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

Abdominal Aortic Aneurysm Clinical Trial

— LEOPARD  

Official title:

Multicenter, Post-Market Study to Assess Outcomes of Patients Treated With the AFX System Compared to Other EVAR Devices for Endovascular Abdominal Aortic Aneurysm Repair: LEOPARD

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02407457
• Other study ID #: CP-0011
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 2015
• Est. completion date: September 2022

Study information

• Verified date: November 2021
• Source: Endologix
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This trial is a prospective, randomized, multi-center trial, intended to evaluate the outcomes of contemporary EVAR (Endovascular Aneurysm Repair) in a real world population. The trial is designed to compare the anatomically stabilized AFX Endograft System to a reference group of proximally fixated EVAR devices. Patients will be randomized between the two groups.

Randomization will be 1:1. Each investigator will select one comparator device of their choice before enrolling the first patient. The study will sequentially evaluate non-inferiority and superiority hypotheses.

Up to 80 sites with experience in EVAR and up to 800 subjects will participate in this study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 455
• Est. completion date: September 2022
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female at least 18 years old

2. Subjects with minimum of 2 year life expectancy

3. Subjects have signed the informed consent document for data release

4. Subjects with infrarenal AAA who are assessed by the Investigator to be eligible for endovascular Abdominal Aortic Aneurysm Repair with the trial devices.

Exclusion Criteria:

1. Currently participating in another study where primary endpoint has not been reached yet

2. Known allergy to any of the device components

3. Pregnant (females of childbearing potential only)

4. Subjects with pre-existing EVAR, e.e. in need of repair/intervention of a previously failed EVAR

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Device:
• AFX EVAR AAA Graft System
Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.
• FDA Approved EVAR AAA Graft Systems

Locations

Country	Name	City	State
United States	The Vascular Group	Albany	New York
United States	Emory/Grady	Atlanta	Georgia
United States	Cardiothoracic & Vascular Surgeons	Austin	Texas
United States	VA Maryland Health Care System	Baltimore	Maryland
United States	Baton Rouge Vascular Specialty Center	Baton Rouge	Louisiana
United States	Cardiovascular Research Foundation of Louisiana	Baton Rouge	Louisiana
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	VA Western New York Healthcare System	Buffalo	New York
United States	University of Vermont Medical Center	Burlington	Vermont
United States	Cleveland Clinic	Cleveland	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Penrose St. Francis Health	Colorado Springs	Colorado
United States	University of Missouri	Columbia	Missouri
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Eliza Coffee Medical Center	Florence	Alabama
United States	Parkview Research Center	Fort Wayne	Indiana
United States	Hattiesburg Clinic	Hattiesburg	Mississippi
United States	University of Texas Health	Houston	Texas
United States	Huntsville Hospital	Huntsville	Alabama
United States	Franciscan - St. Francis Hospital	Indianapolis	Indiana
United States	University of Iowa Healthcare	Iowa City	Iowa
United States	Mayo Jacksonville	Jacksonville	Florida
United States	Innovation Center, Kettering Health Network	Kettering	Ohio
United States	Central Arkansas Veteran's Healthcare System	Little Rock	Arkansas
United States	Long Beach VA Hospital	Long Beach	California
United States	Surgical Care Associates	Louisville	Kentucky
United States	Navicent Health Medical Center	Macon	Georgia
United States	University of Wisconsin	Madison	Wisconsin
United States	Mount Sinai Medical Center	Miami Beach	Florida
United States	Clement J. Zablocki VA Medical Center	Milwaukee	Wisconsin
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Hartford Hospital	New Britain	Connecticut
United States	Yale University	New Haven	Connecticut
United States	Sentara Vascular Specialists	Norfolk	Virginia
United States	Kansas City Vascular	North Kansas City	Missouri
United States	Vascular Institute of Central Florida	Orlando	Florida
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Banner Good Samaritan Hospital	Phoenix	Arizona
United States	Sacramento Vascular Sugeons	Sacramento	California
United States	Saint Louis University	Saint Louis	Missouri
United States	Peninsula Regional Medical Center	Salisbury	Maryland
United States	Kaiser - Santa Clara	Santa Clara	California
United States	Sarasota Vascular Specialists	Sarasota	Florida
United States	North Central Heart	Sioux Falls	South Dakota
United States	Prairie Education & Research Cooperative	Springfield	Illinois
United States	Peachtree Vascular Specialists	Stockbridge	Georgia
United States	USF/Tampa VA	Tampa	Florida
United States	Carondelet Heart and Vascular Institute	Tucson	Arizona
United States	North MS Medical Center	Tupelo	Mississippi
United States	Peacehealth Southwest Medical Center	Vancouver	Washington
United States	The Iowa Clinic Cardiovascular Services	West Des Moines	Iowa
United States	Neo Vascular (Lake West)	Willoughby	Ohio
United States	Cadence Physician Group	Winfield	Illinois
United States	Wake Forest	Winston-Salem	North Carolina
United States	St. Joseph Mercy Ann Arbor	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Endologix

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Russian. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The Number of MAEs	Major Adverse Events	At 30 days, 12 months, and annually up to five years
Secondary	The Number of Aneurysm Related Complications (ARC)	ARC is a composite outcome	Post 12 Months up to Five Years
Secondary	The Number of Participants With Aneurysm Related Mortality	Death related to the aneurysm	Up to Five Years
Secondary	Number of Endoleaks Classified by Type	All Endoloeaks	Up to Five Years
Secondary	Loss of Neck Apposition as Measured by Length in mm	Loss of Neck Apposition as measured by length in mm	Up to Five Years
Secondary	Number of AAA Related Secondary Procedures	Number of AAA related secondary procedures	Up to Five Years
Secondary	Number of Device Integrity Events	Number of device integrity events from device fractures and technical observations related to the stent graft	Up to Five Years
Secondary	Number of Adjunctive Procedures Necessitated During the Implant Procedure.	Number of adjunctive procedures done during the implant procedure	Up to Five Years