New device aims to tame dangerous aortic bulges

NCT ID NCT02009644

Disease control Sponsor: Bolton Medical Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new device called the Treovance Stent-Graft to treat abdominal aortic aneurysms (a bulge in the main artery). The device is placed inside the artery to reinforce the weak spot and prevent rupture. About 158 adults aged 18-85 with aneurysms large enough to need treatment are taking part. The goal is to see if the device is safe and works well at keeping the aneurysm from growing or causing complications.

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

158 people

The number who actually took part.

Started

Nov 2013

Expected to finish

Jun 2026

An estimate. End dates often move.

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 85 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. Subject must be between the ages of 18 and 85 2. Subject must be diagnosed with an infrarenal abdominal aortic aneurysm (AAA), with or without iliac artery involvement, by CT with contrast performed within 4 months of planned implant procedure 3. Subject must have an infrarenal AAA that i. is \> 4.5 cm in diameter for males, or \> 4.0 cm in diameter for females, or ii. has increased in diameter by 0.5 cm in the last 6 months 4. Subject must have i. infrarenal landing neck length of 10 mm or greater and an angle of less than 60 degrees relative to the long axis of the aneurysm (centerline at lowest renal to centerline at bifurcation) and a suprarenal neck angle of less than 45 degrees relative to the infrarenal neck axis and an outside diameter of 17 mm -32 mm, or ii. infrarenal landing neck length of 15 mm or greater and an angle of between 60 and 75 degrees relative to the long axis of the aneurysm and a suprarenal neck angle of less than 45 degrees relative to the infrarenal neck axis and an outside diameter of 16 mm-30 mm 5. Subject's infrarenal landing neck must meet the vessel size requirements specified in the instructions for use (IFU) for the corresponding devices 6. Subject must have lowest renal artery at least 9 cm from the aortic bifurcation 7. Subject must have a distal iliac landing neck with i. an inside diameter of 8 mm - 13 mm and a length of at least 10 mm, or ii. an inside diameter of \>13 mm - 20 mm and a length of at least 15 mm 8. Subject's distal iliac landing neck must meet the vessel size requirements specified for the corresponding devices in the IFU 9. Subject must have a total treatment length of at least 13 cm 10. Subject must have a distal aortic diameter above the iliac bifurcation equal to or greater than 70% of the sum of the selected leg graft diameters that will pass through the same 11. Subject must be willing and able to comply with 1-month, 6-month, and 12-month follow-up visits, as well as annual visits out to 5 years 12. Subject must have adequate renal function to tolerate required follow-up contrast-enhanced CTs 13. Subject must have adequate vascular access (e.g., patent iliac or femoral arteries) for introduction of the Navitel Delivery System, which is 18F (6 mm) or 19F (6.3 mm) outer diameter based on size of device used. Alternatively, subject's anatomy is suitable for creation of an iliac conduit. 14. Subject or Legally Authorized Representative (LAR) must agree to sign Informed Consent Form Exclusion Criteria: 1. Subject is pregnant or lactating 2. Subject has a dissection in abdominal aorta, ruptured aneurysm, or symptomatic aneurysm (as determined by treating physician) 3. Subject has a patent inferior mesenteric artery that cannot be sacrificed and an occluded or stenotic celiac and/or superior mesenteric artery 4. Implant procedure as planned does not allow for at least one patent hypogastric artery left intact, unless both are occluded on pre-op imaging 5. Subject has a lesion that cannot be crossed by a guide wire 6. Proximal neck cannot increase by more than 10% over 15mm or more than 7% over 10mm; i.e., no trapezoidal necks 7. Subject has severe untreated coronary artery disease and/or unstable angina, significant areas of myocardium at risk (based on coronary angiogram or radionuclide scans), left ventricular ejection fraction \< 20%, or recent diagnosis of Congestive Heart Failure (CHF) 8. Subject has had a stroke or myocardial infarction within 6 months of the planned treatment date 9. Subject has chronic obstructive pulmonary disease requiring routine need for oxygen therapy outside the hospital setting (e.g., daily or nightly home use) 10. Subject has an active systemic infection or is suspected of having an active systemic infection (e.g.,AIDS/HIV, sepsis) 11. Subject is morbidly obese (more than 100% over the ideal body weight or as defined by institutional standards) or has other clinical conditions that severely compromise or impair x-ray visualization of the aorta 12. Subject has connective tissue disease (e.g., Marfan's syndrome) 13. Subject has a mycotic aneurysm 14. Subject has significant or circumferential calcification or mural thrombus in the proximal aortic neck 15. Subject has significant or circumferential calcification or mural thrombus in the distal iliac landing zone 16. Subject has significant or circumferential calcification or mural thrombus within the treatment length, which may adversely impact device patency 17. Subject has a blood coagulation disorder or bleeding diathesis, the treatment for which cannot be suspended pre- and post-repair 18. Subject is in acute or chronic renal failure (creatinine \> 2.5 mg/dL) unless subject is stable on dialysis 19. Subject has less than two-year life expectancy as evidenced by factors prohibiting major medical intervention (e.g., presence of malignancy, severe cardiopulmonary disease, etc.) 20. Subject is participating in another research study, has received investigational study drug within 30 days of planned procedure, or has received an investigational device within one year of planned procedure 21. Subject is confronted with other medical, social or psychological issues that the investigator believes may interfere with study treatment or follow-up. These reasons must be documented. An example may include adherence to a theological or personal doctrine with aversion or opposition to blood transfusion. 22. Subject has had a prior AAA repair (endovascular or surgical) 23. Subject has an untreatable allergy or sensitivity to contrast media, nitinol/nickel, or polyester 24. Subject has undergone other major surgical or medical intervention within 45 days of the planned procedure or is planning to undergo other major surgical or medical intervention within 45 days post implantation (e.g., Coronary Artery Bypass Graft (CABG), organ transplantation, renal stenting, etc.)

Get updates

Get notified about this study

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

abdominal aortic aneurysm Aneurysm

As listed by the trial registrant

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

Abdominal aortic aneurysm (AAA)

Contacts and locations

Locations

Affiliated Surgeons of Rockford Memorial Hospital

Rockford, Illinois, 61103, United States
Arizona Heart Institute

Phoenix, Arizona, 85006, United States
Buffalo General Medical Center

Buffalo, New York, 14203, United States
Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States
Community Care (previously Albany Medical Center)

Albany, New York, 12205, United States
Danbury Hospital

Danbury, Connecticut, 06810, United States
East Carolina University / Pitt County Memorial Hospital

Greenville, North Carolina, 27834, United States
Lynn Heart and Vascular Institute

Boca Raton, Florida, 33486, United States
Massachusetts General Hospital

Boston, Massachusetts, 02114, United States
Mayo Clinic

Rochester, Minnesota, 55905, United States
Mission Hospital

Asheville, North Carolina, 28801, United States
Mount Sinai Medical Center

New York, New York, 10029, United States
North Central Heart (Avera Heart Hospital)

Sioux Falls, South Dakota, 51108, United States
Northside Hospital Heart & Vascular Institute

Atlanta, Georgia, 30342, United States
Presence Medical Center -- Christie Clinic

Champaign, Illinois, 61820, United States
Rhode Island Hospital

Providence, Rhode Island, 02905, United States
Sanford University of South Dakota Medical Center

Sioux Falls, South Dakota, 57117, United States
Sentara Vascular Specialists

Norfolk, Virginia, 23507, United States
Stony Brook Medical Center

Stony Brook, New York, 11794-8191, United States
Temple University School of Medicine

Philadelphia, Pennsylvania, 19140, United States
The Ohio State University

Columbus, Ohio, 43210, United States
Tufts University Medical Center

Boston, Massachusetts, 02111, United States
University of Alabama-Birmingham

Birmingham, Alabama, 35294, United States
University of Chicago

Chicago, Illinois, 60637, United States
University of Iowa Hospital and Clinic

Iowa City, Iowa, 52242, United States
University of Massachusetts

Worcester, Massachusetts, 01655, United States
University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States
University of Rochester -- Strong Memorial Hospital

Rochester, New York, 14623, United States
York Hospital

York, Pennsylvania, 17403, United States