Endurant Evo US Clinical Trial

NCT02393716 | Terminated Results DMC FDA Device

• 1 other identifier: 10173341DOC
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 14

Brief Summary

The purpose of this study is to demonstrate that the Endurant Evo Abdominal Aortic Aneurysm (AAA) stent graft system is safe and effective for endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms.

Conditions

Abdominal Aortic Aneurysm; AAA

Outcome Measures

Primary Outcomes (2)

• The Percentage of Subjects Experiencing a Major Adverse Event (MAE) Within 30 Days Post-implantation.

  The percentage of subjects experiencing a Major Adverse Event (MAE) within 30 days post-implantation. MAEs include the occurrence of any of the following events: * All-cause mortality * Bowel ischemia * Myocardial infarction * Paraplegia * Procedural blood loss ≥1000 cc * Renal failure * Respiratory failure * Stroke

  30-days

• The Percentage of Subjects With Both Technical Success at the Time of Index Procedure and Treatment Success at 12-months Post-implantation.

  Successful aneurysm treatment was achieved based on the following criteria: Technical success at the index procedure (as assessed intra-operatively), defined as successful delivery and deployment of the Endurant Evo AAA Stent graft system in the planned location and with no unintentional coverage of both internal iliac arteries or any visceral aortic branches and with successful removal of the delivery system AND Treatment success consisting of freedom from: * AAA diameter increase, defined as \> 5 mm increase in maximum diameter as measured on computed tomography (CT) scan or magnetic resonance angiography/magnetic resonance imaging (MRA/MRI) at 12-month follow-up as compared to 1-month imaging * Types I and III endoleaks at 12-month follow-up including those requiring intervention through 12 months * Aneurysm rupture within 365 days * Conversion to surgery within 365 days * Stent graft migration resulting in a serious adverse event or requiring seco

  12-months

Secondary Outcomes (13)

• All-cause Mortality

  within 30, 183, and 365 days

• Aneurysm-related Mortality (ARM)

  within 30, 183, and 365 days

• Secondary Procedures to Correct Type I and III Endoleaks

  within 183, and 365 days

• Secondary Procedures

  within 183, and 365 days

• Serious Adverse Events

  within 30, 183, and 365 days

Study Arms (1)

Endovascular repair

OTHER

Endurant Evo AAA Stent Graft System

Device: Endurant Evo AAA Stent Graft System; Procedure: Endovascular aneurysm repair (EVAR)

Interventions

Endurant Evo AAA Stent Graft System DEVICE

Endovascular repair

Endovascular aneurysm repair (EVAR) PROCEDURE

Endovascular repair

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 understands and voluntarily has signed and dated the Informed Consent approved by the Sponsor and by the Ethics Committee/Institutional Review Board
• Subject is able and willing to comply with the protocol and to adhere to the follow-up requirements
• Subject is a suitable candidate for elective surgical repair of AAA as evaluated by American Society of Anesthesiologists (ASA) Physical Status Classification System I, II, or III
• Subject has an infrarenal abdominal aortic or aortoiliac aneurysm characterized by one or more of the following:
• Aneurysm is \>5 cm in diameter (diameter measured is perpendicular to the line of flow)
• Aneurysm is 4 - 5 cm in diameter and has increased in size ≥0.5 cm within the previous 6 months
• Subject meets all the following anatomical criteria as demonstrated on contrast-enhanced computed tomography (CTA) or magnetic resonance angiography (MRA) imaging:
• Proximal neck length of ≥ 10 mm with ≤ 60° infrarenal and ≤ 45° suprarenal neck angulation or Proximal neck length of ≥ 15 mm with ≤ 75° infrarenal and ≤ 60° suprarenal neck angulation
• Subject has vascular dimensions, e.g., aortic and iliac diameters, lengths from renal arteries to iliac bifurcation and hypogastric arteries, in the range of sizes available for the Endurant Evo AAA stent graft system (measured intima to intima) and within the sizing recommendations (refer to Endurant Evo AAA stent graft system Instructions for Use (IFU))
• Subject has a proximal aortic neck diameter ≥ 18 mm and ≤ 32 mm
• The distal fixation center of the iliac arteries must have a diameter ≥ 7 mm and ≤ 25 mm bilaterally for the bifurcation and unilaterally for the Aorto-uni-iliac stent graft (AUI)
• Subject has documented imaging evidence of at least one patent iliac and one femoral artery, or can tolerate a vascular conduit that allows introduction of the Endurant Evo AAA stent graft system
• Subject has distal non-aneurysmal iliac (cylindrical) fixation length ≥20 mm bilateral for the bifurcation and unilaterally for the AUI

You may not qualify if:

• Subject has a life expectancy ≤1 year
• Subject is participating in another investigational drug or device study which would interfere with the endpoints and follow-ups of this study
• Subject is pregnant
• Subject has an aneurysm that is:
• Suprarenal/pararenal/juxtarenal
• Isolated ilio-femoral
• Mycotic
• Inflammatory
• Pseudoaneurysm
• Dissecting
• Ruptured
• Leaking but not ruptured
• Subject requires emergent aneurysm treatment
• Subject has a known, untreated thoracic aneurysm \>4.5 cm in diameter at the time of screening
• Subject has been previously treated for an abdominal aortic aneurysm

Sponsors & Collaborators

• Medtronic Cardiovascular: lead

Study Sites (14)

Kaiser Permanente Zion Medical Center

San Diego, California, 92123, United States

Location

Stanford Hospital & Clinics

Stanford, California, 94305-5330, United States

Location

Medstar Heart & Vascular Institute

Washington D.C., District of Columbia, 20010-3017, United States

Location

Maine Medical Center

Portland, Maine, 04102-3134, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215-5324, United States

Location

University of Michigan Health Sysem

Ann Arbor, Michigan, 48109, United States

Location

Long Island Jewish Northshore University Hospital

New Hyde Park, New York, 11040, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219-2906, United States

Location

UPMC Pinnacle Harrisburg Campus

Harrisburg, Pennsylvania, 17101-2010, United States

Location

Erlanger Medical Center

Chattanooga, Tennessee, 37403-2147, United States

Location

Heart Hospital of Austin

Austin, Texas, 78756-4080, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Providence Sacred Heart Medical Center

Spokane, Washington, 99204-2307, United States

Location

Aurora St. Lukes Medial Center

Milwaukee, Wisconsin, 53215-3669, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Blood Vessel Prosthesis Implantation; Vascular Grafting; Minimally Invasive Surgical Procedures; Prosthesis Implantation

Results Point of Contact

• Title: Kristel Wittebols Sr. Clinical Research Director
• Organization: Medtronic

kristel.wittebols@medtronic.com

31 (0)43-3566566

Study Officials

• Gilbert Upchurch, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: March 6, 2015
• First Posted: March 19, 2015
• Study Start: April 1, 2015
• Primary Completion: June 25, 2021
• Study Completion: June 25, 2021
• Last Updated: December 6, 2022
• Results First Posted: December 6, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)