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The THOR IDE Study
NCT05916950 · View on ClinicalTrials.gov ↗
Study 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). 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 Studied
Interventions
- DEVICE Thor laser atherectomy
Study Locations (20)
Florida
- Manatee Memorial Hospital — Bradenton
- Tallahassee Research Institute — Tallahassee
- Guardian Research Organization — Winter Park
New Jersey
- Deborah Heart and Lung Center — Browns Mills
- Heart and Vascular Institute of Central Jersey — New Brunswick
- Atlantic Medical Imaging of New jersey — Vineland
Louisiana
- Cardiovascular Institute of the South — Houma
- Cardiovascular Institute of the South — Lafayette
Massachusetts
- Southcoast Hospitals/Charlton Memorial Hospital — Fall River
- Vascular Breakthroughs — Leominster
Michigan
- Henry Ford St John Hospital — Detroit
- Henry Ford Hospital — Detroit
New York
- Mount Sinai Hospital — New York
- New York Presbyterian Hospital/Columbia University Irving Medical Center — New York
California
- St. Helena Hospital — St. Helena
Colorado
- Rocky Mountain Regional VA Medical Center — Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 155 participants |
| Start Date | 2024-10-29 |
| Est. Completion | 2027-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05916950
The ClinicalTrials.gov registry entry for NCT05916950 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 155 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Philips Clinical & Medical Affairs Global, which has 186 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Peripheral Artery Disease appearing as the primary indexed condition, and to 1 intervention — of which Thor laser atherectomy is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05916950 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, New Jersey, Louisiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05916950 about?
NCT05916950 is a clinical study titled "The THOR IDE Study". 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 t...
What is the current status of trial NCT05916950?
This trial is currently recruiting. It is a NA study. The enrollment target is 155 participants. The study started on 2024-10-29. Estimated completion is 2027-12.
What conditions does trial NCT05916950 study?
This clinical trial studies the following conditions: Peripheral Artery Disease, PAD, Peripheral Artery Stenosis, Peripheral Artery Calcification. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05916950?
The interventions under investigation include: Thor laser atherectomy (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05916950?
This trial is sponsored by Philips Clinical & Medical Affairs Global, which has 186 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05916950 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Iowa, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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