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Stent Graft
TORUS Stent Graft System for Peripheral Arterial Disease
N/A
Waitlist Available
Research Sponsored by Endologix
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient has single or multiple stenotic, restenotic or occlusive lesions within the native femoropopliteal artery ("target lesions") that can be crossed with a guidewire and fully dilated.
Patient has PAD classified as Rutherford classification 2, 3 or 4.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from procedure to 1, 6 and 12 months
Awards & highlights
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.
Who is the study for?
The TORUS 2 trial is for adults aged 18-90 with Peripheral Arterial Disease (PAD) who have blockages in the femoropopliteal artery. They must be able to follow a 36-month follow-up plan, have not had certain recent heart problems or surgeries, and cannot be pregnant or breastfeeding. Participants need at least one open vessel below the knee and can't join if they've had some treatments before or have severe kidney issues.Check my eligibility
What is being tested?
This study tests the TORUS Stent Graft System's safety and effectiveness in treating obstructive lesions caused by PAD in arteries above the knee. Patients will receive this device through an endovascular procedure, which is less invasive than traditional surgery.See study design
What are the potential side effects?
While specific side effects are not listed here, similar procedures may include risks like bleeding at the insertion site, infection, allergic reactions to materials or medications used during treatment, blood clots within stents, and potential injury to surrounding vessels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have blockages in the artery of my upper leg that can be treated with a wire.
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My leg pain is moderate to severe when walking.
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My artery in the knee area is not significantly narrowed.
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My single target lesion can be treated with one stent.
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My target lesion is between 80 and 180 mm long with significant narrowing.
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I need treatment for blocked arteries in my legs causing symptoms.
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My target lesion is located more than 3 cm above the bottom of my thigh bone.
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I have been diagnosed with PAD through specific tests showing reduced blood flow.
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I have at least one open blood vessel below my knee with good blood flow to my ankle.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from procedure to 1, 6 and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from procedure to 1, 6 and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Freedom from a Major Adverse Event (MAE)
Primary Patency
Secondary outcome measures
Adverse Event Rate
Alternative Patency Rate
Assisted Primary Patency Rate
+14 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: TORUS Stent Graft SystemExperimental Treatment1 Intervention
The TORUS Stent Graft System (SGS) is comprised of a Stent Graft (SG) and a Stent Graft Delivery System (SGDS).
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Who is running the clinical trial?
EndologixLead Sponsor
22 Previous Clinical Trials
3,784 Total Patients Enrolled
3 Trials studying Peripheral Arterial Disease
524 Patients Enrolled for Peripheral Arterial Disease
PQ Bypass, Inc.Industry Sponsor
5 Previous Clinical Trials
432 Total Patients Enrolled
5 Trials studying Peripheral Arterial Disease
432 Patients Enrolled for Peripheral Arterial Disease
SyntactxNETWORK
22 Previous Clinical Trials
1,147,251 Total Patients Enrolled
3 Trials studying Peripheral Arterial Disease
600,142 Patients Enrolled for Peripheral Arterial Disease
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: TORUS Stent Graft System
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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