Trial Outcomes & Findings for Zenith(R) Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Clinical Study (NCT NCT00875563)

NCT ID: NCT00875563

Last Updated: 2017-01-11

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 42 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2017-01-11

Participant Flow

Participant milestones

Measure	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 aneurysms having morphology suitable for endovascular repair
Overall Study STARTED	42
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	24

Reasons for withdrawal

Measure	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 aneurysms having morphology suitable for endovascular repair
Overall Study Death	4
Overall Study Withdrawal by Subject	7
Overall Study No long-term (3-5 year) consent	6
Overall Study Still be eligible for follow-up	7

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Zenith® Fenestrated AAA Endovascular Graft n=42 Participants 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
Age, Continuous	75.3 years STANDARD_DEVIATION 7.4 • n=5 Participants
Gender Female	9 Participants n=5 Participants
Gender Male	33 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 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).

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.

Outcome measures

Measure	Zenith® Fenestrated AAA Endovascular Graft n=40 Participants
Number of Participants With Treatment Success	39 participants

Adverse Events

Zenith® Fenestrated AAA Endovascular Graft

Serious events: 4 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Measure	Zenith® Fenestrated AAA Endovascular Graft n=42 participants at risk 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
General disorders Death	9.5% 4/42 • Number of events 4 • 5 years

Other adverse events

Measure	Zenith® Fenestrated AAA Endovascular Graft n=42 participants at risk 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
Cardiac disorders Arrhythmia requiring intervention or new treatment	14.3% 6/42 • Number of events 6 • 5 years
Cardiac disorders Congestive heart failure	9.5% 4/42 • Number of events 4 • 5 years
Respiratory, thoracic and mediastinal disorders Pneumonia requiring antibiotics	14.3% 6/42 • Number of events 8 • 5 years
Renal and urinary disorders Creatinine rise > 2 mg/dl and > 30% from baseline on two or more follow-up tests	11.9% 5/42 • Number of events 5 • 5 years
Renal and urinary disorders Occlusion of a fenestrated renal vessel	7.1% 3/42 • Number of events 3 • 5 years
Renal and urinary disorders Renal infarct	11.9% 5/42 • Number of events 5 • 5 years
Vascular disorders Post-procedure transfusion	21.4% 9/42 • Number of events 10 • 5 years

Additional Information

Scott Snyder, PhD, Director of Clinical Science & Biostatistics

Cook Research Incorporated

Phone: 765-463-7537

Email: SSnyder@medinst.com

Results disclosure agreements

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

Restriction type: GT60