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NCT05916950 · ClinicalTrials.gov registry record · NA
The THOR IDE Study
A NA study of Peripheral Artery Disease and PAD, sponsored by Philips Clinical & Medical Affairs Global.
- Recruiting
- Registry status
- NA
- Development phase
- 155
- Enrollment target
- 20
- Study locations
NCT05916950: Recruiting NA study of Peripheral Artery Disease and PAD, sponsored by Philips Clinical & Medical Affairs Global.
NCT05916950 is a NA study of Peripheral Artery Disease and PAD that is actively recruiting participants, run by Philips Clinical & Medical Affairs Global. The registered enrollment target is 155 participants, above the 124-participant average among 50 other Peripheral Artery Disease trials with a reported enrollment target (25% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05916950, a NA study of Peripheral Artery Disease and PAD, is actively recruiting participants, sponsored by Philips Clinical & Medical Affairs Global.
- RECRUITING
- Registry status
- NA
- Development phase
- 155 participants
- Enrollment target
- 20
- Study locations
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
Primary Outcome
Defined as freedom from MAEs including all-cause mortality, clinically driven target lesion revascularization (CD-TLR), unplanned target limb major amputation, perforations, flow-limiting dissections, and symptomatic distal embolizations that require an intervention to resolve
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 |
What NCT05916950 shows while recruiting
NCT05916950 is an interventional study that assigns participants to a tested intervention. The registered 155 participants enrollment target is mid-sized for trials with a published cap, above the 124-participant average among 50 other Peripheral Artery Disease trials with a reported enrollment target (25% higher).
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.
NCT05916950 names 20 study sites across 12 states, led by Florida, New Jersey, Louisiana.
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.
What interventions are being tested in trial NCT05916950?
The interventions under investigation include: Thor laser atherectomy (DEVICE).
Who is sponsoring clinical trial NCT05916950?
This trial is sponsored by Philips Clinical & Medical Affairs Global, which has 45 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05916950's enrollment target sits among peer trials
155 18th of 50 higher than 32 of 50 other Peripheral Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Peripheral Artery Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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