Trial Outcomes & Findings for Zenith(R) Low Profile AAA Endovascular Graft Clinical Study (NCT NCT00833924)
NCT ID: NCT00833924
Last Updated: 2018-04-04
Results Overview
MAE is defined as any occurrence of all-cause death, Q-wave myocardial infarction (MI), renal failure requiring dialysis, paralysis, stroke, bowel ischemia, or re-intubation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
30-day
Results posted on
2018-04-04
Participant Flow
Participant milestones
| Measure |
Zenith® Low Profile AAA Endovascular Graft
The Zenith® Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.
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|---|---|
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Overall Study
STARTED
|
120
|
|
Overall Study
30-day
|
120
|
|
Overall Study
12-month
|
113
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
109
|
Reasons for withdrawal
| Measure |
Zenith® Low Profile AAA Endovascular Graft
The Zenith® Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.
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|---|---|
|
Overall Study
Death
|
21
|
|
Overall Study
Conversion
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Withdrawal by Subject
|
13
|
|
Overall Study
In study follow-up
|
71
|
Baseline Characteristics
Zenith(R) Low Profile AAA Endovascular Graft Clinical Study
Baseline characteristics by cohort
| Measure |
Zenith® Low Profile AAA Endovascular Graft
n=120 Participants
The Zenith® Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.
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|---|---|
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Age, Continuous
|
71.8 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
104 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30-dayPopulation: 1 patient experienced a re-intubation, which was adjudicated by the CEC as not related to AAA repair (related to a pre-existing condition).
MAE is defined as any occurrence of all-cause death, Q-wave myocardial infarction (MI), renal failure requiring dialysis, paralysis, stroke, bowel ischemia, or re-intubation.
Outcome measures
| Measure |
Zenith® Low Profile AAA Endovascular Graft
n=120 Participants
The Zenith® Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.
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|---|---|
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Patients With Major Adverse Events (MAE)
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1 participants
|
PRIMARY outcome
Timeframe: 12-monthPopulation: There were 5 patients died, and 2 patients withdrew.
Device success at 12-month is defined as: Technical Success (successful access of the aneurysm site, deployment of the graft in the intended location, and patency of the graft at the time of deployment completion intra-operatively), and freedom from the following at 12 months: Type I or type III endoleaks requiring re-intervention, Aneurysm rupture or conversion to open surgical repair, and Aneurysm enlargement greater than 0.5 cm.
Outcome measures
| Measure |
Zenith® Low Profile AAA Endovascular Graft
n=113 Participants
The Zenith® Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.
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|---|---|
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Patients With Device Failures
Converted to open surgical repair
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1 participants
|
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Patients With Device Failures
Aneurysm expansion > 5 mm
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2 participants
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Adverse Events
Zenith® Low Profile AAA Endovascular Graft
Serious events: 63 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Zenith® Low Profile AAA Endovascular Graft
n=120 participants at risk
The Zenith® Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.
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|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Blood and lymphatic system disorders
Hypoglycemia
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Blood and lymphatic system disorders
Iron deficiency anemia requiring transfusion
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Blood and lymphatic system disorders
Leukocytosis with fever
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Blood and lymphatic system disorders
Low hemoglobin (6.9) transfused 2 units packed red blood cells (PRBC)
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Cardiac disorders
Arrhythmia requiring intervention or new treatment
|
4.2%
5/120 • Number of events 5 • 365 days
|
|
Cardiac disorders
Bradycardia
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Cardiac disorders
Cardiac event involving arrest, resuscitation, or balloon pump
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Cardiac disorders
Cardiac ischemia requiring intervention
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Cardiac disorders
Chest discomfort
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Cardiac disorders
Chest pain requiring hospital admission and cardiac catheterization
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Cardiac disorders
Congestive Heart Failure
|
2.5%
3/120 • Number of events 3 • 365 days
|
|
Cardiac disorders
Episode of supraventricular tachycardia
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Cardiac disorders
Hypertension
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Cardiac disorders
Hypotension
|
0.83%
1/120 • Number of events 2 • 365 days
|
|
Cardiac disorders
New onset sinus tachycardia
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Cardiac disorders
Non-cardiac chest pain
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Cardiac disorders
Syncope due to symptomatic bradycardia
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Cardiac disorders
Uncontrolled hypertension
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Cardiac disorders
Upgrade of an implantable cardioverter (ICD) to a BIV ICD as well as implantation of a new ICD lead
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Eye disorders
Cataract removal (left eye)
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Gastrointestinal disorders
Abdominal incisional hernia repair
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Gastrointestinal disorders
Abdominal pain, distention, hematemesis
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Gastrointestinal disorders
Abdominal wall seroma
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Gastrointestinal disorders
Abscess
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Gastrointestinal disorders
Acute diverticulitis in the descending colon
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Gastrointestinal disorders
Aspiration with paraesophageal hernia
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Gastrointestinal disorders
Bowel resection
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Gastrointestinal disorders
Cellulitis to the abdominal wall
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Gastrointestinal disorders
Gastritis with epigastric pain
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Gastrointestinal disorders
Gastrointestinal bleeding requiring treatment
|
1.7%
2/120 • Number of events 2 • 365 days
|
|
Gastrointestinal disorders
Gastrointestinal infection requiring treatment
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Gastrointestinal disorders
Possible colonic ileus
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Gastrointestinal disorders
Right inguinal hernia
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Infections and infestations
Cellulitis
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Infections and infestations
Sepsis
|
2.5%
3/120 • Number of events 3 • 365 days
|
|
Injury, poisoning and procedural complications
Complication requiring return to operating room (OR)
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Injury, poisoning and procedural complications
Penile/bilateral groin ecchymosis/swelling
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Injury, poisoning and procedural complications
Perineal wound discharge after resection of rectum
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Injury, poisoning and procedural complications
Fall resulting in rib fracture and closed fracture of acetabulum
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Injury, poisoning and procedural complications
Seroma requiring treatment
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Injury, poisoning and procedural complications
Wound infection requiring antibiotic treatment
|
3.3%
4/120 • Number of events 4 • 365 days
|
|
Metabolism and nutrition disorders
Found to have diabetes
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Metabolism and nutrition disorders
New diagnosis of hyperthyroidism
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Musculoskeletal and connective tissue disorders
Left hip pain due to degeneration of hip joint
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Musculoskeletal and connective tissue disorders
Left knee degenerative joint disease
|
1.7%
2/120 • Number of events 2 • 365 days
|
|
Musculoskeletal and connective tissue disorders
Pain left calf on exertion
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer diagnosed by biopsy
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T1 grade 3 urothelial carcinoma of the bladder
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Nervous system disorders
Altered mental status
|
1.7%
2/120 • Number of events 2 • 365 days
|
|
Nervous system disorders
Encephalopathy
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Nervous system disorders
Left partial third nerve palsy. Diplopia.
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Nervous system disorders
Paresthesias associated with limb ischemia
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Nervous system disorders
Stroke
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Renal and urinary disorders
Acute renal failure
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Renal and urinary disorders
Hematuria
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Renal and urinary disorders
Kidney stone
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Renal and urinary disorders
Left renal atrophy and scarring
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Renal and urinary disorders
Penile cellulitis
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Renal and urinary disorders
Renal failure requiring dialysis
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Renal and urinary disorders
Retention of urine
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Renal and urinary disorders
Right nephrectomy
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Renal and urinary disorders
Serum creatinine rise > 30% above baseline resulting in a persistent value > 2.0 mg/dl
|
1.7%
2/120 • Number of events 2 • 365 days
|
|
Renal and urinary disorders
Urethral stricture
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Renal and urinary disorders
Urinary retention
|
1.7%
2/120 • Number of events 2 • 365 days
|
|
Renal and urinary disorders
Urinary tract infection (UTI) requiring antibiotic treatment
|
5.0%
6/120 • Number of events 7 • 365 days
|
|
Reproductive system and breast disorders
Epididymitis and fever
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Reproductive system and breast disorders
Right hydrocele
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute chronic obstructive pulmonary disease (COPD) exacerbation
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Exacerbation of asthma
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxemia
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Increased dyspnea leading to new diagnosis of sleep apnea
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
New 7.7 cm right upper lung zone mass concerning for neoplasm
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
New diagnosis of sleep apnea
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Persistent left lung atelectasis
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion requiring treatment
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Pnuemonia requiring antibiotics
|
4.2%
5/120 • Number of events 5 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary event requiring tracheostomy or chest tube
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Re-intubation
|
0.83%
1/120 • Number of events 3 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath with right swollen extremity
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Surgical and medical procedures
Percutaneous endoscopic gastrostomy (PEG) placement
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Vascular disorders
Arterial thrombosis in graft
|
7.5%
9/120 • Number of events 11 • 365 days
|
|
Vascular disorders
Arterial thrombosis in native artery
|
2.5%
3/120 • Number of events 3 • 365 days
|
|
Vascular disorders
Bilateral popliteal aneurysms/left side thrombosed
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Vascular disorders
Claudication
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Vascular disorders
Clotted left superficial femoral artery (LSFA) to post-tibial bypass graft
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Vascular disorders
Embolization resulting in tissue loss or requiring intervention
|
4.2%
5/120 • Number of events 7 • 365 days
|
|
Vascular disorders
Hematoma
|
1.7%
2/120 • Number of events 2 • 365 days
|
|
Vascular disorders
Hematoma requiring surgical repair
|
0.83%
1/120 • Number of events 2 • 365 days
|
|
Vascular disorders
Left lower extremity aneurysm
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Vascular disorders
Low systolic blood pressure: 70 recorded on 10/14/09
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Vascular disorders
Non-occlusive graft thrombus
|
7.5%
9/120 • Number of events 10 • 365 days
|
|
Vascular disorders
Patient became hypotensive upon anesthesia induction - sustained
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Vascular disorders
Post-procedure transfusion
|
5.0%
6/120 • Number of events 6 • 365 days
|
|
Vascular disorders
Right leg pulselessness
|
0.83%
1/120 • Number of events 1 • 365 days
|
|
Vascular disorders
Vascular injury
|
2.5%
3/120 • Number of events 3 • 365 days
|
Other adverse events
| Measure |
Zenith® Low Profile AAA Endovascular Graft
n=120 participants at risk
The Zenith® Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.
|
|---|---|
|
Vascular disorders
Post-procedure transfusion
|
6.7%
8/120 • Number of events 8 • 365 days
|
Additional Information
Scott Snyder, PhD, Director of Clinical Science & Biostatistics
Cook Research Incorporated
Phone: 765-463-7537
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60