PRESERVE-Zenith® Branch Endovascular Graft-Iliac Bifurcation Clinical Study

Sponsor

Cook Research Incorporated (Industry)

Overall Status

Completed

CT.gov ID

NCT02571907

Collaborator

(none)

Enrollment

Locations

Arm

79.1

Actual Duration (Months)

1.4

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Aortoiliac Aneurysms Iliac Aneurysms	Device: Zenith® Branch Endovascular Graft-Iliac Bifurcation, Device: Atrium iCAST™ Device: Zenith® Flex AAA Endovascular Graft	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2014

Actual Primary Completion Date :

Nov 1, 2015

Actual Study Completion Date :

Nov 4, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Zenith® Branch Endovascular Graft-Iliac Bifurcation Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Atrium iCAST™ and the Zenith® Flex AAA Endovascular Graft	Device: Zenith® Branch Endovascular Graft-Iliac Bifurcation, Implantation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation. Other Names: Branch Graft Device: Atrium iCAST™ Implantation of Atrium iCAST Device: Zenith® Flex AAA Endovascular Graft Implantation of the Zenith Flex Endovascular Graft

Arm

Intervention/Treatment

Experimental: Zenith® Branch Endovascular Graft-Iliac Bifurcation

Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Atrium iCAST™ and the Zenith® Flex AAA Endovascular Graft

Device: Zenith® Branch Endovascular Graft-Iliac Bifurcation,

Implantation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation.

Other Names:

Branch Graft

Device: Atrium iCAST™

Implantation of Atrium iCAST

Device: Zenith® Flex AAA Endovascular Graft

Implantation of the Zenith Flex Endovascular Graft

Outcome Measures

Primary Outcome Measures

Number of patients with freedom from patency-related intervention defined as a secondary intervention to treat a > 60 % stenosis of the internal iliac artery associated with clinical symptoms. [6 months]

Secondary Outcome Measures

Freedom from morbidity (i.e., morbidity index) [30 days]
Morbidity index based on a composite endpoint of 31 pre-specified measure elements in seven categories (i.e., cardiovascular, pulmonary, renal, bowel, wound, neurologic, and vascular).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

An aortioiliac or iliac aneurysm
An unsuitable distal sealing site for a traditional Zenith iliac leg graft within the common lilac 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
Pregnant, breast-feeding or planning on becoming pregnant prior to completion of the study
Unwilling or unable to comply with the follow-up schedule
Simultaneously participating in another investigative device or drug study

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 School	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 Hospital	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	University of Nebraska	Omaha	Nebraska	United States	68105
17	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
18	Columbia University Medical Center	New York	New York	United States	10032
19	Weill Cornell Medical Center	New York	New York	United States	10065
20	University of North Carolina	Chapel Hill	North Carolina	United States	27599
21	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
22	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
23	Allegheny General Hospital	Pittsburgh	Pennsylvania	United States	15212
24	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
25	Medical University of South Carolina	Charleston	South Carolina	United States	29425
26	UT Southwestern	Dallas	Texas	United States	75235
27	University of Virginia	Charlottesville	Virginia	United States	22908
28	Aurora St. Luke's Hospital	Milwaukee	Wisconsin	United States	53215