Fenestrated AAA Endovascular Graft Post-Approval Study

• Sponsor: Cook Research Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01990950
• Collaborator: (none)
• Enrollment: 21
• Locations: 6
• Arm: 1
• Duration (Months): 79.4
• Patients Per Site: 3.5
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This post-market study is approved by the US FDA to evaluate the long-term safety and performance of the Zenith® Fenestrated AAA Endovascular Graft.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Long-term Safety and Performance of the Zenith® Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Post-Approval Study
• Study Start Date: Mar 1, 2014
• Actual Primary Completion Date: Oct 12, 2020
• Actual Study Completion Date: Oct 12, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Zenith® Fenestrated AAA Endovascular Graft	Device: Zenith® Fenestrated AAA Endovascular Graft; 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 aneursyms having morphology suitable for endovascular repair

Outcome Measures

Primary Outcome Measures

1. Treatment Success : AAA Related Mortality [5 years]

   patients treated with the Zenith® Fenestrated AAA Endovascular Graft will have a rate of aneurysm-related mortality at 5 years that meets a performance goal of 18% ,

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 aneursyms with a diameter greater than or equal to 5 cm

• aortic or aortoiliac aneurysm with a history of growth greater than or equal to 0.5 cm per year, or clinical indication for AAA repair

Exclusion Criteria:

• proximal neck less than 4mm 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-Davis	Sacramento	California	United States	95817
2	University of Colorado	Aurora	Colorado	United States	80045
3	Borgess Research Institute	Kalamazoo	Michigan	United States	49048
4	Newark Beth Israel Medical Center	Newark	New Jersey	United States	07112
5	Wake Forest University Health	Winston-Salem	North Carolina	United States	27102
6	University of Wisconsin Hospital and Clinics	Madison	Wisconsin	United States	53711

Sponsors and Collaborators

• Cook Research Incorporated

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Apr 5, 2018

More Information

Publications

None provided.

• Responsible Party: Cook Research Incorporated
• ClinicalTrials.gov Identifier: NCT01990950
• Other Study ID Numbers: 11-005
• First Posted: Nov 25, 2013
• Last Update Posted: Oct 5, 2021
• Last Verified: Sep 1, 2021

• Keywords provided by Cook Research Incorporated: Aneurysm; Aortic Aneurysm; Iliac Aneurysm; Aortic Aneurysm, Abdominal; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases
• 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	Zenith® Fenestrated AAA Endovascular Graft: 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 aneursyms having morphology suitable for endovascular repair
Period Title: Overall Study
STARTED	21
COMPLETED	10
NOT COMPLETED	11

Baseline Characteristics

Arm/Group Title	Zenith® Fenestrated AAA Endovascular Graft
Arm/Group Description	The Zenith® Fenestrated AAA Endovascular Graft is a modular system consisting of three components, a proximal body graft, a distal bifurcated body graft and one iliac leg. Additional ancillary components (main body extensions, iliac leg extensions, converters, and occluders) are available. The Zenith® Alignment Stent is a balloon-expandable stent that can be deployed through scallops or fenestrations in a Zenith® Fenestrated AAA Endovascular Graft into branch vessels of the aorta.
Overall Participants	21
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	5 23.8%
>=65 years	16 76.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	70.1 (6.9)
Sex: Female, Male (Count of Participants)
Female	6 28.6%
Male	15 71.4%
Race/Ethnicity, Customized (Count of Participants)
Asian	1 4.8%
White	19 90.5%
White; Hispanic or Latino	1 4.8%
Region of Enrollment (Count of Participants)
United States	21 100%

Outcome Measures

1. Primary Outcome

Title	Treatment Success : AAA Related Mortality
Description	patients treated with the Zenith® Fenestrated AAA Endovascular Graft will have a rate of aneurysm-related mortality at 5 years that meets a performance goal of 18% ,
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair

Arm/Group Title	Zenith® Fenestrated AAA Endovascular Graft
Arm/Group Description	The Zenith® Fenestrated AAA Endovascular Graft is a modular system consisting of three components, a proximal body graft, a distal bifurcated body graft and one iliac leg. Additional ancillary components (main body extensions, iliac leg extensions, converters, and occluders) are available. The Zenith® Alignment Stent is a balloon-expandable stent that can be deployed through scallops or fenestrations in a Zenith® Fenestrated AAA Endovascular Graft into branch vessels of the aorta
Measure Participants	21
Count of Participants [Participants]	0 0%

Adverse Events

Time Frame	5 years
Arm/Group Title	Zenith® Fenestrated AAA Endovascular Graft
Arm/Group Description	The Zenith® Fenestrated AAA Endovascular Graft is a modular system consisting of three components, a proximal body graft, a distal bifurcated body graft and one iliac leg.
All Cause Mortality
	Zenith® Fenestrated AAA Endovascular Graft
	Affected / at Risk (%)	# Events
Total	3/21 (14.3%)
Serious Adverse Events
	Zenith® Fenestrated AAA Endovascular Graft
	Affected / at Risk (%)	# Events
Total	11/21 (52.4%)
Cardiac disorders
Arrhythmia	1/21 (4.8%)	1
Atrial fibrillation	2/21 (9.5%)	4
Atrial flutter	1/21 (4.8%)	2
Atrioventricular block second degree	1/21 (4.8%)	1
Cardiac failure congestive	1/21 (4.8%)	1
Myocardial infarction	1/21 (4.8%)	1
Myocardial ischaemia	3/21 (14.3%)	3
Gastrointestinal disorders
Pancreatitis acute	1/21 (4.8%)	1
Retroperitoneal haematoma	1/21 (4.8%)	1
General disorders
Stent-graft endoleak	2/21 (9.5%)	3
Hepatobiliary disorders
Bile duct stone	1/21 (4.8%)	1
Gallbladder mass	1/21 (4.8%)	1
Infections and infestations
Biliary tract infection	1/21 (4.8%)	1
Sepsis	1/21 (4.8%)	1
Injury, poisoning and procedural complications
Acetabulum fracture	1/21 (4.8%)	1
Fall	1/21 (4.8%)	1
Humerus fracture	1/21 (4.8%)	1
Injury	1/21 (4.8%)	1
Vascular access site pseudoaneurysm	1/21 (4.8%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma	1/21 (4.8%)	1
Nervous system disorders
Intracranial aneurysm	1/21 (4.8%)	1
Renal and urinary disorders
Acute kidney injury	1/21 (4.8%)	1
Renal tubular necrosis	1/21 (4.8%)	1
Surgical and medical procedures
Dialysis	1/21 (4.8%)	1
Transfusion	1/21 (4.8%)	1
Vascular disorders
Aortic aneurysm	1/21 (4.8%)	1
Aortic aneurysm rupture	1/21 (4.8%)	1
Aortic dissection	1/21 (4.8%)	1
Peripheral artery aneurysm	1/21 (4.8%)	1
Other (Not Including Serious) Adverse Events
	Zenith® Fenestrated AAA Endovascular Graft
	Affected / at Risk (%)	# Events
Total	13/21 (61.9%)
Cardiac disorders
Atrial fibrillation	2/21 (9.5%)	5
Cardiac failure congestive	2/21 (9.5%)	2
Myocardial ischaemia	3/21 (14.3%)	3
Gastrointestinal disorders
Constipation	2/21 (9.5%)	4
General disorders
Stent-graft endoleak	2/21 (9.5%)	3
Infections and infestations
Pneumonia	2/21 (9.5%)	2
Renal and urinary disorders
Renal infarct	3/21 (14.3%)	3
Surgical and medical procedures
Transfusion	2/21 (9.5%)	2
Vascular disorders
Aortic aneurysm	3/21 (14.3%)	3

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.