Clinical Study of the Treovance Stent-Graft for Patients With Abdominal Aortic Aneurysms

NCT02009644 | Active Not Recruiting DMC FDA Device

• 1 other identifier: IP-0008-12
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 29

Brief Summary

The purpose of this clinical trial is to assess and evaluate the safety and efficacy of the Treovance Stent-Graft with Navitel Delivery System in subjects with Abdominal Aortic Aneurysms (AAA).

Conditions

Abdominal Aortic Aneurysm (AAA)

Keywords

Abdominal Aortic Aneurysm; AAA; Aneurysm

Outcome Measures

Primary Outcomes (2)

• Primary Efficacy

  Successful aneurysm treatment which is a composite of the following: Technical success at the conclusion of the procedure; absence of aneurysm enlargement; absence of device-related complications (e.g., fracture, conversion to open surgical repair, etc.)

  12 months

• Primary Safety

  The primary safety endpoint is composite major adverse event (MAE) rate (including myocardial infarction, stroke, respiratory failure, etc.)

  30 days

Secondary Outcomes (7)

• Secondary Efficancy Endpoint -- Aneurysm-Related Mortality

  Annually to 5-years; annually to 10-years (stent-fracture subjects only)

• Secondary Efficacy Endpoint -- Technical Success

  30 days

• Secondary Efficacy Endpoint -- Clinical Utility Measures

  Perioperative/Periprocedural

• Secondary Efficacy Endpoint -- Secondary interventions

  30 days, 6 months, annually to 5-years; annually to 10-years (stent-fracture subjects only)

• Secondary Efficacy Endpoint -- Device-Related Events

  30 days, 6 months, and annually to 5-years; annually to 10-years (stent-fracture subjects only)

Study Arms (1)

Treovance

EXPERIMENTAL

Subjects who receive the Treovance stent-graft

Device: Subjects who receive the Treovance stent-graft

Interventions

Subjects who receive the Treovance stent-graft DEVICE

Eligible subjects will be implanted with the Treovance Stent-Graft

Also known as: Treovance Abdominal Stent-Graft with Navitel Delivery System

Treovance

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be between the ages of 18 and 85
• 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
• 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
• 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
• Subject's infrarenal landing neck must meet the vessel size requirements specified in the instructions for use (IFU) for the corresponding devices
• Subject must have lowest renal artery at least 9 cm from the aortic bifurcation
• 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
• Subject's distal iliac landing neck must meet the vessel size requirements specified for the corresponding devices in the IFU
• Subject must have a total treatment length of at least 13 cm
• 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
• 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
• Subject must have adequate renal function to tolerate required follow-up contrast-enhanced CTs
• 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.
• Subject or Legally Authorized Representative (LAR) must agree to sign Informed Consent Form

You may not qualify if:

• Subject is pregnant or lactating
• Subject has a dissection in abdominal aorta, ruptured aneurysm, or symptomatic aneurysm (as determined by treating physician)
• Subject has a patent inferior mesenteric artery that cannot be sacrificed and an occluded or stenotic celiac and/or superior mesenteric artery
• Implant procedure as planned does not allow for at least one patent hypogastric artery left intact, unless both are occluded on pre-op imaging
• Subject has a lesion that cannot be crossed by a guide wire
• Proximal neck cannot increase by more than 10% over 15mm or more than 7% over 10mm; i.e., no trapezoidal necks
• 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)
• Subject has had a stroke or myocardial infarction within 6 months of the planned treatment date
• Subject has chronic obstructive pulmonary disease requiring routine need for oxygen therapy outside the hospital setting (e.g., daily or nightly home use)
• Subject has an active systemic infection or is suspected of having an active systemic infection (e.g.,AIDS/HIV, sepsis)
• 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
• Subject has connective tissue disease (e.g., Marfan's syndrome)
• Subject has a mycotic aneurysm
• Subject has significant or circumferential calcification or mural thrombus in the proximal aortic neck
• Subject has significant or circumferential calcification or mural thrombus in the distal iliac landing zone

Sponsors & Collaborators

• Bolton Medical: lead

Study Sites (29)

University of Alabama-Birmingham

Birmingham, Alabama, 35294, United States

Location

Arizona Heart Institute

Phoenix, Arizona, 85006, United States

Location

Danbury Hospital

Danbury, Connecticut, 06810, United States

Location

Lynn Heart and Vascular Institute

Boca Raton, Florida, 33486, United States

Location

Northside Hospital Heart & Vascular Institute

Atlanta, Georgia, 30342, United States

Location

Presence Medical Center -- Christie Clinic

Champaign, Illinois, 61820, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Affiliated Surgeons of Rockford Memorial Hospital

Rockford, Illinois, 61103, United States

Location

University of Iowa Hospital and Clinic

Iowa City, Iowa, 52242, United States

Location

Tufts University Medical Center

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Massachusetts

Worcester, Massachusetts, 01655, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Community Care (previously Albany Medical Center)

Albany, New York, 12205, United States

Location

Buffalo General Medical Center

Buffalo, New York, 14203, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

University of Rochester -- Strong Memorial Hospital

Rochester, New York, 14623, United States

Location

Stony Brook Medical Center

Stony Brook, New York, 11794-8191, United States

Location

Mission Hospital

Asheville, North Carolina, 28801, United States

Location

East Carolina University / Pitt County Memorial Hospital

Greenville, North Carolina, 27834, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Temple University School of Medicine

Philadelphia, Pennsylvania, 19140, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

York Hospital

York, Pennsylvania, 17403, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02905, United States

Location

North Central Heart (Avera Heart Hospital)

Sioux Falls, South Dakota, 51108, United States

Location

Sanford University of South Dakota Medical Center

Sioux Falls, South Dakota, 57117, United States

Location

Sentara Vascular Specialists

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Aneurysm

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Matthew Eagleton, MD

  Cleveland Clinic Foundaton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: AAA Device

Study Record Dates

• First Submitted: November 6, 2013
• First Posted: December 12, 2013
• Study Start: November 23, 2013
• Primary Completion: March 20, 2017
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 28, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (29)