The THOR IDE Study (NCT05916950)
๐ฉบ Plain-English Summary (8th-Grade Level)
The goal of this clinical trial is to test the Thor system in adult (โฅ 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
Who can join: Review the eligibility criteria below.
Location: St. Helena Hospital โ St. Helena, California
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (29 Sites)
Showing the first 25 of 29 sites.
- St. Helena Hospital โ St. Helena, California
- Rocky Mountain Regional VA Medical Center โ Aurora, Colorado
- Manatee Memorial Hospital โ Bradenton, Florida
- Tallahassee Research Institute โ Tallahassee, Florida
- Guardian Research Organization โ Winter Park, Florida
- Vascular Institute of the Midwest โ Davenport, Iowa
- Cardiovascular Institute of the South โ Houma, Louisiana
- Cardiovascular Institute of the South โ Lafayette, Louisiana
- The Vascular Care Group โ Portland, Maine
- Southcoast Hospitals/Charlton Memorial Hospital โ Fall River, Massachusetts
- Vascular Breakthroughs โ Leominster, Massachusetts
- Henry Ford St John Hospital โ Detroit, Michigan
- Henry Ford Hospital โ Detroit, Michigan
- Deborah Heart and Lung Center โ Browns Mills, New Jersey
- Heart and Vascular Institute of Central Jersey โ New Brunswick, New Jersey
- Atlantic Medical Imaging of New jersey โ Vineland, New Jersey
- Mount Sinai Hospital โ New York, New York
- New York Presbyterian Hospital/Columbia University Irving Medical Center โ New York, New York
- Vascular Solutions of North Carolina โ Cary, North Carolina
- Premier Cardiovascular Institute โ Fairborn, Ohio
- Ascension St. John โ Bartlesville, Oklahoma
- UPMC โ Mechanicsburg, Pennsylvania
- Hospital of the University of Pennsylvania โ Philadelphia, Pennsylvania
- Lankenau Institute for Medical Research โ Wynnewood, Pennsylvania
- The Miriam Hospital โ Providence, Rhode Island
๐ Contact the Study Coordinator
Phone: +31 (0)6 27218737
Email: Danielle.op.den.kamp@philips.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Peripheral Artery Disease
- Monitoring Local Tissue Oxygen Changes Using the Wireless Lumee Oxygen Platform in Correlation to TcPO2 โ San Francisco, California
- Far Red Light to Improve Functioning in PAD โ Birmingham, Alabama
- Intermittent Pneumatic Compression With and Without Exercise to Improve Functioning in Peripheral Artery Disease โ Chicago, Illinois
- Telehealth to Improve Functional Status and Quality of Life in Veterans With PAD โ Durham, North Carolina
- BEETroot Juice to Reverse Functional Impairment in PAD โ Chicago, Illinois
- Exercise Therapy for PAD Using Mobile Health โ Decatur, Georgia
Explore by condition: All Peripheral Artery Disease clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.