Zenith(R) Low Profile AAA Endovascular Graft Clinical Study | NCT00833924

ID	Type	Description	Link
370016

Label	Type	Description	Intervention Names
1	Other	Treatment with Endovascular Graft	Device: Zenith(R) Low Profile AAA Endovascular Graft

Name	Type	Description	Arm Group Labels	Other Names
Zenith(R) Low Profile AAA Endovascular Graft	Device	The Zenith(R) 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.

Measure	Description	Time Frame
Patients With Major Adverse Events (MAE)	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.	30-day
Patients With Device Failures	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.	12-month

Name	Affiliation	Role
Ronald Fairman, MD	University of Pennsylvania	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of California, San Francisco, Div. Vascular Surgery and San Francisco VAMC		San Francisco	California	94143	United States

ID	Title	Description
FG000	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.

ID	Title	Description
BG000	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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Analyses

Primary

Patients With Major Adverse Events (MAE)

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.

1 patient experienced a re-intubation, which was adjudicated by the CEC as not related to AAA repair (related to a pre-existing condition).

Posted

Number

participants

30-day

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000120

Title

Denominators

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Title	Measurements
	OG0001

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000	Null hypothesis: The 30-day Freedom from MAE for patients treated with the Zenith® Low Profile AAA Endovascular Graft does not meet the performance goal (88%).	Exact binomial test		<0.01		Rate of 30-day freedom from MAE	99.2			2-Sided	95	95.4	100					Superiority or Other

Primary

Patients With Device Failures

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.

There were 5 patients died, and 2 patients withdrew.

Posted

Number

participants

12-month

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Assessment Type	Notes	Statistical Information
Anemia	Blood and lymphatic system disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Hypoglycemia	Blood and lymphatic system disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Iron deficiency anemia requiring transfusion	Blood and lymphatic system disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Leukocytosis with fever	Blood and lymphatic system disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Low hemoglobin (6.9) transfused 2 units packed red blood cells (PRBC)	Blood and lymphatic system disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Arrhythmia requiring intervention or new treatment	Cardiac disorders	Systematic Assessment		EG0005 events5 affected120 at risk
Bradycardia	Cardiac disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Cardiac event involving arrest, resuscitation, or balloon pump	Cardiac disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Cardiac ischemia requiring intervention	Cardiac disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Chest discomfort	Cardiac disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Chest pain requiring hospital admission and cardiac catheterization	Cardiac disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Congestive Heart Failure	Cardiac disorders	Systematic Assessment		EG0003 events3 affected120 at risk
Episode of supraventricular tachycardia	Cardiac disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Hypertension	Cardiac disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Hypotension	Cardiac disorders	Systematic Assessment		EG0002 events1 affected120 at risk
New onset sinus tachycardia	Cardiac disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Non-cardiac chest pain	Cardiac disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Syncope due to symptomatic bradycardia	Cardiac disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Uncontrolled hypertension	Cardiac disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Upgrade of an implantable cardioverter (ICD) to a BIV ICD as well as implantation of a new ICD lead	Cardiac disorders	Systematic Assessment	BIV stands for biventricular	EG0001 events1 affected120 at risk
Cataract removal (left eye)	Eye disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Abdominal incisional hernia repair	Gastrointestinal disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Abdominal pain, distention, hematemesis	Gastrointestinal disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Abdominal wall seroma	Gastrointestinal disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Abscess	Gastrointestinal disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Acute diverticulitis in the descending colon	Gastrointestinal disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Aspiration with paraesophageal hernia	Gastrointestinal disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Bowel resection	Gastrointestinal disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Cellulitis to the abdominal wall	Gastrointestinal disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Gastritis with epigastric pain	Gastrointestinal disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Gastrointestinal bleeding requiring treatment	Gastrointestinal disorders	Systematic Assessment		EG0002 events2 affected120 at risk
Gastrointestinal infection requiring treatment	Gastrointestinal disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Possible colonic ileus	Gastrointestinal disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Right inguinal hernia	Gastrointestinal disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Cellulitis	Infections and infestations	Systematic Assessment		EG0001 events1 affected120 at risk
Sepsis	Infections and infestations	Systematic Assessment		EG0003 events3 affected120 at risk
Complication requiring return to operating room (OR)	Injury, poisoning and procedural complications	Systematic Assessment		EG0001 events1 affected120 at risk
Penile/bilateral groin ecchymosis/swelling	Injury, poisoning and procedural complications	Systematic Assessment		EG0001 events1 affected120 at risk
Perineal wound discharge after resection of rectum	Injury, poisoning and procedural complications	Systematic Assessment		EG0001 events1 affected120 at risk
Fall resulting in rib fracture and closed fracture of acetabulum	Injury, poisoning and procedural complications	Systematic Assessment		EG0001 events1 affected120 at risk
Seroma requiring treatment	Injury, poisoning and procedural complications	Systematic Assessment		EG0001 events1 affected120 at risk
Wound infection requiring antibiotic treatment	Injury, poisoning and procedural complications	Systematic Assessment		EG0004 events4 affected120 at risk
Found to have diabetes	Metabolism and nutrition disorders	Systematic Assessment		EG0001 events1 affected120 at risk
New diagnosis of hyperthyroidism	Metabolism and nutrition disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Left hip pain due to degeneration of hip joint	Musculoskeletal and connective tissue disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Left knee degenerative joint disease	Musculoskeletal and connective tissue disorders	Systematic Assessment		EG0002 events2 affected120 at risk
Pain left calf on exertion	Musculoskeletal and connective tissue disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment		EG0001 events1 affected120 at risk
Prostate cancer diagnosed by biopsy	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment		EG0001 events1 affected120 at risk
T1 grade 3 urothelial carcinoma of the bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment		EG0001 events1 affected120 at risk
Altered mental status	Nervous system disorders	Systematic Assessment		EG0002 events2 affected120 at risk
Encephalopathy	Nervous system disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Left partial third nerve palsy. Diplopia.	Nervous system disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Paresthesias associated with limb ischemia	Nervous system disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Stroke	Nervous system disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Acute renal failure	Renal and urinary disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Hematuria	Renal and urinary disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Kidney stone	Renal and urinary disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Left renal atrophy and scarring	Renal and urinary disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Penile cellulitis	Renal and urinary disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Renal failure requiring dialysis	Renal and urinary disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Retention of urine	Renal and urinary disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Right nephrectomy	Renal and urinary disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Serum creatinine rise > 30% above baseline resulting in a persistent value > 2.0 mg/dl	Renal and urinary disorders	Systematic Assessment		EG0002 events2 affected120 at risk
Urethral stricture	Renal and urinary disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Urinary retention	Renal and urinary disorders	Systematic Assessment		EG0002 events2 affected120 at risk
Urinary tract infection (UTI) requiring antibiotic treatment	Renal and urinary disorders	Systematic Assessment		EG0007 events6 affected120 at risk
Epididymitis and fever	Reproductive system and breast disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Right hydrocele	Reproductive system and breast disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Acute chronic obstructive pulmonary disease (COPD) exacerbation	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Exacerbation of asthma	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Hypoxemia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Increased dyspnea leading to new diagnosis of sleep apnea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0001 events1 affected120 at risk
New 7.7 cm right upper lung zone mass concerning for neoplasm	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0001 events1 affected120 at risk
New diagnosis of sleep apnea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Persistent left lung atelectasis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Pleural effusion requiring treatment	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Pnuemonia requiring antibiotics	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0005 events5 affected120 at risk
Pulmonary event requiring tracheostomy or chest tube	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Re-intubation	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0003 events1 affected120 at risk
Shortness of breath with right swollen extremity	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Percutaneous endoscopic gastrostomy (PEG) placement	Surgical and medical procedures	Systematic Assessment		EG0001 events1 affected120 at risk
Arterial thrombosis in graft	Vascular disorders	Systematic Assessment		EG00011 events9 affected120 at risk
Arterial thrombosis in native artery	Vascular disorders	Systematic Assessment		EG0003 events3 affected120 at risk
Bilateral popliteal aneurysms/left side thrombosed	Vascular disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Claudication	Vascular disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Clotted left superficial femoral artery (LSFA) to post-tibial bypass graft	Vascular disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Embolization resulting in tissue loss or requiring intervention	Vascular disorders	Systematic Assessment		EG0007 events5 affected120 at risk
Hematoma	Vascular disorders	Systematic Assessment		EG0002 events2 affected120 at risk
Hematoma requiring surgical repair	Vascular disorders	Systematic Assessment		EG0002 events1 affected120 at risk
Left lower extremity aneurysm	Vascular disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Low systolic blood pressure: 70 recorded on 10/14/09	Vascular disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Non-occlusive graft thrombus	Vascular disorders	Systematic Assessment		EG00010 events9 affected120 at risk
Patient became hypotensive upon anesthesia induction - sustained	Vascular disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Post-procedure transfusion	Vascular disorders	Systematic Assessment		EG0006 events6 affected120 at risk
Right leg pulselessness	Vascular disorders	Systematic Assessment		EG0001 events1 affected120 at risk
Vascular injury	Vascular disorders	Systematic Assessment		EG0003 events3 affected120 at risk

ID	Term
D017544	Aortic Aneurysm, Abdominal
D017543	Iliac Aneurysm

ID	Term
D001014	Aortic Aneurysm
D000783	Aneurysm
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D001018	Aortic Diseases