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TORUS Stent Graft System for Peripheral Arterial Disease
Study Summary
This trial is testing a new stent graft system to see if it is safe and effective in treating atherosclerotic lesions in the native SFA or superficial femoral and/or proximal popliteal arteries.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am not planning any major surgery within 30 days after joining this study.I needed a heart procedure within the last week.I cannot take blood thinning or clot-dissolving medications due to health reasons.I have received a clot-dissolving treatment within the last 3 days.I have had surgery on a blood vessel that will be the focus of this study.I am eligible for procedures to view and treat blood vessel issues, including surgery if needed.I have blockages in the artery of my upper leg that can be treated with a wire.I have a health condition that may shorten my life to under 2 years.I have kidney disease or am on dialysis.You have a bulging blood vessel or a recent blood clot in the area being studied.My leg pain is moderate to severe when walking.My artery in the knee area is not significantly narrowed.I have a major blockage in my heart that hasn't been effectively treated.My single target lesion can be treated with one stent.My target lesion is between 80 and 180 mm long with significant narrowing.I need treatment for blocked arteries in my legs causing symptoms.My target lesion is located more than 3 cm above the bottom of my thigh bone.My blood vessels in the leg are not severely narrowed.I have had a heart attack or severe chest pain in the last 60 days.I have had bypass surgery on a blood vessel.I was diagnosed with a stroke in the last three months.My PAD is classified as mild or very severe.The balloon used to expand a narrowed blood vessel did not fully open.I do not have an active infection.I am between 18 and 90 years old.I have been diagnosed with PAD through specific tests showing reduced blood flow.You have a known allergy to titanium, nickel, or tantalum, unless it's just a mild rash from nickel.The size of the target blood vessels is between 5.0 mm and 6.7 mm, as estimated by the doctor.I have at least one open blood vessel below my knee with good blood flow to my ankle.I have a bleeding disorder or my blood doesn't clot properly.
- Group 1: TORUS Stent Graft System
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there various places in the US administering this clinical research?
"HonorHealth located in Scottsdale, Arizona; Advanced Cardiovascular Specialists found in Mountain View, California; and Massachusetts General Hospital based in Boston are all participating sites of this clinical trial. Additionally, there are 37 other centres taking part across the United States."
Can octogenarians participate in this research program?
"This clinical trial is available to individuals aged 18-90, but those under the age of 18 have 11 trials and seniors over 65 can choose from 209."
Are there any new opportunities to participate in this scientific experiment?
"Based on the information posted online, this clinical trial is no longer seeking candidates. The study was first launched in October 2019 and last edited in July 2022. Despite that, there are 216 other trials currently recruiting patients right now."
What criteria are necessary to meet the requirements of participation in this trial?
"This clinical trial seeks 188 enrollees aged 18 to 90 that possess peripheral arterial disease. To be approved, patients must consent in writing prior to any studies being conducted and meet the following criteria: have a single target lesion covered by a stent; demonstrate symptoms of PAD via ABI ≤ 0.90 (or ≤ 0.75 after exercise) or TBI <0.70; present angiographic evidence of 60% diameter stenosis; show lesions ≥3 cm above the femur bottom eligible for treatment under protocol, among other conditions."
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