Post-Market Study to Assess Outcomes of Patients Treated With AFX System Compared to Other EVAR Devices

NCT02407457 | Completed Results FDA Device

• 1 other identifier: CP-0011
• Study Type: interventional
• Target: 455
• Locations: 1 country
• Sites: 56

Brief Summary

The objective of this post-market trial is to evaluate Endologix AFX endovascular AAA system with anatomical fixation against other approved Endovascular systems with proximal fixation. Multiple U.S clinical centers will be involved in the trial to include a broad range of experience. Imaging data will be evaluated by an independent core lab.

Conditions

Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Absence of Aneurysm Related Complications (ARC)

  ARC is a composite of the most relevant EVAR outcomes and includes: * Peri-Operative Death (\< 30 days) * Rupture * Conversion to OSR * Endoleaks; post-operative * Migration (≥ 10mm) * Aneurysm Enlargement (≥ 5mm) * Endograft Limb Occlusions * Reinterventions for device- or aneurysm-related complications

  1 year

Secondary Outcomes (14)

• The Number of MAEs

  At 30 days, 12 months, and annually up to five years

• The Number of Participants With Aneurysm Related Complications (ARC)

  Post 12 Months up to Five Years

• The Number of Participants With Aneurysm Related Mortality

  Up to Five Years

• Number of Type Ia Endoleaks

  Up to Five Years

• Number of Type Ib Endoleaks

  Up to Five Years

Study Arms (2)

AFX EVAR AAA Graft System

ACTIVE COMPARATOR

Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.

Device: AFX EVAR AAA Graft System

FDA Approved EVAR AAA Graft Systems

ACTIVE COMPARATOR

Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.

Device: FDA Approved EVAR AAA Graft Systems

Interventions

AFX EVAR AAA Graft System DEVICE

Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.

AFX EVAR AAA Graft System

FDA Approved EVAR AAA Graft Systems DEVICE

FDA Approved EVAR AAA Graft Systems

Eligibility Criteria

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

You may qualify if:

• Male or female at least 18 years old
• Subjects with minimum of 2 year life expectancy
• Subjects have signed the informed consent document for data release
• Subjects with infrarenal AAA who are assessed by the Investigator to be eligible for endovascular Abdominal Aortic Aneurysm Repair with the trial devices.

You may not qualify if:

• Currently participating in another study where primary endpoint has not been reached yet
• Known allergy to any of the device components
• Pregnant (females of childbearing potential only)
• Subjects with pre-existing EVAR, e.e. in need of repair/intervention of a previously failed EVAR

Sponsors & Collaborators

• Endologix: lead

Study Sites (56)

Eliza Coffee Medical Center

Florence, Alabama, 35630, United States

Location

Huntsville Hospital

Huntsville, Alabama, 35801, United States

Location

Banner Good Samaritan Hospital

Phoenix, Arizona, 85006, United States

Location

Carondelet Heart and Vascular Institute

Tucson, Arizona, 85745, United States

Location

Central Arkansas Veteran's Healthcare System

Little Rock, Arkansas, 72205, United States

Location

Long Beach VA Hospital

Long Beach, California, 90822, United States

Location

Sacramento Vascular Sugeons

Sacramento, California, 95816, United States

Location

Kaiser - Santa Clara

Santa Clara, California, 95051, United States

Location

Penrose St. Francis Health

Colorado Springs, Colorado, 80907, United States

Location

Hartford Hospital

New Britain, Connecticut, 61110, United States

Location

Yale University

New Haven, Connecticut, 48097, United States

Location

Mayo Jacksonville

Jacksonville, Florida, 32224, United States

Location

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Vascular Institute of Central Florida

Orlando, Florida, 32803, United States

Location

Sarasota Vascular Specialists

Sarasota, Florida, 34232, United States

Location

USF/Tampa VA

Tampa, Florida, 33606, United States

Location

Emory/Grady

Atlanta, Georgia, 30303, United States

Location

Navicent Health Medical Center

Macon, Georgia, 31201, United States

Location

Peachtree Vascular Specialists

Stockbridge, Georgia, 30281, United States

Location

Prairie Education & Research Cooperative

Springfield, Illinois, 62701, United States

Location

Cadence Physician Group

Winfield, Illinois, 60190, United States

Location

Parkview Research Center

Fort Wayne, Indiana, 46845, United States

Location

Franciscan - St. Francis Hospital

Indianapolis, Indiana, 46237, United States

Location

University of Iowa Healthcare

Iowa City, Iowa, 52246, United States

Location

The Iowa Clinic Cardiovascular Services

West Des Moines, Iowa, 50266, United States

Location

Surgical Care Associates

Louisville, Kentucky, 40207, United States

Location

Cardiovascular Research Foundation of Louisiana

Baton Rouge, Louisiana, 70808, United States

Location

Baton Rouge Vascular Specialty Center

Baton Rouge, Louisiana, 70809, United States

Location

VA Maryland Health Care System

Baltimore, Maryland, 21201, United States

Location

Peninsula Regional Medical Center

Salisbury, Maryland, 21801, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

St. Joseph Mercy Ann Arbor

Ypsilanti, Michigan, 48197, United States

Location

Hattiesburg Clinic

Hattiesburg, Mississippi, 39402, United States

Location

North MS Medical Center

Tupelo, Mississippi, 38801, United States

Location

University of Missouri

Columbia, Missouri, 65212, United States

Location

Kansas City Vascular

North Kansas City, Missouri, 64116, United States

Location

Saint Louis University

St Louis, Missouri, 63124, United States

Location

The Vascular Group

Albany, New York, 12208, United States

Location

VA Western New York Healthcare System

Buffalo, New York, 14215, United States

Location

Wake Forest

Winston-Salem, North Carolina, 27157, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Innovation Center, Kettering Health Network

Kettering, Ohio, 45429, United States

Location

Neo Vascular (Lake West)

Willoughby, Ohio, 44094, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

North Central Heart

Sioux Falls, South Dakota, 57108, United States

Location

Cardiothoracic & Vascular Surgeons

Austin, Texas, 78756, United States

Location

University of Texas Health

Houston, Texas, 77030, United States

Location

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

Sentara Vascular Specialists

Norfolk, Virginia, 23507, United States

Location

Peacehealth Southwest Medical Center

Vancouver, Washington, 98664, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Clement J. Zablocki VA Medical Center

Milwaukee, Wisconsin, 53295, United States

Location

Related Publications (7)

• Prinssen M, Verhoeven EL, Buth J, Cuypers PW, van Sambeek MR, Balm R, Buskens E, Grobbee DE, Blankensteijn JD; Dutch Randomized Endovascular Aneurysm Management (DREAM)Trial Group. A randomized trial comparing conventional and endovascular repair of abdominal aortic aneurysms. N Engl J Med. 2004 Oct 14;351(16):1607-18. doi: 10.1056/NEJMoa042002.

  PMID: 15483279 BACKGROUND

• Volodos' NL, Karpovich IP, Shekhanin VE, Troian VI, Iakovenko LF. [A case of distant transfemoral endoprosthesis of the thoracic artery using a self-fixing synthetic prosthesis in traumatic aneurysm]. Grudn Khir. 1988 Nov-Dec;(6):84-6. No abstract available. Russian.

  PMID: 3220297 BACKGROUND

• Greenhalgh RM, Brown LC, Kwong GP, Powell JT, Thompson SG; EVAR trial participants. Comparison of endovascular aneurysm repair with open repair in patients with abdominal aortic aneurysm (EVAR trial 1), 30-day operative mortality results: randomised controlled trial. Lancet. 2004 Sep 4-10;364(9437):843-8. doi: 10.1016/S0140-6736(04)16979-1.

  PMID: 15351191 BACKGROUND

• Brown LC, Greenhalgh RM, Thompson SG, Powell JT; EVAR Trial Participants. Does EVAR alter the rate of cardiovascular events in patients with abdominal aortic aneurysm considered unfit for open repair? Results from the randomised EVAR trial 2. Eur J Vasc Endovasc Surg. 2010 Apr;39(4):396-402. doi: 10.1016/j.ejvs.2010.01.002. Epub 2010 Jan 21.

  PMID: 20096611 BACKGROUND

• Stroupe KT, Lederle FA, Matsumura JS, Kyriakides TC, Jonk YC, Ge L, Freischlag JA; Open Versus Endovascular Repair (OVER) Veterans Affairs Cooperative Study Group. Cost-effectiveness of open versus endovascular repair of abdominal aortic aneurysm in the OVER trial. J Vasc Surg. 2012 Oct;56(4):901-9.e2. doi: 10.1016/j.jvs.2012.01.086. Epub 2012 May 27.

  PMID: 22640466 BACKGROUND

• De Bruin JL, Baas AF, Buth J, Prinssen M, Verhoeven EL, Cuypers PW, van Sambeek MR, Balm R, Grobbee DE, Blankensteijn JD; DREAM Study Group. Long-term outcome of open or endovascular repair of abdominal aortic aneurysm. N Engl J Med. 2010 May 20;362(20):1881-9. doi: 10.1056/NEJMoa0909499.

  PMID: 20484396 BACKGROUND

• Kwolek CJ, Ouriel K, Stucky FS, Rao VK, Pons PJ, Wilson SE, Kujath SW. Five-year results of the LEOPARD trial of commercially available endografts. J Vasc Surg. 2023 Aug;78(2):324-332.e2. doi: 10.1016/j.jvs.2023.04.011. Epub 2023 Apr 15.

  PMID: 37068528 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Sharone Trifskin
• Organization: Endologix, Inc.

strifskin@endologix.com

949-599-8860

Study Officials

• Christopher Kwolek, MD

  Endologix

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: March 6, 2015
• First Posted: April 3, 2015
• Study Start: March 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2022
• Last Updated: October 1, 2024
• Results First Posted: September 21, 2020

Record last verified: 2024-09

Locations

US (56)