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Atherectomy Device

Thor Laser Atherectomy for Peripheral Artery Disease (THOR Trial)

N/A
Recruiting
Led By Fadi Saab, MD
Research Sponsored by Philips Clinical & Medical Affairs Global
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient is able to walk unassisted or with non-motorized assistive devices
Patient has de novo atherosclerotic disease of the native SFA and/or the femoropopliteal arteries
Must not have
Planned lower limb major amputation (above the ankle)
Subject has active infection requiring antibiotic therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test a system called Thor in adult patients with new calcified lesions in the leg arteries. It wants to find out if the Thor system is safe and effective in treating these lesions.

Who is the study for?
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.
What is being tested?
The THOR IDE Study is evaluating the safety and effectiveness of the Thor laser atherectomy system in treating newly diagnosed calcified lesions in patients' leg arteries. Participants will be treated with this system and monitored for up to one year.
What are the potential side effects?
While specific side effects are not listed here, typical risks may include discomfort at the treatment site, bleeding, potential damage to surrounding tissues or vessels during the procedure, infection risk post-treatment, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can walk on my own or with help from devices like canes.
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I have new blockages in the arteries of my upper leg.
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My target lesion is severely narrowed, over 70% as assessed visually.
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My cancer lesion is 150mm or shorter.
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My blocked artery is less than 100mm in a segment that's under 150mm.
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My procedure to place a guidewire past a blockage in my blood vessel was successful without causing major issues.
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I have at least one open artery in my lower leg with good blood flow to the foot.
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My leg pain occurs with walking but I can manage without assistance.
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My target lesion is heavily calcified according to PARC criteria.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am scheduled for a major leg amputation above the ankle.
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I am currently on antibiotics for an infection.
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I am scheduled for a stent placement in my affected blood vessel.
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My kidney function test shows creatinine levels of 2.5mg/dL or higher.
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I have not had a stroke in the last 60 days.
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I cannot take aspirin or blood thinners due to health reasons.
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I have had signs of poor blood flow to my limbs within the last week.
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I have a severe narrowing or blockage in my artery that hasn't been treated successfully.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Procedural Success
Secondary study objectives
Adjunctive devices used with the Thor system
Ankle-Brachial Index (ABI) change, 12 months
Ankle-Brachial Index (ABI) change, 30 days
+18 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Thor TreatmentExperimental Treatment1 Intervention
Treatment with the Thor system

Find a Location

Who is running the clinical trial?

VasCore Vascular Ultrasound Core LabUNKNOWN
1 Previous Clinical Trials
30 Total Patients Enrolled
1 Trials studying Peripheral Arterial Disease
30 Patients Enrolled for Peripheral Arterial Disease
Philips Clinical & Medical Affairs GlobalLead Sponsor
58 Previous Clinical Trials
17,184 Total Patients Enrolled
6 Trials studying Peripheral Arterial Disease
831 Patients Enrolled for Peripheral Arterial Disease
NAMSAOTHER
52 Previous Clinical Trials
20,668 Total Patients Enrolled
3 Trials studying Peripheral Arterial Disease
827 Patients Enrolled for Peripheral Arterial Disease
~103 spots leftby Oct 2026
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