Trial Outcomes & Findings for Fenestrated AAA Endovascular Graft Post-Approval Study (NCT NCT01990950)

NCT ID: NCT01990950

Last Updated: 2021-10-05

Results Overview

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% ,

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 21 participants
• Primary outcome timeframe: 5 years
• Results posted on: 2021-10-05

Participant Flow

Participant milestones

Measure	Zenith® Fenestrated AAA Endovascular Graft 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
Overall Study STARTED	21
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Measure	Zenith® Fenestrated AAA Endovascular Graft 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
Overall Study Death	3
Overall Study Lost to Follow-up	2
Overall Study Withdrawal by Subject	6

Baseline Characteristics

Fenestrated AAA Endovascular Graft Post-Approval Study

Baseline characteristics by cohort

Measure	Zenith® Fenestrated AAA Endovascular Graft n=21 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	16 Participants n=5 Participants
Age, Continuous	70.1 years STANDARD_DEVIATION 6.9 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized White	19 Participants n=5 Participants
Race/Ethnicity, Customized White; Hispanic or Latino	1 Participants n=5 Participants
Region of Enrollment United States	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 years

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

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% ,

Outcome measures

Measure

Zenith® Fenestrated AAA Endovascular Graft n=21 Participants 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

Treatment Success : AAA Related Mortality

0 Participants

Adverse Events

Zenith® Fenestrated AAA Endovascular Graft

Serious events: 11 serious events

Other events: 13 other events

Deaths: 3 deaths

Serious adverse events

Measure	Zenith® Fenestrated AAA Endovascular Graft n=21 participants at risk 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.
Cardiac disorders Arrhythmia	4.8% 1/21 • Number of events 1 • 5 years
Cardiac disorders Atrial fibrillation	9.5% 2/21 • Number of events 4 • 5 years
Cardiac disorders Atrial flutter	4.8% 1/21 • Number of events 2 • 5 years
Cardiac disorders Atrioventricular block second degree	4.8% 1/21 • Number of events 1 • 5 years
Cardiac disorders Cardiac failure congestive	4.8% 1/21 • Number of events 1 • 5 years
Cardiac disorders Myocardial infarction	4.8% 1/21 • Number of events 1 • 5 years
Cardiac disorders Myocardial ischaemia	14.3% 3/21 • Number of events 3 • 5 years
Gastrointestinal disorders Pancreatitis acute	4.8% 1/21 • Number of events 1 • 5 years
Gastrointestinal disorders Retroperitoneal haematoma	4.8% 1/21 • Number of events 1 • 5 years
General disorders Stent-graft endoleak	9.5% 2/21 • Number of events 3 • 5 years
Hepatobiliary disorders Bile duct stone	4.8% 1/21 • Number of events 1 • 5 years
Hepatobiliary disorders Gallbladder mass	4.8% 1/21 • Number of events 1 • 5 years
Infections and infestations Biliary tract infection	4.8% 1/21 • Number of events 1 • 5 years
Infections and infestations Sepsis	4.8% 1/21 • Number of events 1 • 5 years
Injury, poisoning and procedural complications Acetabulum fracture	4.8% 1/21 • Number of events 1 • 5 years
Injury, poisoning and procedural complications Fall	4.8% 1/21 • Number of events 1 • 5 years
Injury, poisoning and procedural complications Humerus fracture	4.8% 1/21 • Number of events 1 • 5 years
Injury, poisoning and procedural complications Injury	4.8% 1/21 • Number of events 1 • 5 years
Injury, poisoning and procedural complications Vascular access site pseudoaneurysm	4.8% 1/21 • Number of events 1 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	4.8% 1/21 • Number of events 1 • 5 years
Nervous system disorders Intracranial aneurysm	4.8% 1/21 • Number of events 1 • 5 years
Renal and urinary disorders Acute kidney injury	4.8% 1/21 • Number of events 1 • 5 years
Renal and urinary disorders Renal tubular necrosis	4.8% 1/21 • Number of events 1 • 5 years
Surgical and medical procedures Dialysis	4.8% 1/21 • Number of events 1 • 5 years
Surgical and medical procedures Transfusion	4.8% 1/21 • Number of events 1 • 5 years
Vascular disorders Aortic aneurysm	4.8% 1/21 • Number of events 1 • 5 years
Vascular disorders Aortic aneurysm rupture	4.8% 1/21 • Number of events 1 • 5 years
Vascular disorders Aortic dissection	4.8% 1/21 • Number of events 1 • 5 years
Vascular disorders Peripheral artery aneurysm	4.8% 1/21 • Number of events 1 • 5 years

Other adverse events

Measure	Zenith® Fenestrated AAA Endovascular Graft n=21 participants at risk 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.
Cardiac disorders Atrial fibrillation	9.5% 2/21 • Number of events 5 • 5 years
Cardiac disorders Cardiac failure congestive	9.5% 2/21 • Number of events 2 • 5 years
Gastrointestinal disorders Constipation	9.5% 2/21 • Number of events 4 • 5 years
General disorders Stent-graft endoleak	9.5% 2/21 • Number of events 3 • 5 years
Infections and infestations Pneumonia	9.5% 2/21 • Number of events 2 • 5 years
Surgical and medical procedures Transfusion	9.5% 2/21 • Number of events 2 • 5 years
Vascular disorders Aortic aneurysm	14.3% 3/21 • Number of events 3 • 5 years
Renal and urinary disorders Renal infarct	14.3% 3/21 • Number of events 3 • 5 years
Cardiac disorders Myocardial ischaemia	14.3% 3/21 • Number of events 3 • 5 years

Additional Information

Alan Saunders, MS, RAC; Manager, Biostatistics

Cook Research Incorporated

Phone: 765-463-7537

Email: alan.saunders@cookmedical.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60