Actively Recruiting
The THOR IDE Study
Led by Philips Clinical & Medical Affairs Global · Updated on 2026-03-20
155
Participants Needed
29
Research Sites
161 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
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
Official Title
The THOR IDE Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient age is 18 years or older
- Patient agrees to participate and comply with the study by signing informed consent
- Patient can walk unassisted or with non-motorized assistive devices
- Patient has peripheral artery disease with documented Rutherford Class 2-4 in the target leg
- Patient is expected to live more than 12 months according to the investigator
- Patient has new atherosclerotic disease in the native superficial femoral artery and/or popliteal arteries
- Target lesion has 70% or more diameter narrowing as visually assessed
- Target lesion length is 150 mm or less, possibly including multiple lesions
- Chronic total occlusion lesion length is less than 100 mm within the total treatment length
- Reference vessel diameter is at least 4.0 mm by visual estimate
- Target lesion was crossed and guidewire placed beyond the lesion without flow-limiting damage
- At least one tibial vessel with less than 50% narrowing provides blood flow to the foot
- Target lesion shows moderate to severe calcification based on PARC criteria
You will not qualify if you...
- Active infection requiring antibiotics
- Planned stenting within the target lesion
- Positive COVID-19 test within last 2 weeks with symptoms
- Pregnant or currently breastfeeding
- Acute limb ischemia in target leg within 7 days before procedure
- Stroke within 60 days before procedure
- Heart attack within 60 days before procedure
- Unstable coronary artery disease or other serious conditions causing hospitalization within 60 days before screening
- Allergy or contraindication to aspirin or blood-thinning medications required for the procedure
- Allergy to contrast dye that cannot be pre-treated
- History of thrombophilia, heparin-induced thrombocytopenia or related syndrome
- Serum creatinine above 2.5 mg/dL unless on dialysis
- Planned major amputation above the ankle on the target leg
- Other surgical or endovascular procedures on the target leg within 14 days before or planned within 30 days after procedure (except diagnostic angiography)
- Participation in another investigational device or drug trial that may interfere
- Use of specialty balloons, re-entry, or additional atherectomy devices needed for the target lesion
- Significant narrowing greater than 50% or blockage of inflow arteries before target lesion not successfully treated
- Need for treatment of another peripheral lesion on the same leg below the target site during the procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Research Team
D
Danielle Op den Kamp
CONTACT
C
Clarice Scofield
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here