The (PIVOTAL) Study

• Sponsor: Medtronic Cardiovascular (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00444821
• Collaborator: The Cleveland Clinic (Other)
• Enrollment: 728
• Locations: 65
• Arms: 2
• Duration (Months): 58.1
• Patients Per Site: 11.2
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study is to compare endovascular repair using any FDA approved Medtronic AAA Stent Graft System versus surveillance in subjects with smaller abdominal aortic aneurysms (AAA)(4-5CM), with respect to AAA rupture and AAA related deaths.

Condition or Disease	Intervention/Treatment	Phase
ABDOMINAL AORTIC ANEURYSMS	Device: AneuRx AAA stent graft / Talent AAA stent graft	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 728 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Positive Impact of Endovascular Options for Treating Aneurysms Early (PIVOTAL)
• Study Start Date: Mar 1, 2005
• Actual Primary Completion Date: Jan 1, 2010
• Actual Study Completion Date: Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Surveillance
Experimental: Early Endovascular Repair	Device: AneuRx AAA stent graft / Talent AAA stent graft; Catheter based stent graft inserted to seal off an abdominal aortic aneurysm

Outcome Measures

Primary Outcome Measures

1. Number of Subjects That Experienced Rupture or Aneurysm Related Death [3 years]

Secondary Outcome Measures

1. Aneurysm Growth >0.5 cm [1 year]

   After repair, AAA enlargement by >0.5cm

2. Secondary Endovascular Procedures Between the 30-day Post Treatment and 3-year Follow-up [study termination]

   secondary interventions in those that had successful delivery and deployment by treatment group randomized to.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 40 to 90 years of age

• Meet all indications for use as stated in the Medtronic Vascular AAA Endograft Instructions for Use

• Maximum aneurysm diameter of 4-5cm

• If female patient with child bearing potential, must have a documented negative pregnancy test within seven(7)days prior to inclusion

• Patient is willing and able to comply with the specified follow-up evaluation

• Life expectancy at least 3 years

Exclusion Criteria:

• Meet any of the Contraindications stated in the Medtronic Vascular AAA Endograft instructions for Use

• Known co-existing condition with a life expectancy of less than 3 years

• Major surgical or interventional procedure (vascular and/or non-vascular)within 30 days prior to study enrollment

• Subjects enrolled in another clinical trial or anticipated to be included into a trial, which may interfere with this study, or subjects already enrolled in this trial before.

• Planned conduit procedure for introduction of endograft

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama	Birmingham	Alabama	United States
2	Tucson Vascular Surgery	Tucson	Arizona	United States
3	University of Arizona - UMC	Tucson	Arizona	United States
4	VA Hospital	Little Rock	Arkansas	United States
5	Palomar Hospital	Escondido	California	United States
6	Long Beach VA Healthcare System	Long Beach	California	United States
7	UCLA Medical Center	Los Angeles	California	United States
8	University of Southern California	Los Angeles	California	United States
9	Stanford University VA	Palo Alto	California	United States
10	UC Davis Medical Center	Sacramento	California	United States
11	Stanford University Medical Center	Stanford	California	United States
12	University of Florida	Gainesville	Florida	United States
13	Mayo Clinic	Jacksonville	Florida	United States
14	Leesburg Regional Medical Center	Leesburg	Florida	United States
15	University of South Florida	Tampa	Florida	United States
16	St. Joseph's Research Institute	Atlanta	Georgia	United States
17	Wellstar Clinical Trials	Marietta	Georgia	United States
18	University of Chicago	Chicago	Illinois	United States
19	Decatur Memorial Hospital	Decatur	Illinois	United States
20	Adventist Midwest Health	Hinsdale	Illinois	United States
21	Southern Illinois University	Springfield	Illinois	United States
22	Cardiac Surgery Associates	Munster	Indiana	United States
23	Iowa Heart Center	Des Moines	Iowa	United States
24	Tri-State Vascular Group	Ashland	Kentucky	United States
25	Vascular Surgery Associates	Baton Rouge	Louisiana	United States
26	Vascular Surgery Associates	Bel Air	Maryland	United States
27	Brigham and Women's Hospital	Boston	Massachusetts	United States
28	Massachusetts General Hospital	Boston	Massachusetts	United States
29	University of Michigan	Ann Arbor	Michigan	United States
30	Michigan Vascular Center	Flint	Michigan	United States
31	William Beaumont Hospital	Royal Oak	Michigan	United States
32	Mayo Clinic	Rochester	Minnesota	United States
33	South Central Regional Medical Center	Laurel	Mississippi	United States
34	St. John's Regional Medical Center	Joplin	Missouri	United States
35	Albany Medical Center	Albany	New York	United States
36	Westchester Medical Center	Hawthorne	New York	United States
37	Columbia University Medical Center	New York	New York	United States
38	Staten Island University Hospital	Staten Island	New York	United States
39	Mission / St. Joseph Hospital	Asheville	North Carolina	United States
40	University of North Carolina	Chapel Hill	North Carolina	United States
41	Presbyterian Hospital	Charlotte	North Carolina	United States
42	East Carolina University	Greenville	North Carolina	United States
43	Wake Forest University School of Medicine	Winston-Salem	North Carolina	United States
44	The Lindner Clinical Trials Center	Cincinnati	Ohio	United States
45	Cleveland Clinic Foundation	Cleveland	Ohio	United States
46	Ohio State University	Columbus	Ohio	United States
47	The Dayton Heart Center	Dayton	Ohio	United States
48	Jobst Vascular Center	Toledo	Ohio	United States
49	Oregon	Medford	Oregon	United States
50	Lehigh Valley Hospital	Allentown	Pennsylvania	United States
51	UPMC Vascular Surgery	Pittsburgh	Pennsylvania	United States
52	North Central Heart Institute	Sioux Falls	South Dakota	United States
53	University Surgical Associates	Chattanooga	Tennessee	United States
54	Baptist Memorial Hospital	Memphis	Tennessee	United States
55	St. Thomas Hospital	Nashville	Tennessee	United States
56	Vanderbilt University Medical Center	Nashville	Tennessee	United States
57	Methodist Dallas Medical Center	Dallas	Texas	United States
58	UT Southwestern Medical Center	Dallas	Texas	United States
59	Baylor College of Medicine	Houston	Texas	United States
60	Wilford Hall Medical Center	Lackland Air Force Base	Texas	United States
61	Texas	Temple	Texas	United States
62	University of Virginia	Charlottesville	Virginia	United States
63	Sentara Heart Hospital	Norfolk	Virginia	United States
64	Sacred Heart Medical Center	Spokane	Washington	United States
65	Wisconsin Heart / Meriter Hospital	Madison	Wisconsin	United States

Sponsors and Collaborators

• Medtronic Cardiovascular
• The Cleveland Clinic

Investigators

• Principal Investigator: Kenneth Ouriel, MD, New York Presbyterian Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic Cardiovascular
• ClinicalTrials.gov Identifier: NCT00444821
• Other Study ID Numbers: VS-2005-01
• First Posted: Mar 8, 2007
• Last Update Posted: Oct 11, 2021
• Last Verified: Oct 1, 2021

• Keywords provided by Medtronic Cardiovascular: AAA; Aneurysm; AneuRx; Talent
• Additional relevant MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal

Study Results

Participant Flow

Arm/Group Title	Surveillance	Early Endovascular Repair
Arm/Group Description	Subjects were assigned to serial ultrasound surveillance	AneuRx AAA stent graft / Talent AAA stent graft: Catheter based stent graft inserted to seal off an abdominal aortic aneurysm
Period Title: Overall Study
STARTED	362	366
Received AAA Repair	122	326
COMPLETED	0	0
NOT COMPLETED	362	366

Baseline Characteristics

Arm/Group Title	Surveillance	Early Endovascular Repair	Total
Arm/Group Description	Subjects were assigned to serial ultrasound surveillance	AneuRx AAA stent graft / Talent AAA stent graft: Catheter based stent graft inserted to seal off an abdominal aortic aneurysm	Total of all reporting groups
Overall Participants	362	366	728
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	70.47 (7.67)	70.46 (7.80)	70.46 (7.74)
Sex: Female, Male (Count of Participants)
Female	56 15.5%	41 11.2%	97 13.3%
Male	306 84.5%	325 88.8%	631 86.7%
Race/Ethnicity, Customized (Count of Participants)
White race	343 94.8%	340 92.9%	683 93.8%
Hispanic ethnicity	7 1.9%	7 1.9%	14 1.9%
Region of Enrollment (Count of Participants)
United States	362 100%	366 100%	728 100%
Baseline AAA size (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	4.45 (0.27)	4.45 (0.27)	4.45 (0.27)

Outcome Measures

1. Primary Outcome

Title	Number of Subjects That Experienced Rupture or Aneurysm Related Death
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Study was terminated before all subjects enrolled and completed follow-up.

Arm/Group Title	Surveillance	Early Endovascular Repair
Arm/Group Description	Subjects were assigned to serial ultrasound surveillance	AneuRx AAA stent graft / Talent AAA stent graft: Catheter based stent graft inserted to seal off an abdominal aortic aneurysm
Measure Participants	362	366
Count of Participants [Participants]	2 0.6%	2 0.5%

2. Secondary Outcome

Title	Aneurysm Growth >0.5 cm
Description	After repair, AAA enlargement by >0.5cm
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Study was terminated before all subjects enrolled and completed follow-up.

Arm/Group Title	Surveillance	Early Endovascular Repair
Arm/Group Description	Subjects were assigned to serial ultrasound surveillance	AneuRx AAA stent graft / Talent AAA stent graft: Catheter based stent graft inserted to seal off an abdominal aortic aneurysm
Measure Participants	247	263
Count of Participants [Participants]	35 9.7%	15 4.1%

3. Secondary Outcome

Title	Secondary Endovascular Procedures Between the 30-day Post Treatment and 3-year Follow-up
Description	secondary interventions in those that had successful delivery and deployment by treatment group randomized to.
Time Frame	study termination

Outcome Measure Data

Analysis Population Description

Study was terminated before all subjects enrolled and completed follow-up.

Arm/Group Title	Surveillance	Early Endovascular Repair
Arm/Group Description	Subjects were assigned to serial ultrasound surveillance	AneuRx AAA stent graft / Talent AAA stent graft: Catheter based stent graft inserted to seal off an abdominal aortic aneurysm
Measure Participants	109	322
Count of Participants [Participants]	5 1.4%	12 3.3%

Adverse Events

Time Frame	SAEs were collected through study termination and non-SAEs were collected up to and including the 6 month follow-up visit. The mean follow-up was 20 months (range 0-41 months) in each treatment group.
Adverse Event Reporting Description	Adverse event is any new, undesirable medial occurrence or change (worsening) of an existing condition in a patient that occurs during treatment, whether or not considered to be associated with the AAA stent graft device. Information on all adverse events (serious and non-serious), including deaths, were recorded on the CRFs.
Arm/Group Title	Surveillance		Early Endovascular Repair
Arm/Group Description	Subjects were assigned to serial ultrasound surveillance		AneuRx AAA stent graft / Talent AAA stent graft: Catheter based stent graft inserted to seal off an abdominal aortic aneurysm
All Cause Mortality
	Surveillance		Early Endovascular Repair
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	15/362 (4.1%)		15/366 (4.1%)
Serious Adverse Events
	Surveillance		Early Endovascular Repair
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	208/362 (57.5%)		166/366 (45.4%)
Blood and lymphatic system disorders
Anemia	5/362 (1.4%)	5	3/366 (0.8%)	3
Febrile Neutropenia	0/362 (0%)	0	1/366 (0.3%)	1
Leukocytosis	0/362 (0%)	0	1/366 (0.3%)	1
Thrombocytopenia	1/362 (0.3%)	1	0/366 (0%)	0
Cardiac disorders
Acute Coronary Syndrome	1/362 (0.3%)	1	1/366 (0.3%)	1
Angina Pectoris	2/362 (0.6%)	2	3/366 (0.8%)	3
Atrial Fibrillation	6/362 (1.7%)	6	1/366 (0.3%)	1
Atrial Fibrillation With Rapid Ventricular Response	1/362 (0.3%)	1	0/366 (0%)	0
Atrial Flutter	0/362 (0%)	0	2/366 (0.5%)	3
Bradycardia	2/362 (0.6%)	2	0/366 (0%)	0
Cardiac Arrest	0/362 (0%)	0	2/366 (0.5%)	2
Cardio-Respiratory Arrest	0/362 (0%)	0	1/366 (0.3%)	1
Cardiomyopathy	0/362 (0%)	0	1/366 (0.3%)	1
Cardiopulmonary Arrest	0/362 (0%)	0	1/366 (0.3%)	1
Chest Pain Cardiac	4/362 (1.1%)	4	1/366 (0.3%)	2
Congestive Cardiac Failure Aggravated	1/362 (0.3%)	1	1/366 (0.3%)	2
Congestive Heart Failure	6/362 (1.7%)	7	6/366 (1.6%)	7
Coronary Artery Disease	1/362 (0.3%)	1	6/366 (1.6%)	6
Coronary Artery Disease Aggravated	3/362 (0.8%)	3	2/366 (0.5%)	2
Coronary Artery Disease Progression	1/362 (0.3%)	1	0/366 (0%)	0
Coronary Artery Occlusion	2/362 (0.6%)	2	1/366 (0.3%)	1
Coronary Artery Stenosis	1/362 (0.3%)	1	0/366 (0%)	0
Dilated Cardiomyopathy	1/362 (0.3%)	1	0/366 (0%)	0
Heart Attack	2/362 (0.6%)	2	1/366 (0.3%)	1
Heart Block Third Degree	0/362 (0%)	0	1/366 (0.3%)	2
Heart Failure	1/362 (0.3%)	1	0/366 (0%)	0
Non St Segment Elevation Myocardial Infarction	0/362 (0%)	0	1/366 (0.3%)	1
Non-Q Wave Mi	6/362 (1.7%)	6	6/366 (1.6%)	6
Non-Sustained Ventricular Tachycardia	1/362 (0.3%)	2	0/366 (0%)	0
Palpitations	1/362 (0.3%)	1	0/366 (0%)	0
Paroxysmal Atrial Fibrillation	1/362 (0.3%)	1	0/366 (0%)	0
Paroxysmal Atrial Flutter	0/362 (0%)	0	1/366 (0.3%)	1
Paroxysmal Atrial Tachycardia	1/362 (0.3%)	1	0/366 (0%)	0
Paroxysmal Ventricular Tachycardia	1/362 (0.3%)	1	0/366 (0%)	0
Q Wave Mi	3/362 (0.8%)	3	2/366 (0.5%)	2
Sick Sinus Syndrome	1/362 (0.3%)	1	1/366 (0.3%)	1
Sustained Ventricular Tachycardia	1/362 (0.3%)	1	0/366 (0%)	0
Tachycardia	0/362 (0%)	0	1/366 (0.3%)	1
Triple Vessel Disease	0/362 (0%)	0	1/366 (0.3%)	1
Unstable Angina	4/362 (1.1%)	4	1/366 (0.3%)	1
Ventricular Tachycardia	1/362 (0.3%)	1	1/366 (0.3%)	1
Wide Complex Tachycardia	1/362 (0.3%)	1	0/366 (0%)	0
Ear and labyrinth disorders
Benign Positional Vertigo	1/362 (0.3%)	1	0/366 (0%)	0
Eye disorders
Cataract (Left)	0/362 (0%)	0	1/366 (0.3%)	1
Gastrointestinal disorders
Abdominal Distension	0/362 (0%)	0	1/366 (0.3%)	1
Abdominal Pain	4/362 (1.1%)	4	2/366 (0.5%)	2
Bleeding Duodenal Ulcer	1/362 (0.3%)	1	0/366 (0%)	0
Bowel Ischemia	1/362 (0.3%)	1	2/366 (0.5%)	2
Chronic Abdominal Pain	0/362 (0%)	0	1/366 (0.3%)	1
Colitis	1/362 (0.3%)	1	0/366 (0%)	0
Colitis Ulcerative	0/362 (0%)	0	1/366 (0.3%)	1
Colon Perforation	0/362 (0%)	0	1/366 (0.3%)	1
Constipation	0/362 (0%)	0	1/366 (0.3%)	1
Crohns Disease Aggravated	0/362 (0%)	0	1/366 (0.3%)	1
Diaphragmatic Hernia	1/362 (0.3%)	1	0/366 (0%)	0
Diarrhea	2/362 (0.6%)	2	0/366 (0%)	0
Diverticulitis	0/362 (0%)	0	1/366 (0.3%)	1
Epigastric Discomfort	0/362 (0%)	0	1/366 (0.3%)	1
Esophagitis Ulcerative	0/362 (0%)	0	1/366 (0.3%)	1
Gastric Ulcer Perforated	0/362 (0%)	0	1/366 (0.3%)	1
Gastroesophageal Reflux Disease	1/362 (0.3%)	1	0/366 (0%)	0
Gastrointestinal Bleeding	1/362 (0.3%)	1	0/366 (0%)	0
Gerd	1/362 (0.3%)	1	0/366 (0%)	0
Gi Bleed	2/362 (0.6%)	2	2/366 (0.5%)	2
Hematemesis	0/362 (0%)	0	1/366 (0.3%)	1
Hemoperitoneum	0/362 (0%)	0	1/366 (0.3%)	1
Ileus	0/362 (0%)	0	5/366 (1.4%)	5
Incarcerated Inguinal Hernia	1/362 (0.3%)	1	0/366 (0%)	0
Inguinal Hernia	0/362 (0%)	0	1/366 (0.3%)	1
Left Lower Quadrant Pain	0/362 (0%)	0	1/366 (0.3%)	1
Lower Gastrointestinal Bleeding	0/362 (0%)	0	2/366 (0.5%)	2
Mallory Weiss Tear	0/362 (0%)	0	1/366 (0.3%)	1
Nausea	2/362 (0.6%)	2	2/366 (0.5%)	2
Nausea Aggravated	0/362 (0%)	0	1/366 (0.3%)	1
Obstipation	0/362 (0%)	0	1/366 (0.3%)	1
Rectal Bleeding	1/362 (0.3%)	1	0/366 (0%)	0
Rectus Sheath Hematoma	0/362 (0%)	0	1/366 (0.3%)	2
Ruptured Diverticulum	1/362 (0.3%)	1	0/366 (0%)	0
Small Bowel Obstruction	1/362 (0.3%)	2	2/366 (0.5%)	2
Ugi Bleed	1/362 (0.3%)	1	0/366 (0%)	0
Umbilical Hernia	1/362 (0.3%)	1	0/366 (0%)	0
Unspecified Disorder Of Intestine	1/362 (0.3%)	1	0/366 (0%)	0
Vomiting	1/362 (0.3%)	1	2/366 (0.5%)	2
General disorders
Acute Chest Pain	0/362 (0%)	0	1/366 (0.3%)	1
Acute Febrile Illness	0/362 (0%)	0	1/366 (0.3%)	1
Acute Pain	0/362 (0%)	0	1/366 (0.3%)	1
Central Line Complication	1/362 (0.3%)	1	0/366 (0%)	0
Chest Pain	8/362 (2.2%)	10	7/366 (1.9%)	10
Death	1/362 (0.3%)	1	0/366 (0%)	0
Drowning	0/362 (0%)	0	1/366 (0.3%)	1
Edema Legs	1/362 (0.3%)	1	0/366 (0%)	0
Endoleak	4/362 (1.1%)	5	3/366 (0.8%)	3
Fever	2/362 (0.6%)	2	5/366 (1.4%)	5
Fever Of Unknown Origin	3/362 (0.8%)	3	2/366 (0.5%)	2
General Malaise	2/362 (0.6%)	2	0/366 (0%)	0
Multiple Organ Failure	1/362 (0.3%)	1	3/366 (0.8%)	3
Nonspecific Chest Pain	1/362 (0.3%)	1	1/366 (0.3%)	1
Stent-Graft Endoleak Type Ii	0/362 (0%)	0	1/366 (0.3%)	1
Unspecified Chest Pain	0/362 (0%)	0	1/366 (0.3%)	1
Weakness	1/362 (0.3%)	1	0/366 (0%)	0
Hepatobiliary disorders
Acute Cholecystitis	0/362 (0%)	0	1/366 (0.3%)	2
Autoimmune Hepatitis	0/362 (0%)	0	1/366 (0.3%)	1
Cholecystitis	1/362 (0.3%)	1	0/366 (0%)	0
Cholecystolithiasis	0/362 (0%)	0	1/366 (0.3%)	1
Cholelithiasis	2/362 (0.6%)	2	0/366 (0%)	0
Common Bile Duct Stone	0/362 (0%)	0	1/366 (0.3%)	1
Liver Cirrhosis	0/362 (0%)	0	1/366 (0.3%)	1
Liver Failure	0/362 (0%)	0	1/366 (0.3%)	1
Immune system disorders
Allergic Angioedema	0/362 (0%)	0	1/366 (0.3%)	1
Allergic Reaction	0/362 (0%)	0	1/366 (0.3%)	1
Anaphylactic Shock	0/362 (0%)	0	1/366 (0.3%)	1
Anaphylaxis	1/362 (0.3%)	1	0/366 (0%)	0
Systemic Inflammatory Response Syndrome	1/362 (0.3%)	1	0/366 (0%)	0
Infections and infestations
Acute Appendicitis	0/362 (0%)	0	1/366 (0.3%)	1
Appendicitis	3/362 (0.8%)	3	1/366 (0.3%)	1
Bronchitis	3/362 (0.8%)	3	1/366 (0.3%)	1
Bronchitis Bacterial	0/362 (0%)	0	1/366 (0.3%)	1
Catheter Site Infection	0/362 (0%)	0	1/366 (0.3%)	1
Cellulitis	1/362 (0.3%)	1	2/366 (0.5%)	2
Cellulitis Of Arm	0/362 (0%)	0	1/366 (0.3%)	2
Cellulitis Of Face	0/362 (0%)	0	1/366 (0.3%)	1
Cold	0/362 (0%)	0	1/366 (0.3%)	1
Community Acquired Pneumonia	3/362 (0.8%)	4	2/366 (0.5%)	2
Gastroenteritis	0/362 (0%)	0	1/366 (0.3%)	1
Groin Abscess	2/362 (0.6%)	2	1/366 (0.3%)	1
Hospital Acquired Pneumonia	0/362 (0%)	0	1/366 (0.3%)	1
Kidney Infection	1/362 (0.3%)	1	1/366 (0.3%)	1
Lung Abscess	1/362 (0.3%)	1	0/366 (0%)	0
Mrsa Wound Infection	0/362 (0%)	0	1/366 (0.3%)	1
Orchitis	0/362 (0%)	0	1/366 (0.3%)	1
Osteomyelitis	1/362 (0.3%)	1	0/366 (0%)	0
Pneumonia	11/362 (3%)	13	10/366 (2.7%)	11
Post Procedural Pneumonia	0/362 (0%)	0	1/366 (0.3%)	1
Postoperative Infection	2/362 (0.6%)	2	0/366 (0%)	0
Pyelonephritis	1/362 (0.3%)	1	0/366 (0%)	0
Sepsis	6/362 (1.7%)	7	5/366 (1.4%)	5
Septic Shock	1/362 (0.3%)	1	0/366 (0%)	0
Surgical Wound Infection	1/362 (0.3%)	1	1/366 (0.3%)	1
Urinary Tract Infection	2/362 (0.6%)	2	4/366 (1.1%)	4
Viral Encephalitis	1/362 (0.3%)	1	0/366 (0%)	0
Viral Syndrome	1/362 (0.3%)	1	0/366 (0%)	0
Wound Infection	1/362 (0.3%)	1	3/366 (0.8%)	3
Injury, poisoning and procedural complications
Anemia Postoperative	1/362 (0.3%)	1	0/366 (0%)	0
Ankle Fracture	0/362 (0%)	0	1/366 (0.3%)	1
Automobile Accident	1/362 (0.3%)	2	0/366 (0%)	0
Back Strain	1/362 (0.3%)	1	0/366 (0%)	0
Broken Leg	0/362 (0%)	0	1/366 (0.3%)	1
Clavicle Fracture	0/362 (0%)	0	1/366 (0.3%)	1
Closed Head Injury	0/362 (0%)	0	1/366 (0.3%)	1
Fall	1/362 (0.3%)	1	2/366 (0.5%)	2
Femur Fracture	0/362 (0%)	0	1/366 (0.3%)	1
Fractured Sternum	0/362 (0%)	0	1/366 (0.3%)	1
Hip Fracture	1/362 (0.3%)	2	0/366 (0%)	0
Implantation Complication	0/362 (0%)	0	1/366 (0.3%)	1
Incision Site Complication	0/362 (0%)	0	1/366 (0.3%)	1
Injury To Pulmonary Blood Vessel	0/362 (0%)	0	1/366 (0.3%)	1
Intraoperative Bleeding	0/362 (0%)	0	1/366 (0.3%)	1
Laceration Of Blood Vessel	1/362 (0.3%)	1	0/366 (0%)	0
Liver Laceration	0/362 (0%)	0	1/366 (0.3%)	1
Lumbar Spine Compression Fracture	1/362 (0.3%)	1	0/366 (0%)	0
Motor Vehicle Accident	1/362 (0.3%)	1	2/366 (0.5%)	3
Multiple Fractures	1/362 (0.3%)	1	0/366 (0%)	0
Postoperative Hypotension	1/362 (0.3%)	1	0/366 (0%)	0
Postoperative Nausea	0/362 (0%)	0	1/366 (0.3%)	1
Rib Fracture	0/362 (0%)	0	1/366 (0.3%)	1
Seroma	0/362 (0%)	0	1/366 (0.3%)	1
Spinal Compression Fracture	0/362 (0%)	0	1/366 (0.3%)	1
Spinal Fracture	1/362 (0.3%)	1	0/366 (0%)	0
Splenic Laceration	0/362 (0%)	0	1/366 (0.3%)	1
Vascular Graft Thrombosis	7/362 (1.9%)	8	4/366 (1.1%)	4
Wound Oozing	0/362 (0%)	0	1/366 (0.3%)	1
Investigations
Creatinine Increased	1/362 (0.3%)	1	3/366 (0.8%)	3
Cystoscopy	0/362 (0%)	0	1/366 (0.3%)	1
Lung Function Decreased	1/362 (0.3%)	1	0/366 (0%)	0
Metabolism and nutrition disorders
Dehydration	2/362 (0.6%)	2	6/366 (1.6%)	6
Musculoskeletal and connective tissue disorders
Back Pain	3/362 (0.8%)	3	0/366 (0%)	0
Cervical Spinal Stenosis	1/362 (0.3%)	2	0/366 (0%)	0
Degenerative Joint Disease	1/362 (0.3%)	1	1/366 (0.3%)	1
Gonarthrosis	1/362 (0.3%)	1	0/366 (0%)	0
Gouty Arthritis	0/362 (0%)	0	1/366 (0.3%)	1
Hip Arthrosis	1/362 (0.3%)	1	0/366 (0%)	0
Hips Osteoarthritis	1/362 (0.3%)	1	1/366 (0.3%)	1
Intervertebral Disc Bulging	1/362 (0.3%)	1	0/366 (0%)	0
Jaw Pain	0/362 (0%)	0	1/366 (0.3%)	1
Knee Osteoarthritis	1/362 (0.3%)	1	1/366 (0.3%)	1
Low Back Pain	0/362 (0%)	0	1/366 (0.3%)	1
Lower Extremities Weakness Of	0/362 (0%)	0	1/366 (0.3%)	1
Lumbar Spinal Stenosis	2/362 (0.6%)	2	0/366 (0%)	0
Spinal Stenosis Cervical	1/362 (0.3%)	1	0/366 (0%)	0
Spondylolisthesis	1/362 (0.3%)	1	0/366 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma Gastric	0/362 (0%)	0	1/366 (0.3%)	1
Adenocarcinoma Of Prostate	1/362 (0.3%)	1	0/366 (0%)	0
Bladder Cancer	0/362 (0%)	0	1/366 (0.3%)	1
Brain Tumor	1/362 (0.3%)	1	0/366 (0%)	0
Cancer	2/362 (0.6%)	2	1/366 (0.3%)	1
Carcinoma Lung	1/362 (0.3%)	1	0/366 (0%)	0
Chronic Lymphocytic Leukemia	1/362 (0.3%)	1	0/366 (0%)	0
Gastric Cancer	1/362 (0.3%)	1	0/366 (0%)	0
Glioblastoma	1/362 (0.3%)	1	0/366 (0%)	0
Intraductal Papillary-Mucinous Carcinoma Of Pancreas	0/362 (0%)	0	1/366 (0.3%)	1
Liver Adenocarcinoma	1/362 (0.3%)	1	0/366 (0%)	0
Lung Cancer	1/362 (0.3%)	1	3/366 (0.8%)	3
Lung Cancer Metastatic	0/362 (0%)	0	1/366 (0.3%)	1
Lung Cancer Recurrent	1/362 (0.3%)	1	0/366 (0%)	0
Lung Carcinoma	2/362 (0.6%)	2	0/366 (0%)	0
Melanoma Skin	1/362 (0.3%)	1	0/366 (0%)	0
Merkel Cell Carcinoma	1/362 (0.3%)	2	0/366 (0%)	0
Metastatic Carcinoma	1/362 (0.3%)	1	0/366 (0%)	0
Metastatic Carcinoma Of The Bladder	1/362 (0.3%)	1	0/366 (0%)	0
Non-Small Cell Lung Cancer	1/362 (0.3%)	2	1/366 (0.3%)	1
Non-Small Cell Lung Cancer Metastatic	1/362 (0.3%)	1	1/366 (0.3%)	1
Ovarian Fibroma	1/362 (0.3%)	1	0/366 (0%)	0
Pancreatic Cancer	0/362 (0%)	0	1/366 (0.3%)	1
Prostate Cancer	0/362 (0%)	0	1/366 (0.3%)	1
Renal Cancer	0/362 (0%)	0	1/366 (0.3%)	1
Small Cell Carcinoma Of The Lung	0/362 (0%)	0	1/366 (0.3%)	1
Small Cell Lung Cancer Metastatic	0/362 (0%)	0	1/366 (0.3%)	1
Squamous Cell Carcinoma Of Lung	1/362 (0.3%)	1	0/366 (0%)	0
Nervous system disorders
Basal Ganglia Haemorrhage	0/362 (0%)	0	1/366 (0.3%)	1
Cardiac Syncope	0/362 (0%)	0	3/366 (0.8%)	3
Carotid Artery Stenosis	0/362 (0%)	0	4/366 (1.1%)	4
Cerebral Bleeding	0/362 (0%)	0	1/366 (0.3%)	1
Cerebral Edema	1/362 (0.3%)	1	0/366 (0%)	0
Cva	7/362 (1.9%)	7	4/366 (1.1%)	5
Dizziness	1/362 (0.3%)	1	0/366 (0%)	0
Embolic Stroke	0/362 (0%)	0	1/366 (0.3%)	1
Headache Recurrent	1/362 (0.3%)	1	0/366 (0%)	0
Intracerebral Hemorrhage	1/362 (0.3%)	1	0/366 (0%)	0
Metabolic Encephalopathy	0/362 (0%)	0	1/366 (0.3%)	1
Migraine Headache	1/362 (0.3%)	1	0/366 (0%)	0
Near Syncope	0/362 (0%)	0	2/366 (0.5%)	2
Paralysis	0/362 (0%)	0	1/366 (0.3%)	1
Paresthesia Lower Limb	0/362 (0%)	0	1/366 (0.3%)	1
Parkinson's Disease	1/362 (0.3%)	1	0/366 (0%)	0
Pontine Haemorrhage	1/362 (0.3%)	1	0/366 (0%)	0
Sciatica	1/362 (0.3%)	1	0/366 (0%)	0
Stroke	1/362 (0.3%)	1	0/366 (0%)	0
Subarachnoid Hemorrhage	1/362 (0.3%)	1	1/366 (0.3%)	1
Syncope	2/362 (0.6%)	2	4/366 (1.1%)	4
Tia	4/362 (1.1%)	4	2/366 (0.5%)	2
Vagal Reaction	0/362 (0%)	0	1/366 (0.3%)	1
Product Issues
Stent-Graft Migration	0/362 (0%)	0	1/366 (0.3%)	1
Psychiatric disorders
Anxiety Depression	1/362 (0.3%)	1	0/366 (0%)	0
Anxiety Due To General Medical Condition	5/362 (1.4%)	5	0/366 (0%)	0
Mental Status Changes	1/362 (0.3%)	1	0/366 (0%)	0
Post-Traumatic Stress Disorder	1/362 (0.3%)	1	0/366 (0%)	0
Stress	1/362 (0.3%)	1	0/366 (0%)	0
Substance-Induced Mood Disorder	0/362 (0%)	0	1/366 (0.3%)	1
Suicide Attempt	1/362 (0.3%)	1	0/366 (0%)	0
Renal and urinary disorders
Acute Renal Failure	2/362 (0.6%)	2	2/366 (0.5%)	2
End Stage Renal Disease (Esrd)	0/362 (0%)	0	1/366 (0.3%)	1
Hydronephrosis	1/362 (0.3%)	1	0/366 (0%)	0
Kidney Stone	1/362 (0.3%)	1	1/366 (0.3%)	1
Renal Artery Occlusion	0/362 (0%)	0	1/366 (0.3%)	1
Renal Disorder Nos	0/362 (0%)	0	1/366 (0.3%)	1
Renal Failure Aggravated	1/362 (0.3%)	1	0/366 (0%)	0
Renal Infarct	0/362 (0%)	0	1/366 (0.3%)	1
Renal Insufficiency	0/362 (0%)	0	1/366 (0.3%)	1
Ureteral Calculus	1/362 (0.3%)	1	0/366 (0%)	0
Urinary Retention	0/362 (0%)	0	1/366 (0.3%)	1
Voiding Difficulty	0/362 (0%)	0	1/366 (0.3%)	1
Reproductive system and breast disorders
Benign Prostatic Hypertrophy	1/362 (0.3%)	1	1/366 (0.3%)	1
Enlarged Prostate	1/362 (0.3%)	1	0/366 (0%)	0
Prostatitis	1/362 (0.3%)	1	0/366 (0%)	0
Scrotal Swelling	1/362 (0.3%)	1	0/366 (0%)	0
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome	0/362 (0%)	0	1/366 (0.3%)	1
Acute Respiratory Failure	0/362 (0%)	0	1/366 (0.3%)	1
Chronic Obstructive Airways Disease Exacerbated	2/362 (0.6%)	3	0/366 (0%)	0
Chronic Obstructive Pulmonary Disease	0/362 (0%)	0	1/366 (0.3%)	1
Copd Exacerbation	7/362 (1.9%)	9	8/366 (2.2%)	12
Cough	0/362 (0%)	0	1/366 (0.3%)	1
Dyspnea	1/362 (0.3%)	1	0/366 (0%)	0
Epistaxis	0/362 (0%)	0	1/366 (0.3%)	1
Hemoptysis	1/362 (0.3%)	1	0/366 (0%)	0
Hypoxia	0/362 (0%)	0	1/366 (0.3%)	1
Lung Nodule	1/362 (0.3%)	1	0/366 (0%)	0
Nosebleed	0/362 (0%)	0	1/366 (0.3%)	1
Pleural Effusion	0/362 (0%)	0	2/366 (0.5%)	2
Pneumonitis	0/362 (0%)	0	1/366 (0.3%)	1
Pulmonary Edema	1/362 (0.3%)	1	1/366 (0.3%)	1
Pulmonary Embolism	6/362 (1.7%)	6	0/366 (0%)	0
Respiratory Disorder Nos	1/362 (0.3%)	1	0/366 (0%)	0
Respiratory Failure	0/362 (0%)	0	3/366 (0.8%)	3
Respiratory Insufficiency	1/362 (0.3%)	1	0/366 (0%)	0
Shortness Of Breath	4/362 (1.1%)	5	5/366 (1.4%)	7
Subacute Pulmonary Edema	0/362 (0%)	0	1/366 (0.3%)	1
Skin and subcutaneous tissue disorders
Decubitus Ulcer	0/362 (0%)	0	1/366 (0.3%)	1
Urticaria	0/362 (0%)	0	1/366 (0.3%)	1
Surgical and medical procedures
Anal Skin Tag Excision	0/362 (0%)	0	1/366 (0.3%)	1
Aortic Aneurysm Repair	5/362 (1.4%)	5	0/366 (0%)	0
Back Surgery	1/362 (0.3%)	1	0/366 (0%)	0
Cardiac Catheterization	1/362 (0.3%)	1	2/366 (0.5%)	2
Carotid Endarterectomy	0/362 (0%)	0	2/366 (0.5%)	2
Cholecystectomy	0/362 (0%)	0	1/366 (0.3%)	1
Colostomy Closure	0/362 (0%)	0	1/366 (0.3%)	1
Coronary Arterial Stent Insertion	1/362 (0.3%)	1	0/366 (0%)	0
Coronary Artery Bypass	0/362 (0%)	0	1/366 (0.3%)	1
Craniotomy	1/362 (0.3%)	1	0/366 (0%)	0
Hemodialysis	0/362 (0%)	0	4/366 (1.1%)	5
Hernia Repair	1/362 (0.3%)	1	0/366 (0%)	0
Hip Replacement	0/362 (0%)	0	1/366 (0.3%)	1
Hospitalisation	1/362 (0.3%)	1	0/366 (0%)	0
Implantable Defibrillator Insertion	1/362 (0.3%)	1	1/366 (0.3%)	1
Intubation	0/362 (0%)	0	2/366 (0.5%)	2
Knee Surgery	1/362 (0.3%)	1	1/366 (0.3%)	1
Lung Lobectomy	0/362 (0%)	0	2/366 (0.5%)	2
Open Reduction Of Fracture	0/362 (0%)	0	1/366 (0.3%)	1
Open Reduction Of Fracture With Internal Fixation	0/362 (0%)	0	1/366 (0.3%)	1
Pseudophakia	1/362 (0.3%)	1	0/366 (0%)	0
Rehabilitation Therapy	0/362 (0%)	0	1/366 (0.3%)	1
Surgical Intervention	6/362 (1.7%)	6	4/366 (1.1%)	4
Triple Vessel Bypass Graft	0/362 (0%)	0	1/366 (0.3%)	1
Vascular Stent Insertion	1/362 (0.3%)	1	0/366 (0%)	0
Vascular disorders
Abdominal Aortic Aneurysm	34/362 (9.4%)	34	1/366 (0.3%)	1
Abdominal Aortic Aneurysm Enlargement	86/362 (23.8%)	86	0/366 (0%)	0
Acute Hypotension	0/362 (0%)	0	1/366 (0.3%)	1
Aneursym	1/362 (0.3%)	1	0/366 (0%)	0
Aneurysm	0/362 (0%)	0	1/366 (0.3%)	1
Aneurysm Enlargement	1/362 (0.3%)	1	0/366 (0%)	0
Aneurysm Ruptured	1/362 (0.3%)	1	0/366 (0%)	0
Arterial Occlusion	1/362 (0.3%)	1	0/366 (0%)	0
Ascending Aortic Dissection	0/362 (0%)	0	1/366 (0.3%)	1
Carotid Artery Stenosis	4/362 (1.1%)	4	0/366 (0%)	0
Claudication	1/362 (0.3%)	1	2/366 (0.5%)	2
Dvt	1/362 (0.3%)	1	2/366 (0.5%)	2
Femoral Artery Thrombosis	1/362 (0.3%)	1	0/366 (0%)	0
Groin Hematoma	0/362 (0%)	0	1/366 (0.3%)	1
Hypertension	1/362 (0.3%)	1	0/366 (0%)	0
Hypotension	2/362 (0.6%)	2	3/366 (0.8%)	3
Iliac Artery Rupture	1/362 (0.3%)	1	0/366 (0%)	0
Iliac Artery Stenosis	0/362 (0%)	0	1/366 (0.3%)	1
Leg Ischemia	1/362 (0.3%)	1	0/366 (0%)	0
Low Blood Pressure	1/362 (0.3%)	1	0/366 (0%)	0
Peipheral Artery Aneurysm	1/362 (0.3%)	1	0/366 (0%)	0
Peripheral Vascular Disease	1/362 (0.3%)	1	1/366 (0.3%)	1
Popliteal Artery Aneurysm	1/362 (0.3%)	1	0/366 (0%)	0
Popliteal Artery Occlusion	0/362 (0%)	0	1/366 (0.3%)	1
Thrombosis	1/362 (0.3%)	1	0/366 (0%)	0
Vascular Disorder	2/362 (0.6%)	2	5/366 (1.4%)	5
Venous Stasis Ulcer	1/362 (0.3%)	1	0/366 (0%)	0
Other (Not Including Serious) Adverse Events
	Surveillance		Early Endovascular Repair
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	21/362 (5.8%)		40/366 (10.9%)
General disorders
Endoleak	21/362 (5.8%)	21	40/366 (10.9%)	47

Limitations/Caveats

Terminated before subjects enrolled & completed follow-up, leading to small numbers. Crossover from the Surveillance Group to Early Endovascular Group led to subjects treated endovascularly being included in the Surveillance Group results.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.