Thor Laser Atherectomy for Peripheral Artery Disease
(THOR Trial)
Trial Summary
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you have a known contraindication to aspirin or antiplatelet/anticoagulant therapies, you may not be eligible to participate.
What data supports the effectiveness of the treatment Thor Laser Atherectomy for Peripheral Artery Disease?
Is Thor Laser Atherectomy safe for humans?
Studies on laser atherectomy, including the Phoenix system and excimer laser atherectomy, show that it is generally safe for treating peripheral artery disease, though there can be complications. These studies provide safety data for similar treatments, indicating that while generally safe, there are risks involved.12678
How does the Thor Laser Atherectomy treatment differ from other treatments for Peripheral Artery Disease?
Thor Laser Atherectomy is unique because it uses precision laser energy with shallow tissue penetration and safer ultraviolet wavelengths, reducing the risk of vessel damage compared to older laser technologies. This makes it particularly beneficial for high-risk patients with complex peripheral vascular disease, especially in cases where traditional surgical options are not viable.19101112
What is the purpose of this trial?
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 lesionsParticipants will:* Receive treatment with the Thor system* Have follow-up visits at Discharge, 30 days, 6 months, and 12 months
Research Team
Pradeep Nair, MD
Principal Investigator
Cardiovascular Institute of the South (CIS)
Elizabeth Genovese
Principal Investigator
University of Pennsylvania
Eligibility Criteria
Adults over 18 with new, untreated calcified leg artery blockages (PAD) who can walk on their own or with help from non-motorized devices. They must have a life expectancy over a year and agree to follow the study's rules, including consent form signing and attending follow-up visits.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive treatment with the Thor system, including potential use of adjunctive devices such as angioplasty balloons, drug-coated balloons, stents, and filters
Follow-up
Participants are monitored for safety and effectiveness after treatment with follow-up visits at Discharge, 30 days, 6 months, and 12 months
Treatment Details
Interventions
- Thor
Find a Clinic Near You
Who Is Running the Clinical Trial?
Philips Clinical & Medical Affairs Global
Lead Sponsor
Roy Jakobs
Philips Clinical & Medical Affairs Global
Chief Executive Officer since 2022
MBA from Erasmus University Rotterdam
Carla Goulart Peron
Philips Clinical & Medical Affairs Global
Chief Medical Officer since 2023
MD from an unspecified institution
VasCore Vascular Ultrasound Core Lab
Collaborator
Syntropic Corelab
Collaborator
Massachusetts General Hospital
Collaborator
NAMSA
Collaborator