;25(1):3-10. doi: 10.1002/clc.4950250103.
Background: PubMed 32097027Guez D, Hansberry DR, Gonsalves CF, Eschelman DJ, Parker L, Rao VM, Levin DC. Recent Trends in Endovascular and Surgical Treatment of Peripheral Arterial Disease in the Medicare Population. AJR Am J Roentgenol. 2020 May;214(5):962-966. doi: 10.2214/AJR.19.21967. Epub 2020 Feb 25.
Background: PubMed 17377972Rocha-Singh KJ, Jaff MR, Crabtree TR, Bloch DA, Ansel G; VIVA Physicians, Inc. Performance goals and endpoint assessments for clinical trials of femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease. Catheter Cardiovasc Interv. 2007 May 1;69(6):910-9. doi: 10.1002/ccd.21104.
Background: PubMed 11094034Minar E, Pokrajac B, Maca T, Ahmadi R, Fellner C, Mittlbock M, Seitz W, Wolfram R, Potter R. Endovascular brachytherapy for prophylaxis of restenosis after femoropopliteal angioplasty : results of a prospective randomized study. Circulation. 2000 Nov 28;102(22):2694-9. doi: 10.1161/01.cir.102.22.2694.
Background: PubMed 15234692van der Zaag ES, Legemate DA, Prins MH, Reekers JA, Jacobs MJ. Angioplasty or bypass for superficial femoral artery disease? A randomised controlled trial. Eur J Vasc Endovasc Surg. 2004 Aug;28(2):132-7. doi: 10.1016/j.ejvs.2004.04.003.
Background: PubMed 16672699Schillinger M, Sabeti S, Loewe C, Dick P, Amighi J, Mlekusch W, Schlager O, Cejna M, Lammer J, Minar E. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med. 2006 May 4;354(18):1879-88. doi: 10.1056/NEJMoa051303.
Background: PubMed 15683661Pokrajac B, Potter R, Wolfram RM, Budinsky AC, Kirisits C, Lileg B, Mendel H, Sabeti S, Schmid R, Minar E. Endovascular brachytherapy prevents restenosis after femoropopliteal angioplasty: results of the Vienna-3 randomised multicenter study. Radiother Oncol. 2005 Jan;74(1):3-9. doi: 10.1016/j.radonc.2004.08.015.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Danielle Op den Kamp contact

+31 (0)6 27218737

Danielle.op.den.kamp@philips.com

Amanda Franey contact

763-218-9506

amanda.franey@philips.com

Pradeep Nair, MD principal investigator

Cardiovascular Institute of the South (CIS)

Elizabeth Genovese, MD principal investigator

University of Pennsylvania

29 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Thor laser atherectomy in people with Peripheral Artery Disease and Peripheral Artery Stenosis, run by Philips Clinical & Medical Affairs Global at 29 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Danielle Op den Kamp (+31 (0)6 27218737, Danielle.op.den.kamp@philips.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom from Major Adverse Events (MAEs) (time frame: 30 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05916950, which also lists 49 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.