New stent graft aims to restore blood flow in legs without major surgery

NCT ID NCT04130737

Disease control Sponsor: Endologix Source: ClinicalTrials.gov ↗

First seen Jul 10, 2026 · Last updated Jul 10, 2026

Summary

This trial evaluates a device called the TORUS Stent Graft, a mesh tube placed inside the leg artery to keep it open in people with peripheral artery disease (PAD). The study includes about 188 adults with blockages in the thigh or behind-the-knee arteries. The goal is to see if the stent graft safely improves blood flow and reduces the need for further procedures or amputation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: TORUS Stent Graft System
What this could lead to: If successful, this device could offer a less invasive way to reopen blocked leg arteries, potentially reducing the need for repeat procedures or major surgery.
What could go wrong: This is a device study with risks including bleeding, infection, or the stent graft failing to stay open. Long-term benefits are not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

188 people

The number who actually took part.

Started

Aug 2018

Finished

Feb 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patient is male or female, with age \> 18 and ≤ 90 years at date of enrollment. 2. Patient provides written informed consent before any study-specific investigations or procedures. 3. Patient is willing to undergo all follow-up assessments according to the specified schedule over 36 months. 4. Patient is a suitable candidate for angiography and endovascular intervention and, if required, is eligible for standard surgical repair. 5. Patient has symptomatic peripheral arterial disease (PAD) of the lower extremities requiring intervention to relieve de novo obstruction or occlusion or restenosis of the native femoropopliteal artery. 6. Patient has PAD classified as Rutherford classification 2, 3 or 4. 7. Patient has documented PAD by either (i) a resting ankle-brachial index (ABI) of ≤ 0.90 (or ≤ 0.75 after exercise of the target limb). Resting toe brachial index (TBI) is performed only if unable to reliably assess ABI. TBI must be \<0.70; or (ii) Normal ABI with angiographic, ultrasound, MRA, or CT evidence of ≥ 60% diameter stenosis. 8. 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. 9. Single target lesion must be covered by a single stent. Tandem target lesions are considered a single continuous lesion if the gap between lesions is ≤ 5 cm and \> 30% diameter stenosis between the lesion(s). 10. Target lesion(s) eligible for treatment under the protocol are at least least 3 cm above the bottom of the femur. 11. Target lesion(s) reference vessel diameter is between 5.0 mm and 6.7 mm by operator's visual estimate. 12. Target lesion measures ≥ 80 mm to ≤ 180 mm in overall length, with ≥ 60% diameter stenosis by operator's visual estimate. Tandem target lesions are considered a single continuous lesion if the gap between lesions is ≤ 5 cm and \> 30% diameter stenosis between the lesion(s). 13. Patient has a patent popliteal artery (no stenosis ≥ 50%) distal to the treated segment. 14. Patient has at least one patent infrapopliteal vessel (\< 50% stenosis) with run-off to the ankle. Exclusion Criteria: 1. Patient is unable or is unwilling to comply with the procedural requirements of the study protocol or will have difficulty in complying with the requirements for attending follow-up visits. 2. Patient has a comorbidity that in the investigator's opinion would limit life expectancy to less than 24 months. 3. Patient has any planned major surgical procedure (including any amputation of the target limb) within 30 days after the index procedure for this study. 4. Patient has a target vessel that has been treated with any type of surgical procedure prior to enrollment. 5. Patient has a target vessel that has been treated with bypass surgery. 6. Patient has PAD classified as Rutherford classification 0, 1, 5 or 6. 7. Patient has known or suspected active systemic infection at the time of enrollment. 8. Patient has a known coagulopathy or has bleeding diatheses, thrombocytopenia with platelet count less than 100,000/microliter or INR (international normalized ratio) \>1.8. 9. Patient has a stroke diagnosis within three months prior to enrollment. 10. Patient has a history of unstable angina or myocardial infarction within 60 days prior to enrollment. 11. Patient has a contraindication to antiplatelet, anticoagulant or thrombolytic therapies. 12. Patient has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-medicated. 13. Patient has known allergy to titanium, nickel or tantalum (does not include mild contact dermatitis due to nickel allergy). 14. Patient has received thrombolysis within 72 hours prior to the index procedure. 15. Patient has acute or chronic renal disease (e.g., as measured by a serum creatinine of \> 2.5 mg/dL or \> 220 μmol/L or GFR \< 30 ml/min), or on peritoneal or hemodialysis. 16. Patient requiring coronary intervention within seven days prior to enrollment. 17. Patient is pregnant or breast-feeding. 18. Patient is participating in another research study involving an investigational product (pharmaceutical, biologic or medical device). 19. Patient has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment. 20. Patient has significant disease or obstruction (≥ 50%) of the inflow tract that has not been successfully treated at the time of the index procedure (success measured as ≤ 30% residual stenosis, without complication). 21. Patient has no patent (≥ 50% stenosis) outflow vessel providing run-off to the ankle. 22. There is a lack of full expansion in the predilatation balloon. 23. Evidence of aneurysm or acute thrombus in target vessel.

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Conditions

The condition(s) this trial relates to.

peripheral arterial disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Peripheral arterial disease

Contacts and locations

Locations

AMITA Health

Elk Grove, Illinois, 60007, United States
Arkansas Heart

Little Rock, Arkansas, 72211, United States
Bay Area Vein & Vascular Institute

Burlingame, California, 94010, United States
Bellin Hospital

Green Bay, Wisconsin, 54301, United States
Coastal Vascular & Interventional

Pensacola, Florida, 32504, United States
Columbia University Medical Center

New York, New York, 10032, United States
Eastlake Cardiovascular

Roseville, Michigan, 48066, United States
First Coast Cardiovascular Institute

Jacksonville, Florida, 32256, United States
Florida Cardiology

Winter Park, Florida, 32792, United States
McLaren Bay Region

Bay City, Michigan, 48708, United States
MedStar Health Research Insitute

Hyattsville, Maryland, 20782, United States
Michigan Vascular Center

Flint, Michigan, 48507, United States
NC Heart & Vascular Research

Raleigh, North Carolina, 27607, United States
Naadi

Oklahoma City, Oklahoma, 73116, United States
North Central Heart

Sioux Falls, South Dakota, 57108, United States
North Dallas Research Associates

McKinney, Texas, 75069, United States
Northern Mississippi Medical Center

Tupelo, Mississippi, 38801, United States
Novant Health

Charlotte, North Carolina, 28204, United States
Palm Vascular Centers

Miami Beach, Florida, 33140, United States
Phoenix Cardiovascular Research Group

Phoenix, Arizona, 85018, United States
Prisma Health

Greenville, South Carolina, 29615, United States
Rocky Mountain Regional VAMC

Aurora, Colorado, 80045, United States
Sentara Vascular Specialists

Norfolk, Virginia, 23507, United States
Southwest CVA

Mesa, Arizona, 85206, United States
Stern Cardiovascular Foundation

Germantown, Tennessee, 38138, United States
Texas Tech

Lubbock, Texas, 79430, United States
The Lindner Center for Research & Education

Cincinnati, Ohio, 45219, United States
The Miriam Hospital

Providence, Rhode Island, 02906, United States
The Vascular Experts

Darien, Connecticut, 06820, United States
UCSF

San Francisco, California, 94143, United States
Vascular Heart & Lung Associates

Mesa, Arizona, 85206, United States
Yuma Cardiology Associates

Yuma, Arizona, 85349, United States

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