Trial Outcomes & Findings for Zenith® Low Profile AAA Endovascular Graft (NCT NCT02535065)
NCT ID: NCT02535065
Last Updated: 2022-04-19
Results Overview
Major adverse events include all-cause death, Q-wave MI, renal failure requiring dialysis, paralysis, stroke, bowel ischemia, re-intubation
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
62 participants
Primary outcome timeframe
30 days
Results posted on
2022-04-19
Participant Flow
Participant milestones
| Measure |
Endovascular Graft
The Zenith Low Profile AAA Endovascular Graft and ancillary components
Zenith Low Profile AAA Endovascular Graft and ancillary components: Treatment of patients with abdominal aortic, aortoiliac, or iliac aneurysms having morphology suitable for endovascular repair
|
|---|---|
|
Overall Study
STARTED
|
62
|
|
Overall Study
1-Month Follow-up
|
62
|
|
Overall Study
12-Month Follow-up
|
61
|
|
Overall Study
COMPLETED
|
42
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
| Measure |
Endovascular Graft
The Zenith Low Profile AAA Endovascular Graft and ancillary components
Zenith Low Profile AAA Endovascular Graft and ancillary components: Treatment of patients with abdominal aortic, aortoiliac, or iliac aneurysms having morphology suitable for endovascular repair
|
|---|---|
|
Overall Study
Death
|
13
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
Baseline Characteristics
Zenith® Low Profile AAA Endovascular Graft
Baseline characteristics by cohort
| Measure |
Endovascular Graft
n=62 Participants
The Zenith Low Profile AAA Endovascular Graft and ancillary components
Zenith Low Profile AAA Endovascular Graft and ancillary components: Treatment of patients with abdominal aortic, aortoiliac, or iliac aneurysms having morphology suitable for endovascular repair
|
|---|---|
|
Age, Continuous
|
70.5 years
STANDARD_DEVIATION 8.9 • n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
61 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
62 Participants
n=99 Participants
|
|
Diabetes
Yes
|
15 Participants
n=99 Participants
|
|
Diabetes
No
|
47 Participants
n=99 Participants
|
|
Smoking Status
Current
|
16 Participants
n=99 Participants
|
|
Smoking Status
Past
|
40 Participants
n=99 Participants
|
|
Smoking Status
Never
|
6 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 30 daysMajor adverse events include all-cause death, Q-wave MI, renal failure requiring dialysis, paralysis, stroke, bowel ischemia, re-intubation
Outcome measures
| Measure |
Endovascular Graft
n=62 Participants
The Zenith Low Profile AAA Endovascular Graft and ancillary components
Zenith Low Profile AAA Endovascular Graft and ancillary components: Treatment of patients with abdominal aortic, aortoiliac, or iliac aneurysms having morphology suitable for endovascular repair
|
|---|---|
|
Number of Patients Without Major Adverse Events Within 30 Days
|
62 Participants
|
PRIMARY outcome
Timeframe: 12 monthsDevice success will be measured with none of the following: type I or III endoleaks requiring re-intervention, graft limb occlusion, aneurysm rupture or conversion to open surgical repair, aneurysm enlargement greater than 0.5 cm
Outcome measures
| Measure |
Endovascular Graft
n=62 Participants
The Zenith Low Profile AAA Endovascular Graft and ancillary components
Zenith Low Profile AAA Endovascular Graft and ancillary components: Treatment of patients with abdominal aortic, aortoiliac, or iliac aneurysms having morphology suitable for endovascular repair
|
|---|---|
|
Number of Patients With Device Success
|
57 Participants
|
Adverse Events
Endovascular Graft
Serious events: 49 serious events
Other events: 7 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Endovascular Graft
n=62 participants at risk
The Zenith Low Profile AAA Endovascular Graft and ancillary components
Zenith Low Profile AAA Endovascular Graft and ancillary components: Treatment of patients with abdominal aortic, aortoiliac, or iliac aneurysms having morphology suitable for endovascular repair
|
|---|---|
|
Cardiac disorders
Angina unstable
|
1.6%
1/62 • Number of events 1 • 5 years
|
|
Cardiac disorders
Arrhythmia
|
9.7%
6/62 • Number of events 11 • 5 years
|
|
Cardiac disorders
Bradycardia
|
1.6%
1/62 • Number of events 1 • 5 years
|
|
Cardiac disorders
Cardiac arrest
|
3.2%
2/62 • Number of events 2 • 5 years
|
|
Cardiac disorders
Cardiac failure congestive
|
4.8%
3/62 • Number of events 4 • 5 years
|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.6%
1/62 • Number of events 1 • 5 years
|
|
Cardiac disorders
Myocardial infarction
|
4.8%
3/62 • Number of events 5 • 5 years
|
|
Cardiac disorders
Myocardial ischaemia
|
8.1%
5/62 • Number of events 5 • 5 years
|
|
Ear and labyrinth disorders
Vertigo
|
1.6%
1/62 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Gastritis
|
1.6%
1/62 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
3.2%
2/62 • Number of events 3 • 5 years
|
|
Gastrointestinal disorders
Ileus
|
1.6%
1/62 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Intestinal obstruction
|
3.2%
2/62 • Number of events 2 • 5 years
|
|
General disorders
Chest pain
|
3.2%
2/62 • Number of events 2 • 5 years
|
|
General disorders
Stent-graft endoleak
|
8.1%
5/62 • Number of events 5 • 5 years
|
|
General disorders
Vascular stent occlusion
|
8.1%
5/62 • Number of events 6 • 5 years
|
|
General disorders
Vascular stent stenosis
|
3.2%
2/62 • Number of events 2 • 5 years
|
|
General disorders
Vascular stent thrombosis
|
1.6%
1/62 • Number of events 1 • 5 years
|
|
General disorders
Vessel puncture site haematoma
|
1.6%
1/62 • Number of events 1 • 5 years
|
|
Hepatobiliary disorders
Cholecystitis
|
3.2%
2/62 • Number of events 2 • 5 years
|
|
Immune system disorders
Contrast media reaction
|
1.6%
1/62 • Number of events 1 • 5 years
|
|
Infections and infestations
Bursitis infective
|
1.6%
1/62 • Number of events 1 • 5 years
|
|
Infections and infestations
Diverticulitis
|
1.6%
1/62 • Number of events 1 • 5 years
|
|
Infections and infestations
Gastrointestinal infection
|
1.6%
1/62 • Number of events 1 • 5 years
|
|
Infections and infestations
Influenza
|
1.6%
1/62 • Number of events 1 • 5 years
|
|
Infections and infestations
Pneumonia
|
14.5%
9/62 • Number of events 10 • 5 years
|
|
Infections and infestations
Sepsis
|
3.2%
2/62 • Number of events 2 • 5 years
|
|
Infections and infestations
Urinary tract infection
|
3.2%
2/62 • Number of events 2 • 5 years
|
|
Injury, poisoning and procedural complications
Endotracheal intubation complication
|
1.6%
1/62 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Fall
|
1.6%
1/62 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
1.6%
1/62 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
1.6%
1/62 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
1.6%
1/62 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
1.6%
1/62 • Number of events 1 • 5 years
|
|
Investigations
Blood glucose increased
|
1.6%
1/62 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.2%
2/62 • Number of events 2 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
4.8%
3/62 • Number of events 4 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
1.6%
1/62 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal cancer metastatic
|
1.6%
1/62 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
1.6%
1/62 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
1.6%
1/62 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
1.6%
1/62 • Number of events 1 • 5 years
|
|
Nervous system disorders
Cerebral small vessel ischaemic disease
|
1.6%
1/62 • Number of events 1 • 5 years
|
|
Nervous system disorders
Cerebrovascular accident
|
3.2%
2/62 • Number of events 2 • 5 years
|
|
Nervous system disorders
Haemorrhagic cerebellar infarction
|
1.6%
1/62 • Number of events 1 • 5 years
|
|
Nervous system disorders
Metabolic encephalopathy
|
1.6%
1/62 • Number of events 1 • 5 years
|
|
Nervous system disorders
Seizure
|
3.2%
2/62 • Number of events 2 • 5 years
|
|
Nervous system disorders
Syncope
|
1.6%
1/62 • Number of events 1 • 5 years
|
|
Nervous system disorders
Transient ischaemic attack
|
1.6%
1/62 • Number of events 1 • 5 years
|
|
Product Issues
Device kink
|
3.2%
2/62 • Number of events 2 • 5 years
|
|
Psychiatric disorders
Anxiety
|
1.6%
1/62 • Number of events 1 • 5 years
|
|
Psychiatric disorders
Depression
|
1.6%
1/62 • Number of events 1 • 5 years
|
|
Psychiatric disorders
Mental status changes
|
1.6%
1/62 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Acute kidney injury
|
3.2%
2/62 • Number of events 2 • 5 years
|
|
Renal and urinary disorders
Haematuria
|
1.6%
1/62 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Urinary retention
|
1.6%
1/62 • Number of events 1 • 5 years
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
1.6%
1/62 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
3.2%
2/62 • Number of events 3 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
11.3%
7/62 • Number of events 7 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
1.6%
1/62 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.2%
2/62 • Number of events 2 • 5 years
|
|
Surgical and medical procedures
Hip arthroplasty
|
1.6%
1/62 • Number of events 2 • 5 years
|
|
Surgical and medical procedures
Ileostomy closure
|
1.6%
1/62 • Number of events 1 • 5 years
|
|
Surgical and medical procedures
Knee arthroplasty
|
1.6%
1/62 • Number of events 1 • 5 years
|
|
Surgical and medical procedures
Mechanical ventilation
|
3.2%
2/62 • Number of events 2 • 5 years
|
|
Vascular disorders
Aortic aneurysm
|
1.6%
1/62 • Number of events 1 • 5 years
|
|
Vascular disorders
Hypotension
|
1.6%
1/62 • Number of events 1 • 5 years
|
|
Vascular disorders
Iliac artery stenosis
|
1.6%
1/62 • Number of events 1 • 5 years
|
|
Vascular disorders
Peripheral artery aneurysm
|
1.6%
1/62 • Number of events 1 • 5 years
|
|
Vascular disorders
Peripheral artery occlusion
|
1.6%
1/62 • Number of events 1 • 5 years
|
Other adverse events
| Measure |
Endovascular Graft
n=62 participants at risk
The Zenith Low Profile AAA Endovascular Graft and ancillary components
Zenith Low Profile AAA Endovascular Graft and ancillary components: Treatment of patients with abdominal aortic, aortoiliac, or iliac aneurysms having morphology suitable for endovascular repair
|
|---|---|
|
Cardiac disorders
Arrhythmia
|
6.5%
4/62 • Number of events 4 • 5 years
|
|
General disorders
Stent-graft endoleak
|
6.5%
4/62 • Number of events 5 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review results communications from PI prior to public release and can embargo communications of trial results between 60 and 180 days from the time submitted to the sponsor for review. The sponsor can embargo publications until the sponsor has published results or 180 days has elapsed after study closure at all participating sites. The sponsor cannot restrict publication but can require changes to protect sponsor's intellectual property rights or other confidential information.
- Publication restrictions are in place
Restriction type: OTHER