Zenith(R) Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Clinical Study

• Sponsor: Cook Group Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00875563
• Collaborator: (none)
• Enrollment: 42
• Locations: 14
• Arm: 1
• Duration (Months): 128
• Patients Per Site: 3
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The Zenith(R) Fenestrated AAA Endovascular Graft Clinical Study is a clinical investigation approved by the US FDA to study the safety and effectiveness of the Zenith(R) Fenestrated AAA Endovascular Graft in the treatment of abdominal aortic and aorto-iliac aneurysms.

Condition or Disease	Intervention/Treatment	Phase
Abdominal Aortic Aneurysms; Aorto-iliac Aneurysms; Juxtarenal Aneurysms	Device: Zenith(R) Fenestrated AAA Endovascular Graft	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Safety and Effectiveness of the Zenith(R) Fenestrated AAA Endovascular Graft
• Study Start Date: Jan 1, 2005
• Actual Primary Completion Date: Feb 1, 2011
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Zenith(R) Fenestrated AAA Endovascular Graft	Device: Zenith(R) Fenestrated AAA Endovascular Graft; The Zenith(R) Fenestrated AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Treatment Success [6 months]

   Technical success (successful access, deployment, and patency of the Fenestrated Graft, and patency of all vessels targeted by a fenestration intra-operatively), and freedom from the following: type I or type III endoleaks, AAA-related serious adverse events, AAA-related major complications, and aneurysm enlargement greater than 0.5 cm. A serious adverse event is defined as any occurrence of death, aneurysm rupture, or conversion to open surgical repair. A major complication is defined as any occurrence of Q-wave myocardial infarction, congestive heart failure, cardiac ischemia requiring intervention, renal failure requiring permanent dialysis, bowel obstruction, ischemia, or fistula, stroke with permanent deficit, or paralysis.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Abdominal aortic and aortoiliac aneurysms with diameter greater than or equal to 5 cm

Exclusion Criteria:

• Proximal neck less than 4 mm or greater than or equal to 15 mm in length unless otherwise compromised to preclude seal

• Renal artery stenosis greater than 50 percent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Francisco	San Francisco	California	United States	94143
2	Shands Hospital	Gainesville	Florida	United States	32610
3	The Indiana Heart Hospital	Indianapolis	Indiana	United States	46250
4	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
5	University of Massachusetts	Worcester	Massachusetts	United States	01655
6	Mayo Clinic	Rochester	Minnesota	United States	55905
7	Barnes-Jewish Hospital	St. Louis	Missouri	United States	63110
8	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
9	NYU Medical Center	New York	New York	United States	10016
10	University of North Carolina	Chapel Hill	North Carolina	United States	27599
11	Cleveland Clinic	Cleveland	Ohio	United States	44195
12	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
13	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
14	Harborview Medical Center	Seattle	Washington	United States	98104

Sponsors and Collaborators

• Cook Group Incorporated

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Zenith abdominal aortic aneurysm endovascular graft

Publications

None provided.

• Responsible Party: Cook Group Incorporated
• ClinicalTrials.gov Identifier: NCT00875563
• Other Study ID Numbers: 04-541; 370015, FNCT
• First Posted: Apr 3, 2009
• Last Update Posted: Jan 11, 2017
• Last Verified: Mar 1, 2016

• Additional relevant MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Iliac Aneurysm

Study Results

Participant Flow

Arm/Group Title	Zenith® Fenestrated AAA Endovascular Graft
Arm/Group Description	The Zenith® Fenestrated AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair
Period Title: Overall Study
STARTED	42
COMPLETED	18
NOT COMPLETED	24

Baseline Characteristics

Arm/Group Title	Zenith® Fenestrated AAA Endovascular Graft
Arm/Group Description	The Zenith® Fenestrated AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair
Overall Participants	42
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	75.3 (7.4)
Gender (Count of Participants)
Female	9 21.4%
Male	33 78.6%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Treatment Success
Description	Technical success (successful access, deployment, and patency of the Fenestrated Graft, and patency of all vessels targeted by a fenestration intra-operatively), and freedom from the following: type I or type III endoleaks, AAA-related serious adverse events, AAA-related major complications, and aneurysm enlargement greater than 0.5 cm. A serious adverse event is defined as any occurrence of death, aneurysm rupture, or conversion to open surgical repair. A major complication is defined as any occurrence of Q-wave myocardial infarction, congestive heart failure, cardiac ischemia requiring intervention, renal failure requiring permanent dialysis, bowel obstruction, ischemia, or fistula, stroke with permanent deficit, or paralysis.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Two patients were lost to follow-up and did not have CT data at 6 months. Patients treated with the Zenith® Fenestrated AAA Endovascular Graft was compared to propensity score matched patients treated with the Zenith® AAA Endovascular Graft (NCT00196092, link to 5-year study results provided).

Arm/Group Title	Zenith® Fenestrated AAA Endovascular Graft
Arm/Group Description
Measure Participants	40
Number [participants]	39 92.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Zenith® Fenestrated AAA Endovascular Graft
	Comments	Patients treated with the Zenith® Fenestrated AAA Endovascular Graft were compared with matched patients treated with the Zenith® AAA Endovascular Graft.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	An exact test method (Sidik K. 2003, Statistics in Medicine 22: 265-278) for matched controls was used, at a type I error rate of 0.05 and a non-inferiority margin of 10%. 38 pairs of patients were determined necessary, and the power was calculated to be 0.92.
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	Exact test for matched pairs
	Comments

Adverse Events

Time Frame	5 years
Arm/Group Title	Zenith® Fenestrated AAA Endovascular Graft
Arm/Group Description	The Zenith® Fenestrated AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair
All Cause Mortality
	Zenith® Fenestrated AAA Endovascular Graft
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Zenith® Fenestrated AAA Endovascular Graft
	Affected / at Risk (%)	# Events
Total	4/42 (9.5%)
General disorders
Death	4/42 (9.5%)	4
Other (Not Including Serious) Adverse Events
	Zenith® Fenestrated AAA Endovascular Graft
	Affected / at Risk (%)	# Events
Total	24/42 (57.1%)
Cardiac disorders
Arrhythmia requiring intervention or new treatment	6/42 (14.3%)	6
Congestive heart failure	4/42 (9.5%)	4
Renal and urinary disorders
Creatinine rise > 2 mg/dl and > 30% from baseline on two or more follow-up tests	5/42 (11.9%)	5
Occlusion of a fenestrated renal vessel	3/42 (7.1%)	3
Renal infarct	5/42 (11.9%)	5
Respiratory, thoracic and mediastinal disorders
Pneumonia requiring antibiotics	6/42 (14.3%)	8
Vascular disorders
Post-procedure transfusion	9/42 (21.4%)	10

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.