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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.
Must not have
Patient requiring coronary intervention within seven days prior to enrollment.
Patient has a contraindication to antiplatelet, anticoagulant or thrombolytic therapies.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from procedure to 1, 6 and 12 months
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I needed a heart procedure within the last week.
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I cannot take blood thinning or clot-dissolving medications due to health reasons.
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I have received a clot-dissolving treatment within the last 3 days.
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I have had surgery on a blood vessel that will be the focus of this study.
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I have kidney disease or am on dialysis.
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I have a major blockage in my heart that hasn't been effectively treated.
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My blood vessels in the leg are not severely narrowed.
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I have had bypass surgery on a blood vessel.
Select...
My PAD is classified as mild or very severe.
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I do not have an active infection.
Select...
I have a bleeding disorder or my blood doesn't clot properly.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from procedure to 1, 6 and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from procedure to 1, 6 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
Freedom from a Major Adverse Event (MAE)
Primary Patency
Secondary study objectives
Alternative Patency Rate
Assisted Primary Patency Rate
Major Adverse Event (MAE) Rate
+7 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: 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).

Find a Location

Who is running the clinical trial?

EndologixLead Sponsor
22 Previous Clinical Trials
3,822 Total Patients Enrolled
3 Trials studying Peripheral Arterial Disease
465 Patients Enrolled for Peripheral Arterial Disease
PQ Bypass, Inc.Industry Sponsor
5 Previous Clinical Trials
373 Total Patients Enrolled
5 Trials studying Peripheral Arterial Disease
373 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

Media Library

TORUS Stent Graft System (Stent Graft) Clinical Trial Eligibility Overview. Trial Name: NCT04130737 — N/A
Peripheral Arterial Disease Research Study Groups: TORUS Stent Graft System
Peripheral Arterial Disease Clinical Trial 2023: TORUS Stent Graft System Highlights & Side Effects. Trial Name: NCT04130737 — N/A
TORUS Stent Graft System (Stent Graft) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04130737 — N/A
~31 spots leftby Dec 2025
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