155 Participants Needed

Thor Laser Atherectomy for Peripheral Artery Disease

(THOR Trial)

Recruiting at 13 trial locations
JM
CS
Overseen ByClarice Scofield
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

Research shows that laser atherectomy, a technique used in the Thor treatment, has been used successfully in niche patients with peripheral artery disease, although more studies are needed to confirm long-term benefits.12345

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

PN

Pradeep Nair, MD

Principal Investigator

Cardiovascular Institute of the South (CIS)

EG

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

Patient agrees to participate and to comply with the protocol by signing an IRB approved patient consent form
Life expectancy >12 months
I can walk on my own or with help from devices like canes.
See 9 more

Exclusion Criteria

Known allergy to contrast media that cannot adequately be premedicated prior to study procedure
I am scheduled for a major leg amputation above the ankle.
The use of specialty balloons, re-entry or additional atherectomy devices
See 14 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive treatment with the Thor system, including potential use of adjunctive devices such as angioplasty balloons, drug-coated balloons, stents, and filters

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up visits at Discharge, 30 days, 6 months, and 12 months

12 months
4 visits (in-person)

Treatment Details

Interventions

  • Thor
Trial Overview 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Thor TreatmentExperimental Treatment1 Intervention
Treatment with the Thor system

Find a Clinic Near You

Who Is Running the Clinical Trial?

Philips Clinical & Medical Affairs Global

Lead Sponsor

Trials
61
Recruited
17,600+

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

Trials
2
Recruited
190+

Syntropic Corelab

Collaborator

Trials
2
Recruited
30+

Massachusetts General Hospital

Collaborator

Trials
3,066
Recruited
13,430,000+

NAMSA

Collaborator

Trials
55
Recruited
21,500+

Findings from Research

Laser atherectomy is a safe and effective treatment for peripheral arterial disease, achieving a technical success rate of 99% with very few complications (less than 1%) in a study of 300 patients over 7 years.
At a mean follow-up of 28 months, 45% of patients experienced significant clinical improvement, but those with diabetes, on dialysis, or with critical limb ischemia were less likely to benefit, highlighting the need for careful patient selection.
Laser Atherectomy for the Treatment of Peripheral Arterial Disease.Mallios, A., Blebea, J., Buster, B., et al.[2022]
In a study of 729 atherectomy procedures performed over five years, complications occurred in 11.1% of cases, with dissection being the most common at 7%.
The length of the treated artery was found to be a significant risk factor for complications, with longer treatment lengths associated with a higher risk, while demographic factors like age, diabetes, and smoking did not predict complications.
Atherectomy-Associated Complications in the Southern California Vascular Outcomes Improvement Collaborative.Azar, Y., DeRubertis, B., Baril, D., et al.[2019]
In a study of 16,838 patients with peripheral arterial disease, those treated with atherectomy had a higher risk of major adverse limb events (38%) compared to those treated with percutaneous transluminal angioplasty (PTA) (33%) and stenting (32%).
Atherectomy was associated with significantly higher risks of major amputation (3.66 times more likely) and any amputation (2.73 times more likely) compared to stenting, indicating that while atherectomy is used for severe cases, it may lead to worse long-term outcomes.
Adverse Events After Atherectomy: Analyzing Long-Term Outcomes of Endovascular Lower Extremity Revascularization Techniques.Ramkumar, N., Martinez-Camblor, P., Columbo, JA., et al.[2022]

References

Laser Atherectomy for the Treatment of Peripheral Arterial Disease. [2022]
Atherectomy-Associated Complications in the Southern California Vascular Outcomes Improvement Collaborative. [2019]
Adverse Events After Atherectomy: Analyzing Long-Term Outcomes of Endovascular Lower Extremity Revascularization Techniques. [2022]
Effects of Peripheral Arterial Disease Interventions on Survival: A Propensity-Score Matched Analysis Using VQI Data. [2022]
Peripheral atherectomy: a critical review. [2014]
Acute Real-World Outcomes From the Phoenix Post-Approval Registry. [2022]
Adverse events after treatment of patients with acute limb ischemia. [2015]
Randomized controlled study of excimer laser atherectomy for treatment of femoropopliteal in-stent restenosis: initial results from the EXCITE ISR trial (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis). [2022]
Mid-term results with laser atherectomy in the treatment of infrainguinal occlusive disease. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Laser atherectomy for lower extremity revascularization: An adjunctive endovascular treatment option. [2006]
The role of atherectomy in BTK lesions: a systematic review. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Two-year follow-up after laser thermal balloon angioplasty (LTBA) in lower extremities: initial experience. [2019]
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