The THOR IDE Study (NCT05916950)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Patient age is ≥18 years
2. Patient agrees to participate and to comply with the protocol by signing an IRB approved patient consent form
3. Patient is able to walk unassisted or with non-motorized assistive devices
4. Patient has PAD with documented Rutherford Class 2-4 of the target limb
5. Anticipated life expectancy \>12 months, in the opinion of the investigator at the time of enrollment. Angiographic Inclusion Criteria:
6. Patient has de novo atherosclerotic disease of the native SFA and/or the popliteal arteries
7. Target lesion has ≥70% diameter stenosis by investigator via visual assessment
8. Target lesion length ≤150mm. Total treatment zone may not exceed 150mm, and may include one or more lesions.
9. Chronic total occlusion lesion length is \<100mm of the total ≤150mm target lesion
10. Minimum reference vessel diameter (RVD) 4.0mm by visual estimate
11. 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
12. At least one patent tibial vessel (defined as \<50% stenosis) with runoff to the foot

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (29 Sites)

• St. Helena Hospital — St. Helena, California
• Rocky Mountain Regional VA Medical Center — Aurora, Colorado
• Manatee Memorial Hospital — Bradenton, Florida
• Tallahassee Research Institute — Tallahassee, Florida
• Guardian Research Organization — Winter Park, Florida
• Vascular Institute of the Midwest — Davenport, Iowa
• Cardiovascular Institute of the South — Houma, Louisiana
• Cardiovascular Institute of the South — Lafayette, Louisiana
• The Vascular Care Group — Portland, Maine
• Southcoast Hospitals/Charlton Memorial Hospital — Fall River, Massachusetts
• Vascular Breakthroughs — Leominster, Massachusetts
• Henry Ford St John Hospital — Detroit, Michigan
• Henry Ford Hospital — Detroit, Michigan
• Deborah Heart and Lung Center — Browns Mills, New Jersey
• Heart and Vascular Institute of Central Jersey — New Brunswick, New Jersey
• Atlantic Medical Imaging of New jersey — Vineland, New Jersey
• Mount Sinai Hospital — New York, New York
• New York Presbyterian Hospital/Columbia University Irving Medical Center — New York, New York
• Vascular Solutions of North Carolina — Cary, North Carolina
• Premier Cardiovascular Institute — Fairborn, Ohio
• Ascension St. John — Bartlesville, Oklahoma
• UPMC — Mechanicsburg, Pennsylvania
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania
• Lankenau Institute for Medical Research — Wynnewood, Pennsylvania
• The Miriam Hospital — Providence, Rhode Island

💰 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 § 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.