PRESERVE-Zenith® Branch Endovascular Graft-Iliac Bifurcation

Sponsor

Cook Research Incorporated (Industry)

Overall Status

No longer available

CT.gov ID

NCT02475798

Collaborator

(none)

Locations

Study Details

Study Description

Brief Summary

The purpose of this extended study is to collect confirmatory safety and effectiveness data on the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the commercially available Atrium iCAST™ covered stent in the treatment of aortoiliac and iliac aneurysms.

Condition or Disease	Intervention/Treatment	Phase
Aortoiliac Aneurysms Iliac Aneurysms	Device: Zenith® Branch Endovascular Graft-Iliac Bifurcation,

Study Design

Study Type:

Expanded Access

Official Title:

Clinical Study to Collect Confirmatory Safety and Effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

An aortoiliac or iliac aneurysm of appropriate size
Unsuitable distal sealing site for a traditional Zenith® iliac leg graft within the common iliac artery

Exclusion Criteria:

Less than 18 years of age
Inability or refusal to give informed consent
Disease considerations that would compromise patient safety or study outcomes
Unsuitable arterial anatomy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Foundation for Medical Education and Research	Phoenix	Arizona	United States	85054
2	VA Palo Alto HCS	Palo Alto	California	United States	94304
3	Stanford University Medical Center	Stanford	California	United States	94305
4	Christine E. Lynn Heart and Vascular Institute	Boca Raton	Florida	United States	33431
5	South Florida Medical Imaging	Fort Lauderdale	Florida	United States	33308
6	University of Florida	Gainesville	Florida	United States	32610
7	Emory University	Atlanta	Georgia	United States	30322
8	St. Anthony's Medical Center	Rockford	Illinois	United States	61108
9	Methodist Hospital of Indiana	Indianapolis	Indiana	United States	46202
10	University of Kentucky Hospital	Lexington	Kentucky	United States	40536
11	University of Massachusetts	Worcester	Massachusetts	United States	01655
12	William Beaumont Hospital	Royal Oak	Michigan	United States	48073
13	Mayo Clinic	Rochester	Minnesota	United States	55905
14	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
15	Mercy Hospital East Communities	Saint Louis	Missouri	United States	63141
16	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
17	Columbia University Medical Center	New York	New York	United States	10032
18	Weill Cornell Medical Center	New York	New York	United States	10065
19	University of North Carolina	Chapel Hill	North Carolina	United States	27599
20	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
21	Allegheny General Hospital	Pittsburgh	Pennsylvania	United States	15212
22	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
23	Medical University of South Carolina	Charleston	South Carolina	United States	29425
24	UT Southwestern	Dallas	Texas	United States	75235
25	University of Virginia	Charlottesville	Virginia	United States	22908
26	Aurora St. Luke's Hospital	Milwaukee	Wisconsin	United States	53215