Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II).
L Norgren, W R Hiatt, J A Dormandy...
https://pubmed.ncbi.nlm.nih.gov/17140820Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05916950
The THOR IDE Study for Treating Calcified Lesions in Leg Arteries Using the Thor Laser Atherectomy System
Led by Philips Clinical & Medical Affairs Global · Updated on 2026-03-20
155
Participants Needed
29
Research Sites
52 weeks
Total Duration
On this page
Sponsors
P
Philips Clinical & Medical Affairs Global
Lead Sponsor
N
NAMSA
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the Thor system in adults aged 18 years and older who have new, untreated calcified blockages in the arteries of their legs caused by peripheral artery disease (PAD). The study seeks to find out if the Thor system is safe and effective for treating these leg artery lesions. Patients experiencing leg pain due to poor blood flow and meeting specific artery blockage criteria may be eligible to participate. All participants will receive treatment using the Thor laser atherectomy system, which involves removing calcified lesions and modifying calcium deposits in their leg arteries. During the procedure, doctors will take x-ray images of the arteries and may also use additional treatments like angioplasty balloons, drug-coated balloons, stents, or clot-collecting filters if necessary. Patients will be monitored until discharge or up to 24 hours after treatment. Participants will have follow-up visits at discharge, 30 days, 6 months, and 12 months after the procedure. Each of these visits includes medical history updates, medication reviews, physical exams of the legs, blood flow tests using arm and leg blood pressure measurements, ultrasounds of the treated leg, and assessments of walking difficulty and quality of life. The main outcomes measured include freedom from major adverse events within 30 days, procedural success, and changes in blood flow and walking ability over time. The study will last about 12 months for each participant, with enrollment over approximately 24 months.
CONDITIONS
Brief Title
The THOR IDE Study
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patient age is 18 years or older
- Patient agrees to participate and comply by signing an IRB approved consent form
- Patient can walk unassisted or with non-motorized assistive devices
- Patient has peripheral artery disease with Rutherford Class 2-4 in the target limb
- Patient has a life expectancy greater than 12 months as assessed by the investigator
- Patient has new atherosclerotic disease in the native superficial femoral or popliteal arteries
- Target lesion has 70% or more diameter narrowing
- Target lesion length is 150 mm or less
- Chronic total occlusion lesion length is less than 100 mm
- Minimum reference vessel diameter is 4.0 mm
- Target lesion crossed and guidewire placed properly without flow-limiting issues
- At least one open tibial vessel with less than 50% narrowing to the foot
- Target lesion shows moderate to severe calcification by PARC criteria
You will not qualify if you...
- Active infection requiring antibiotics
- Stenting planned in the target lesion
- Positive COVID-19 test within 2 weeks and symptoms present
- Pregnant or currently breastfeeding
- Acute limb ischemia in target limb within 7 days before procedure
- Stroke within 60 days before procedure
- Heart attack within 60 days before procedure
- Unstable coronary artery disease or other uncontrolled illness causing hospitalization within 60 days
- Allergy or contraindication to aspirin or required blood-thinning medications
- Allergy to contrast media that cannot be managed before procedure
- History of thrombophilia, heparin-induced thrombocytopenia or related conditions
- Serum creatinine over 2.5 mg/dL unless on dialysis
- Planned major lower limb amputation above the ankle
- Recent or planned surgical or endovascular procedures in target limb within specified periods
- Current participation in other interfering clinical trials
- Use of specialty balloons, re-entry, or additional atherectomy devices required for treatment
- Significant narrowing or blockage before the target treatment zone not successfully treated
- Treatment needed on the same limb below the target site during the procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Procedure day plus up to 24 hours post-procedure
Participants receive treatment with the Thor laser atherectomy system to treat calcified lesions in leg arteries. During the procedure, doctors take x-ray images and may use additional treatments such as angioplasty balloons, drug-coated balloons, stents, and filters if needed. Participants are observed for up to 24 hours after the procedure before going home.
1 procedure visit and observation period up to 24 hours
Follow-up
Duration - 12 months
Participants return for follow-up visits at 30 days, 6 months, and 12 months after the procedure. During these visits, participants undergo physical exams, blood flow tests, ultrasounds of the treated leg, and assessments of walking ability and quality of life. They are also monitored for any adverse events.
3 visits (at 30 days, 6 months, and 12 months post-procedure)
Trial Site Locations
Total: 29 locations
1
St. Helena Hospital
St. Helena, California, United States, 94574
Actively Recruiting
2
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, United States, 80045
Actively Recruiting
3
Manatee Memorial Hospital
Bradenton, Florida, United States, 34205
Actively Recruiting
4
Tallahassee Research Institute
Tallahassee, Florida, United States, 32308
Actively Recruiting
5
Guardian Research Organization
Winter Park, Florida, United States, 32792
Actively Recruiting
6
Vascular Institute of the Midwest
Davenport, Iowa, United States, 52807
Actively Recruiting
7
Cardiovascular Institute of the South
Houma, Louisiana, United States, 70360
Actively Recruiting
8
Cardiovascular Institute of the South
Lafayette, Louisiana, United States, 70503
Actively Recruiting
9
The Vascular Care Group
Portland, Maine, United States, 04106
Actively Recruiting
10
Southcoast Hospitals/Charlton Memorial Hospital
Fall River, Massachusetts, United States, 02720
Actively Recruiting
11
Vascular Breakthroughs
Leominster, Massachusetts, United States, 04153
Actively Recruiting
12
Henry Ford St John Hospital
Detroit, Michigan, United States, 22201
Actively Recruiting
13
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
14
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States, 08015
Actively Recruiting
15
Heart and Vascular Institute of Central Jersey
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
16
Atlantic Medical Imaging of New jersey
Vineland, New Jersey, United States, 08360
Actively Recruiting
17
Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
18
New York Presbyterian Hospital/Columbia University Irving Medical Center
New York, New York, United States, 10029
Actively Recruiting
19
Vascular Solutions of North Carolina
Cary, North Carolina, United States, 27518
Actively Recruiting
20
Premier Cardiovascular Institute
Fairborn, Ohio, United States, 45324
Actively Recruiting
21
Ascension St. John
Bartlesville, Oklahoma, United States, 74006
Actively Recruiting
22
UPMC
Mechanicsburg, Pennsylvania, United States, 17050
Actively Recruiting
23
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
24
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, United States, 19096
Actively Recruiting
25
The Miriam Hospital
Providence, Rhode Island, United States, 02905
Actively Recruiting
26
Vascular Institute of Chattanooga
Chattanooga, Tennessee, United States, 37421
Actively Recruiting
27
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
28
Baylor, Scott & White, The Heart Hospital
Plano, Texas, United States, 75093
Actively Recruiting
29
Sentara Health Research Center
Norfolk, Virginia, United States, 23507
Actively Recruiting
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Research Team
D
Danielle Op den Kamp
C
Clarice Scofield
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
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.
Alan T Hirsch, Ziv J Haskal, Norman R Hertzer...
https://pubmed.ncbi.nlm.nih.gov/16549646Peripheral arterial disease detection, awareness, and treatment in primary care.
A T Hirsch, M H Criqui, D Treat-Jacobson...
https://pubmed.ncbi.nlm.nih.gov/11560536Mortality rates at 10 years are higher in diabetic than in non-diabetic patients with chronic lower extremity peripheral arterial disease.
Thomas Mueller, Franz Hinterreiter, Werner Poelz...
https://pubmed.ncbi.nlm.nih.gov/27067137The morbidity and mortality following a diagnosis of peripheral arterial disease: long-term follow-up of a large database.
Jaime Caro, Kristen Migliaccio-Walle, Khajak J Ishak...
https://pubmed.ncbi.nlm.nih.gov/15972099The significance of lower extremity peripheral arterial disease.
Robert S Dieter, William W Chu, John P Pacanowski...
https://pubmed.ncbi.nlm.nih.gov/11808837Recent Trends in Endovascular and Surgical Treatment of Peripheral Arterial Disease in the Medicare Population.
David Guez, David R Hansberry, Carin F Gonsalves...
https://pubmed.ncbi.nlm.nih.gov/32097027Performance goals and endpoint assessments for clinical trials of femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease.
Krishna J Rocha-Singh, Michael R Jaff, Tami R Crabtree...
https://pubmed.ncbi.nlm.nih.gov/17377972Endovascular brachytherapy for prophylaxis of restenosis after femoropopliteal angioplasty : results of a prospective randomized study.
E Minar, B Pokrajac, T Maca...
https://pubmed.ncbi.nlm.nih.gov/11094034Angioplasty or bypass for superficial femoral artery disease? A randomised controlled trial.
E S van der Zaag, D A Legemate, M H Prins...
https://pubmed.ncbi.nlm.nih.gov/15234692