Thor Laser Atherectomy for Peripheral Artery Disease (THOR Trial)
Recruiting in Palo Alto (17 mi)
+6 other locations
Overseen ByFadi Saab, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Philips Clinical & Medical Affairs Global
No Placebo Group
Trial Summary
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 lesions
Participants will:
* Receive treatment with the Thor system
* Have follow-up visits at Discharge, 30 days, 6 months, and 12 months
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.
12345Is 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.
12678How 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.
19101112Eligibility 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
I can walk on my own or with help from devices like canes.
I have new blockages in the arteries of my upper leg.
My target lesion is severely narrowed, over 70% as assessed visually.
My cancer lesion is 150mm or shorter.
My blocked artery is less than 100mm in a segment that's under 150mm.
My procedure to place a guidewire past a blockage in my blood vessel was successful without causing major issues.
I have at least one open artery in my lower leg with good blood flow to the foot.
My leg pain occurs with walking but I can manage without assistance.
My target lesion is heavily calcified according to PARC criteria.
I am 18 years old or older.
Exclusion Criteria
I am scheduled for a major leg amputation above the ankle.
I am currently on antibiotics for an infection.
I am scheduled for a stent placement in my affected blood vessel.
My kidney function test shows creatinine levels of 2.5mg/dL or higher.
I have not had a stroke in the last 60 days.
I cannot take aspirin or blood thinners due to health reasons.
I have had signs of poor blood flow to my limbs within the last week.
I have a severe narrowing or blockage in my artery that hasn't been treated successfully.
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Thor TreatmentExperimental Treatment1 Intervention
Treatment with the Thor system
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Cardiovascular Institute of the SouthHouma, LA
Cardiovascular Institute of the SouthLafayette, LA
Vascular BreakthroughsLeominster, MA
Lankenau Institute for Medical ResearchWynnewood, PA
More Trial Locations
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Who is running the clinical trial?
Philips Clinical & Medical Affairs GlobalLead Sponsor
VasCore Vascular Ultrasound Core LabCollaborator
Massachusetts General HospitalCollaborator
NAMSACollaborator
References
Laser Atherectomy for the Treatment of Peripheral Arterial Disease. [2022]The aim of the study was to investigate the clinical results of laser atherectomy in the treatment of peripheral arterial disease.
Atherectomy-Associated Complications in the Southern California Vascular Outcomes Improvement Collaborative. [2019]Atherectomy has become an increasingly utilized modality for the endovascular treatment of peripheral arterial occlusive disease. The objective of this study was to determine the incidence and risk factors for atherectomy-associated complications.
Adverse Events After Atherectomy: Analyzing Long-Term Outcomes of Endovascular Lower Extremity Revascularization Techniques. [2022]Background The long-term effectiveness of atherectomy treatment for peripheral arterial disease is unknown. We studied 5-year clinical outcomes by endovascular treatment type among patients with peripheral arterial disease. Methods and Results We queried the Medicare-linked VQI (Vascular Quality Initiative) registry for endovascular interventions from 2010 to 2015. The exposure was treatment type: atherectomy (with or without percutaneous transluminal angioplasty [ PTA] ), stent (with or without PTA ), or PTA alone. The outcomes were major amputation, any amputation, and major adverse limb event (major amputation or any reintervention). We used the center-specific proportions of atherectomy procedures performed in the 12 months before a patient's procedure as the instruments to perform an instrumental-variable Cox model analysis. Among 16 838 eligible patients (median follow-up: 1.3-1.5 years), 11% underwent atherectomy, 40% received PTA alone, and 49% underwent stenting. Patients receiving atherectomy commonly underwent femoropopliteal artery treatment (atherectomy: 65%; PTA : 49%; stenting: 43%; P
Effects of Peripheral Arterial Disease Interventions on Survival: A Propensity-Score Matched Analysis Using VQI Data. [2022]Atherectomy is currently being used extensively for occlusive peripheral artery disease (PAD) interventions without proven benefits. This analysis examines the effects of atherectomy and other endovascular interventions on patient survival.
Peripheral atherectomy: a critical review. [2014]Atherectomy is experiencing increased interest from endovascular specialists as a therapeutic treatment in the peripheral arteries. Long studied in the coronary vasculature, atherectomy has several theoretical advantages that make it uniquely suited for the peripheral circulation. In particular, infra-inguinal peripheral arterial disease experiences physiologic stresses and forces that have made traditional percutaneous coronary treatments such as angioplasty and stenting not as successful. Restenosis has been a major problem for angioplasty and stenting alone. The SilverHawk atherectomy device has favorable short-term data but important longer-term data are limited and need further study. Laser atherectomy also has favorable applications in niche patients but the number of studies is limited. Unfortunately, athero-ablative technologies for peripheral arterial disease require more definitive objective data regarding 12-month and longer-term outcomes in order to obtain widespread scientific acceptance.
Acute Real-World Outcomes From the Phoenix Post-Approval Registry. [2022]An evaluation of the 30-day safety and performance outcomes of the Phoenix atherectomy system (Philips Volcano Corporation) was performed in real-world patients with peripheral artery disease (PAD).
Adverse events after treatment of patients with acute limb ischemia. [2015]To assess the outcome and the occurrence and consequences of adverse events (AEs) after treatment of acute limb ischemia (ALI).
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]The purpose of this study was to evaluate the safety and efficacy of excimer laser atherectomy (ELA) with adjunctive percutaneous transluminal angioplasty (PTA) versus PTA alone for treating patients with chronic peripheral artery disease with femoropopliteal bare nitinol in-stent restenosis (ISR).
Mid-term results with laser atherectomy in the treatment of infrainguinal occlusive disease. [2022]Laser atherectomy offers a potential intervention for multivessel infrainguinal disease in patients with poor revascularization options. Despite promising early results reported in the literature, the proper patient population who might benefit from laser atherectomy has yet to be determined.
Laser atherectomy for lower extremity revascularization: An adjunctive endovascular treatment option. [2006]Excimer laser atherectomy (LA) employs precision laser energy control (shallow tissue penetration) and safer wavelengths (ultraviolet as opposed to the infrared spectra in older laser technology), which decreases perforation and thermal injury to the treated vessels. Though extensively used by cardiologists for severe obstructive coronary artery disease, peripheral interventionalists have not accepted LA as a routine adjunctive technique for stenotic or occluded vessels. We report herein the technical and clinical outcomes with LA for complex peripheral vascular disease in patients deemed high-risk for conventional surgical revascularization. Over a 6-month period, 19 lesions in 15 high-risk patients (mean age 72 +/-10 years) were treated with LA (308-nm spectral wavelength) followed by balloon angioplasty for limb-threatening ischemia (n = 10) and severe disabling claudication (n = 5). The lesions were located at the superficial femoral artery (n = 8), popliteal artery (6), and/or tibial vessels (5). The mean occlusion length was 10.3 +/-2.3 cm. Laser catheter choice ranged from 1.4 to 2.5 mm depending on the target vessel diameter. Clinical examination, duplex ultrasound, and ankle-brachial indices were performed in follow-up visits. Immediate technical success was achieved in 16 (84%) lesions. In the 3 technical failures, inability to cross the lesion with a wire (n = 2) or vessel perforation (n = 1) precluded successful LA. Overall, primary patency as assessed by duplex was 57% (superficial femoral artery 71%, popliteal 60%, tibial vessels 25%). Clinical improvement was seen in 10 lesions (77%) that were successfully treated initially. One patient required below-knee amputation. At an average of 2-year follow-up, 6 patients who were initially successfully treated were alive (46%), including 3 patients (50%) with stable symptoms without the need for major amputation. Laser atherectomy is a useful adjunctive revascularization technique for high-risk patients with limb-threatening ischemia. This technique is especially beneficial in the treatment of ostial lesions, which may be prone to distal embolization, as well as total occlusions that can be traversed by a guide wire but not a balloon. Vascular surgeons should add LA to their endovascular armamentarium for the treatment of complex peripheral vascular disease in the high surgical risk patients. Further study of clinical outcome measures and comparison to other interventional techniques are warranted.
The role of atherectomy in BTK lesions: a systematic review. [2022]The aim of this paper was to evaluate the current role of atherectomy techniques (ATH) in treatment of peripheral arterial disease (PAD) at below the knee (BTK) arteries.
Two-year follow-up after laser thermal balloon angioplasty (LTBA) in lower extremities: initial experience. [2019]We describe the results obtained with the use of laser thermal balloon angioplasty (LTBA) in the treatment of atherosclerosis obliterans of the lower limbs in 37 patients (34 males, 3 females, mean age 58 +/- 9 years) with occlusive arterial disease (Fontaine stages II-IV) presenting 39 significant lesions. Immediate results and two years of clinical follow-up are analyzed. Initial ankle/brachial Doppler index was 0.51 +/- 0.17. Eighteen lesions were located in the iliac area (13 stenoses 2.3 +/- 1 cm and 5 occlusions 4.2 +/- 3 cm) and 21 lesions in the femoropopliteal area (5 stenoses 2.6 +/- 2 cm and 16 occlusions 5.7 +/- 3 cm). A percutaneous procedure was used in 38 cases. In only one case was femoral dissection needed. The laser source was argon in 26 cases and Nd-YAG in 13. Initial success was 85% (89% in iliac lesions and 81% in femoropopliteal lesions; 100% in stenoses and 70% in occlusions). The presence of occlusion (p less than 0.01) and/or calcium (p less than 0.05) negatively influenced the immediate results. No major complications were observed; seven (17%) minor complications occurred. Ankle/brachial Doppler index after treatment was 0.82 +/- 0.21. Cumulative clinical patency for successfully treated patients after two-year follow-up was 91%. LTBA thus represents an effective and less aggressive way of treating peripheral atherosclerosis obliterans. In spite of some limitations, it is useful in selected patients. The results of this study are very much like those in the literature for similar series and early experience.