Endurant Stent Graft System Post Approval Study (ENGAGE PAS)

NCT01379222 | Completed Results FDA Device

• 1 other identifier: 10012289
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 24

Brief Summary

The purpose of the study is to demonstrate the long term safety and effectiveness of the Endurant Stent Graft System for the endovascular treatment of infrarenal abdominal aortic aneurysms in a post-approval environment, through the endpoints established in this protocol. The clinical objective of the study is to evaluate the long term safety and effectiveness of the Endurant Stent Graft System assessed at 5 years through freedom from Aneurysm-Related Mortality (ARM).

Conditions

Aortic Aneurysm, Abdominal

Keywords

AAA; Abdominal Aortic Aneurysm; EVAR; Endovascular aneurysm repair

Outcome Measures

Primary Outcomes (1)

• Freedom From Aneurysm-related Mortality Rate (ARM) at 5 Years (1826 Days)

  Aneurysm-Related Mortality (ARM) is defined as death from rupture of the abdominal aortic aneurysm or from any procedure intended to treat the Abdominal Aortic Aneurysm (AAA). If a death occurred within 30 days of any procedure intended to treat the AAA, then it is presumed to be aneurysm related unless there is evidence to the contrary. Deaths occurring after 30 days of any procedure intended to treat the AAA that are procedure-related should be aneurysm related. \> All deaths will be adjudicated by a Clinical Events Committee (CEC) to determine device, procedure and/or AAA relatedness.

  5 years

Study Arms (1)

ENGAGE PAS De Novo Subjects

EXPERIMENTAL

The Endurant Stent Graft System Bifurcated device is administered to patients diagnosed with an abdominal aortic or aortoiliac aneurysm who are considered candidates for endovascular repair, per the FDA approved Instructions For Use (IFU).

Device: Endurant Stent Graft System

Interventions

Endurant Stent Graft System DEVICE

The Endurant Stent Graft System is designed to treat infrarenal abdominal aortic aneurysms using an endovascular approach. When placed within the aneurysm, the Endurant Stent Graft is designed to provide a permanent, alternative conduit for blood flow within the patient's vasculature by excluding the aneurysmal sac from blood flow and pressure.

ENGAGE PAS De Novo Subjects

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years
• Indication for elective surgical repair of abdominal aortic aneurysm (AAA) with an endovascular stent graft in accordance with the applicable guidelines on endovascular interventions and the Instructions for Use of the Endurant Stent Graft System
• Signed consent form. The subject or legal representative has been informed of the nature of the trial and has consented to participate and authorized the collection and release of his medical information
• Intention to electively implant the Endurant Stent Graft System
• Ability and willingness to comply with the Clinical Investigational Plan (CIP).

You may not qualify if:

• High probability of non-adherence to physician's follow-up requirements
• Current participation in a concurrent trial which may confound study results
• Female of childbearing potential in whom pregnancy cannot be excluded or who is lactating.

Sponsors & Collaborators

• Medtronic Cardiovascular: lead
• Duke Clinical Research Institute: collaborator

Study Sites (24)

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Stanford Hospital & Clinics

Stanford, California, 94305-5330, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06510-3220, United States

Location

Bayfront Medical Center

St. Petersburg, Florida, 33701-4814, United States

Location

Medical Center of Central Georgia (MCCG)

Macon, Georgia, 31201-2102, United States

Location

Mercy Hospital and Medical Center

Chicago, Illinois, 60616-2332, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62702-4933, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215-5324, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756-1000, United States

Location

Morristown Memorial Hospital

Morristown, New Jersey, 07960-6136, United States

Location

WakeMed Health & Hospitals

Raleigh, North Carolina, 27610-1231, United States

Location

Novant Health Forsyth Medical Center

Winston-Salem, North Carolina, 27103-3013, United States

Location

Sanford Medical Center Fargo

Fargo, North Dakota, 58122, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219-2906, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106-1716, United States

Location

Lehigh Valley Hospital - Cedar Crest

Allentown, Pennsylvania, 18103, United States

Location

University of Pittsburgh Medical Center UPMC Shadyside

Pittsburgh, Pennsylvania, 15232-1311, United States

Location

Physicians Regional Medical Center

Knoxville, Tennessee, 37917-4556, United States

Location

Parkwest Medical Center

Knoxville, Tennessee, 37923-4325, United States

Location

Baylor Jack and Jane Hamilton Heart and Vascular Hospital

Dallas, Texas, 75226-1316, United States

Location

CHI Saint Luke's Health - Baylor Saint Luke's Medical Center

Houston, Texas, 77030-2604, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, 22908-0816, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042-3307, United States

Location

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, 53215-3669, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Thushari Alahapperuma
• Organization: Medtronic

thushari.r.alahapperuma@medtronic.com

763.526.8119

Study Officials

• Marc Schermerhorn, MD

  Beth Israel Deaconess Medical Center

  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: June 21, 2011
• First Posted: June 23, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: October 29, 2021
• Results First Posted: February 4, 2019

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (24)