Endurant Bifurcated and Aorto-Uni-Iliac (AUI) Stent Graft System

NCT00705718 | Completed Results DMC

• 1 other identifier: Medtronic - 089
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 30

Brief Summary

To demonstrate safety and effectiveness of the Endurant Stent Graft in the treatment of Abdominal Aortic or Aorto-Uni-Iliac Aneurysms.

Conditions

Abdominal Aortic Aneurysms

Keywords

Endurant Stent Graft System; Abdominal Aortic Aneurysms; Endovascular Treatment

Outcome Measures

Primary Outcomes (4)

• Primary Safety Endpoint (Freedom From MAEs Within 30 Days of Index Procedure)

  The primary safety endpoint is composite defined as the proportion of subjects free from major adverse events (MAE) within 1 month (day 0 - Day 30)of implant is non-inferior to the proportion of subjects free from MAEs in the Talent Control Group. The endpoint is defined as the proportion of subjects free from occurence of a MAE within 1 month of the implantation of the Endurant Stent Graft. The major adverse events composite endpoint which will be evaluated at 1 month post implant includes the occurrence of any of the following events. * All-Cause Mortality * Bowel Ischemia * Myocardial Infarction * Paraplegia * Procedural Blood Loss \> or equal to 1000 cc * Renal Failure * Respiratory Failure * Stroke

  30 days (Safety)

• Major Adverse Events Within 30 Days of Index Procedure

  The primary safety endpoint is composite defined as the proportion of subjects free from major adverse events (MAE) within 1 month (day 0 - Day 30)of implant is non-inferior to the proportion of subjects free from MAEs in the Talent Control Group. The endpoint is defined as the proportion of subjects free from occurence of a MAE within 1 month of the implantation of the Endurant Stent Graft. The major adverse events composite endpoint which will be evaluated at 1 month post implant includes the occurrence of any of the following events. * All-Cause Mortality * Bowel Ischemia * Myocardial Infarction * Paraplegia * Procedural Blood Loss \> or equal to 1000 cc * Renal Failure * Respiratory Failure * Stroke

  30 days

• Primary Effectiveness Endpoint (Technical Success)

  Technical success defined as successful delivery and deployment of the stent graft in the planned location and with no unintentional coverage of both the internal iliac arteries or any visceral aortic branches and with removal of the system. Technical success was assessed intra-operatively.

  Intra-operatively

• Primary Effectiveness Endpoint (Treatment Success)

  Treatment success is defined as Technical success and the following: * Freedom from AAA diameter increased, defined as \>5 mm increase in maximum diameter as measured on CT scan (or MRA/MRI) at 12 months as compared to 1 month * Freedom from Types I and III endoleaks at 12 months including those requiring intervention through 12 months * Freedom from aneurysm rupture through 12 months * Freedom from conversion to surgery through 12 months * Freedom from stent graft migrations resulting in a serious adverse event or requiring secondary intervention through 12 months * Freedom from stent graft occlusion at 12 months

  12 months

Secondary Outcomes (2)

• Secondary Endpoints - Safety Evaluation

  12 months

• Secondary Endpoint - Effectiveness Evaluation

  12 months

Study Arms (2)

Endurant Bifurcated arm

EXPERIMENTAL

The Bifurcated arm includes subjects who have received a bifurcated device. The Endurant Stent Graft System Bifurcated device is administered to treat patients with an Abdominal Aortic Aneurysm.

Device: Endurant Stent Graft System

Endurant AUI arm

EXPERIMENTAL

The AUI arm includes subjects who have received an AUI device. The Endurant Stent Graft System AUI device is administered to treat patients with an Abdominal Aortic Aneurysm.

Device: Endurant Stent Graft System

Interventions

Endurant Stent Graft System DEVICE

Abdominal Aortic Aneurysm Repair

Also known as: Endovascular treatment of Abdominal Aortic Aneurysm

Endurant AUI arm; Endurant Bifurcated arm

Eligibility Criteria

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

You may qualify if:

• Subject is ≥ 18 years old.
• Subject (or Subject's legal representative) understands and voluntarily has signed and dated an Informed Consent document approved by the Sponsor and by the Institutional Review Board.
• Subject is able and willing to comply with the protocol and undergo follow-up requirements.
• Subject is a suitable candidate for elective surgical repair of AAA by as evaluated by American Society of Anesthesiologists (ASA) Physical Status Classification System I, II, III, or IV
• Subject has an abdominal aortic or aortoiliac aneurysm characteristics that meet protocol parameter
• Subject meets all the protocol anatomical criteria\* as demonstrated on contrast-enhanced CT or MRA
• Subject has vascular dimensions in the range of sizes available for the Endurant Stent Graft
• Subject has documented imaging evidence of at least 1 patent iliac and 1 femoral artery, or can tolerate a vascular conduit that allows introduction of the device.
• Subject's native vessel anatomy is more suited for the introduction and/ or deployment of an Endurant Uni-Iliac Stent Graft System.

You may not qualify if:

• Subject has a life expectancy \< 1 year
• Subject is participating in another investigational drug or device study
• Subject requires emergent aneurysm treatment
• Subject is a female of childbearing potential in whom pregnancy cannot be excluded.
• Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment.
• Subject is morbidly obese (body mass index ≥ 40 kg/m2) or has other documented clinical conditions that severely inhibit radiographic visualization of the aorta.

Sponsors & Collaborators

• Medtronic Cardiovascular: lead

Study Sites (30)

University of Alabama Hospitals

Birmingham, Alabama, 35294, United States

Location

Arizona Heart Institute

Phoenix, Arizona, 85006, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Wellstar Kennestone Hospital

Marietta, Georgia, 30106, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Good Samaritan Hospital

Downers Grove, Illinois, 60515, United States

Location

Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

St. John's Mercy Medical Center

St Louis, Missouri, 63141, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

Sisters of Charity Hospital

Buffalo, New York, 14214, United States

Location

NYU Hospitals Center

New York, New York, 10016, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Mission Hospitals

Asheville, North Carolina, 28801, United States

Location

Mid Carolina Presbyterian Hospital

Charlotte, North Carolina, 28204, United States

Location

Lindner Clinical Trial Center

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Jobst Vascular Center

Toledo, Ohio, 43606, United States

Location

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, 19104, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Sanford Research

Sioux Falls, South Dakota, 57104, United States

Location

Baptist Memorial Hospital Memphis

Memphis, Tennessee, 38120, United States

Location

Premier Surgical Associates

Powell, Tennessee, 37849, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Scott & White Memorial Medical Center

Temple, Texas, 76508, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Limitations and Caveats

Adverse Events and Serious Adverse Events listed in ClinicalTrials.gov were re-coded, using MeDRA codes. To do so, events were reclassified. As a result, data in listings may not match those in Clinical Update reports, SSEDs, or Instructions for Use.

Results Point of Contact

• Title: Karla Betz, Principal Clinical Research Specialist
• Organization: Medtronic

karla.h.betz@medtronic.com

763-526-2737

Study Officials

• Michel S Makaroun, MD

  Division of Vascular Surgery University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2008
• First Posted: June 26, 2008
• Study Start: June 1, 2008
• Primary Completion: September 1, 2012
• Study Completion: September 26, 2016
• Last Updated: November 3, 2021
• Results First Posted: March 21, 2014

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (30)