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

NACompletedINTERVENTIONAL
Enrollment

455

Participants

Timeline

Start Date

March 31, 2015

Primary Completion Date

October 31, 2018

Study Completion Date

October 31, 2022

Conditions
Abdominal Aortic Aneurysm
Interventions
DEVICE

AFX EVAR AAA Graft System

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

DEVICE

FDA Approved EVAR AAA Graft Systems

Trial Locations (56)

12208

The Vascular Group, Albany

14215

VA Western New York Healthcare System, Buffalo

17822

Geisinger Medical Center, Danville

19104

Hospital of the University of Pennsylvania, Philadelphia

19107

Thomas Jefferson University, Philadelphia

21201

VA Maryland Health Care System, Baltimore

21801

Peninsula Regional Medical Center, Salisbury

23507

Sentara Vascular Specialists, Norfolk

27157

Wake Forest, Winston-Salem

30281

Peachtree Vascular Specialists, Stockbridge

30303

Emory/Grady, Atlanta

31201

Navicent Health Medical Center, Macon

32224

Mayo Jacksonville, Jacksonville

32803

Vascular Institute of Central Florida, Orlando

33140

Mount Sinai Medical Center, Miami Beach

33606

USF/Tampa VA, Tampa

34232

Sarasota Vascular Specialists, Sarasota

35630

Eliza Coffee Medical Center, Florence

35801

Huntsville Hospital, Huntsville

38801

North MS Medical Center, Tupelo

39402

Hattiesburg Clinic, Hattiesburg

40207

Surgical Care Associates, Louisville

44094

Neo Vascular (Lake West), Willoughby

44106

University Hospitals Cleveland Medical Center, Cleveland

44195

Cleveland Clinic, Cleveland

45429

Innovation Center, Kettering Health Network, Kettering

46237

Franciscan - St. Francis Hospital, Indianapolis

46845

Parkview Research Center, Fort Wayne

48097

Yale University, New Haven

48197

St. Joseph Mercy Ann Arbor, Ypsilanti

50266

The Iowa Clinic Cardiovascular Services, West Des Moines

52246

University of Iowa Healthcare, Iowa City

53226

Medical College of Wisconsin, Milwaukee

53295

Clement J. Zablocki VA Medical Center, Milwaukee

53792

University of Wisconsin, Madison

57108

North Central Heart, Sioux Falls

60190

Cadence Physician Group, Winfield

61110

Hartford Hospital, New Britain

62701

Prairie Education & Research Cooperative, Springfield

63124

Saint Louis University, St Louis

64116

Kansas City Vascular, North Kansas City

65212

University of Missouri, Columbia

70808

Cardiovascular Research Foundation of Louisiana, Baton Rouge

70809

Baton Rouge Vascular Specialty Center, Baton Rouge

72205

Central Arkansas Veteran's Healthcare System, Little Rock

77030

University of Texas Health, Houston

78756

Cardiothoracic & Vascular Surgeons, Austin

80907

Penrose St. Francis Health, Colorado Springs

85006

Banner Good Samaritan Hospital, Phoenix

85745

Carondelet Heart and Vascular Institute, Tucson

90822

Long Beach VA Hospital, Long Beach

95051

Kaiser - Santa Clara, Santa Clara

95816

Sacramento Vascular Sugeons, Sacramento

98664

Peacehealth Southwest Medical Center, Vancouver

02114

Massachusetts General Hospital, Boston

05401

University of Vermont Medical Center, Burlington

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Endologix

INDUSTRY