Endurant Bifurcated and Aorto-Uni-Iliac (AUI) Stent Graft... | NCT00705718

Label	Type	Description	Intervention Names
Endurant Bifurcated arm	Experimental	The Bifurcated arm includes subjects who have received a bifurcated device. The Endurant Stent Graft System Bifurcated device is administered to treat patients with an Abdominal Aortic Aneurysm.	Device: Endurant Stent Graft System
Endurant AUI arm	Experimental	The AUI arm includes subjects who have received an AUI device. The Endurant Stent Graft System AUI device is administered to treat patients with an Abdominal Aortic Aneurysm.	Device: Endurant Stent Graft System

Name	Type	Description	Arm Group Labels	Other Names
Endurant Stent Graft System	Device	Abdominal Aortic Aneurysm Repair	Endurant AUI arm Endurant Bifurcated arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary Safety Endpoint (Freedom From MAEs Within 30 Days of Index Procedure)	The primary safety endpoint is composite defined as the proportion of subjects free from major adverse events (MAE) within 1 month (day 0 - Day 30)of implant is non-inferior to the proportion of subjects free from MAEs in the Talent Control Group. The endpoint is defined as the proportion of subjects free from occurence of a MAE within 1 month of the implantation of the Endurant Stent Graft. The major adverse events composite endpoint which will be evaluated at 1 month post implant includes the occurrence of any of the following events. All-Cause Mortality Bowel Ischemia Myocardial Infarction Paraplegia Procedural Blood Loss > or equal to 1000 cc Renal Failure Respiratory Failure Stroke	30 days (Safety)
Major Adverse Events Within 30 Days of Index Procedure	The primary safety endpoint is composite defined as the proportion of subjects free from major adverse events (MAE) within 1 month (day 0 - Day 30)of implant is non-inferior to the proportion of subjects free from MAEs in the Talent Control Group. The endpoint is defined as the proportion of subjects free from occurence of a MAE within 1 month of the implantation of the Endurant Stent Graft. The major adverse events composite endpoint which will be evaluated at 1 month post implant includes the occurrence of any of the following events. All-Cause Mortality Bowel Ischemia Myocardial Infarction Paraplegia Procedural Blood Loss > or equal to 1000 cc Renal Failure Respiratory Failure Stroke	30 days
Primary Effectiveness Endpoint (Technical Success)	Technical success defined as successful delivery and deployment of the stent graft in the planned location and with no unintentional coverage of both the internal iliac arteries or any visceral aortic branches and with removal of the system. Technical success was assessed intra-operatively.	Intra-operatively
Primary Effectiveness Endpoint (Treatment Success)

Secondary Outcomes

Measure	Description	Time Frame
Secondary Endpoints - Safety Evaluation	The following secondary endpoints were included in the Pivotal trial to evaluate the safety profile of the Endurant Stent Graft System. Aneurysm-Related Mortality through 12 months All-Cause Mortality with 30 days All-Cause Mortality within 12 months Major Adverse Events through 12 months Adverse Events through 12 months Unanticipated Adverse Device Events Serious Adverse Events (SAEs) As reported at the time of the data cut off. Device Related Adverse Events Procedure Related Adverse Events Adverse Events (excluding SAEs)

Eligibility Module

Name	Affiliation	Role
Michel S Makaroun, MD	Division of Vascular Surgery University of Pittsburgh Medical Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama Hospitals		Birmingham	Alabama	35294	United States
Arizona Heart Institute

ID	Title	Description
FG000	Endurant AUI Arm	Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
FG001	Endurant Bifurcated Arm	Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Primary Safety Endpoint (Freedom From MAEs Within 30 Days of Index Procedure)

The primary safety endpoint is composite defined as the proportion of subjects free from major adverse events (MAE) within 1 month (day 0 - Day 30)of implant is non-inferior to the proportion of subjects free from MAEs in the Talent Control Group. The endpoint is defined as the proportion of subjects free from occurence of a MAE within 1 month of the implantation of the Endurant Stent Graft. The major adverse events composite endpoint which will be evaluated at 1 month post implant includes the occurrence of any of the following events.

All-Cause Mortality
Bowel Ischemia
Myocardial Infarction
Paraplegia
Procedural Blood Loss > or equal to 1000 cc
Renal Failure
Respiratory Failure
Stroke

Freedom from Major Adverse Events within 30 Days of Implant

Posted

Number

percentage of participants

30 days (Safety)

ID	Title	Description
OG000	Endurant AUI Arm	Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
OG001	Endurant Bifurcated Arm	Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair

Units	Counts
Participants	OG00044 OG001150

Title

Denominators

Categories

Title	Measurements
	OG00088.6 OG00196.0

Primary

Major Adverse Events Within 30 Days of Index Procedure

All-Cause Mortality
Bowel Ischemia
Myocardial Infarction
Paraplegia
Procedural Blood Loss > or equal to 1000 cc
Renal Failure
Respiratory Failure
Stroke

Posted

Number

percentage of participants

30 days

ID	Title	Description
OG000	Endurant AUI Arm	Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
OG001	Endurant Bifurcated Arm	Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair

Units	Counts
Participants

Secondary

Secondary Endpoints - Safety Evaluation

The following secondary endpoints were included in the Pivotal trial to evaluate the safety profile of the Endurant Stent Graft System.

Aneurysm-Related Mortality through 12 months
All-Cause Mortality with 30 days
All-Cause Mortality within 12 months
Major Adverse Events through 12 months
Adverse Events through 12 months
Unanticipated Adverse Device Events
Serious Adverse Events (SAEs) As reported at the time of the data cut off.
Device Related Adverse Events
Procedure Related Adverse Events
Adverse Events (excluding SAEs)

Number of subjects enrolled in the study arm

Posted

Number

percentage of evaluable participants

12 months

ID	Title	Description
OG000	Endurant AUI Arm	Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
OG001	Endurant Bifurcated Arm	Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair

Units	Counts
Participants

Primary

Primary Effectiveness Endpoint (Technical Success)

Technical success defined as successful delivery and deployment of the stent graft in the planned location and with no unintentional coverage of both the internal iliac arteries or any visceral aortic branches and with removal of the system. Technical success was assessed intra-operatively.

The Technical Success of the Endurant Bifurcated arm was based on obtaining information for the first 121 evaluable subjects available in the clinical study.

Posted

Number

participants

Intra-operatively

ID	Title	Description
OG000	Endurant AUI Arm	Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
OG001	Endurant Bifurcated Arm	Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair

Units	Counts
Participants	OG000

Primary

Primary Effectiveness Endpoint (Treatment Success)

Treatment success is defined as Technical success and the following:

Freedom from AAA diameter increased, defined as >5 mm increase in maximum diameter as measured on CT scan (or MRA/MRI) at 12 months as compared to 1 month
Freedom from Types I and III endoleaks at 12 months including those requiring intervention through 12 months
Freedom from aneurysm rupture through 12 months
Freedom from conversion to surgery through 12 months
Freedom from stent graft migrations resulting in a serious adverse event or requiring secondary intervention through 12 months
Freedom from stent graft occlusion at 12 months

The number of evaluable subjects for ths endpoint.

Posted

Number

participants

12 months

ID	Title	Description
OG000	Endurant AUI Arm	Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
OG001	Endurant Bifurcated Arm	Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair

Units	Counts
Participants

Secondary

Secondary Endpoint - Effectiveness Evaluation

The following secondary endpoints were included in the pivotal trial to evaluate the effectiveness profile of the Endurant Stent Graft System.

Stent Graft migration through 12 months
Stent Graft Patency through 12 months
All stent Graft Endoleaks at 1-month, 6-months, and 12-month
Secondary Procedures to correct Type I and type III Endoleaks through 12 months
Secondary Endovascular Procedures through 12 months
Technical Observations through 12 months

Number of subjects enrolled in the study arm

Posted

Number

percentage of evaluable subjects

12 months

ID	Title	Description
OG000	Endurant AUI Arm	Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
OG001	Endurant Bifurcated Arm	Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected44 at risk EG0011 events1 affected150 at risk
Other Bleeding Complications	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0011 events1 affected150 at risk
Bradycardia	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected44 at risk EG0013 events3 affected150 at risk
Cardiac Arrest	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected44 at risk EG0011 events1 affected150 at risk
Cardiopulmonary Failure	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected44 at risk EG0010 events0 affected150 at risk
Chest Pain	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0011 events1 affected150 at risk
Congestive Heart Failure	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0013 events3 affected150 at risk
Myocardial Infarction	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected44 at risk EG0012 events2 affected150 at risk
New Arrhythmia	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected44 at risk EG0013 events3 affected150 at risk
Other Cardiac Complications	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected44 at risk EG0012 events2 affected150 at risk
Bowel Necrosis	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0011 events1 affected150 at risk
Bowel Obstruction	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected44 at risk EG0010 events0 affected150 at risk
Diverticulitis	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0011 events1 affected150 at risk
Gastrointestinal Bleeding	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0012 events2 affected150 at risk
Intestinal Polyps	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected44 at risk EG0010 events0 affected150 at risk
Nausea	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0011 events1 affected150 at risk
Other Bleeding Complications	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0011 events1 affected150 at risk
Other Bowel Complications	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0004 events4 affected44 at risk EG0014 events4 affected150 at risk
Other Complications	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected44 at risk EG0011 events1 affected150 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected44 at risk EG0010 events0 affected150 at risk
Chest Pain	General disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0011 events1 affected150 at risk
Chest Pain, Non-Cardiac	General disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0011 events1 affected150 at risk
Death, Cause Unknown	General disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected44 at risk EG0010 events0 affected150 at risk
Endoleak Type IIa (single patent collateral vessel)	General disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0011 events1 affected150 at risk
Endoleak Type IIb (multiple patent collateral vessels)	General disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0011 events1 affected150 at risk
Endoleak Type Ib (Distal end)	General disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0011 events1 affected150 at risk
Fever	General disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0019 events9 affected150 at risk
Multi-Organ Failure	General disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0011 events1 affected150 at risk
Other Complications	General disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0018 events8 affected150 at risk
Other Vascular Complications	General disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected44 at risk EG0011 events1 affected150 at risk
Stenosis	General disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected44 at risk EG0011 events1 affected150 at risk
Other Complications	Hepatobiliary disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected44 at risk EG0010 events0 affected150 at risk
Other Bowel Complications	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0011 events1 affected150 at risk
Other Complications	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0011 events1 affected150 at risk
Other Renal Complications	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0011 events1 affected150 at risk
Sepsis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected44 at risk EG0012 events2 affected150 at risk
Septic Shock	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected44 at risk EG0011 events1 affected150 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected44 at risk EG0012 events2 affected150 at risk
Wound Infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected44 at risk EG0011 events1 affected150 at risk
Bleeding > 1000 cc, procedural	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected44 at risk EG0012 events2 affected150 at risk
Other Bleeding Complications	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected44 at risk EG0010 events0 affected150 at risk
Other Complications	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected44 at risk EG0011 events1 affected150 at risk
Other Renal Complications	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected44 at risk EG0010 events0 affected150 at risk
Other Vascular Complications	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected44 at risk EG0012 events2 affected150 at risk
Increased Creatinine	Investigations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0013 events3 affected150 at risk
Other Bowel Complications	Investigations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0011 events1 affected150 at risk
Other Complications	Investigations	MedDRA 16.0	Systematic Assessment	EG0002 events1 affected44 at risk EG0011 events1 affected150 at risk
Hyperkalemia	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected44 at risk EG0010 events0 affected150 at risk
Other Complications	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0003 events3 affected44 at risk EG0015 events5 affected150 at risk
Other Pulmonary Complication	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected44 at risk EG0010 events0 affected150 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0011 events1 affected150 at risk
Other Orthopedic Complications	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0011 events1 affected150 at risk
Other Vascular Complications	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected44 at risk EG0010 events0 affected150 at risk
Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected44 at risk EG0012 events2 affected150 at risk
Lung Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected44 at risk EG0013 events3 affected150 at risk
Other Bowel Complications	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected44 at risk EG0010 events0 affected150 at risk
Other Renal Complications	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0011 events1 affected150 at risk
Cerebrovascular Accident (CVA) - Stroke	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0003 events3 affected44 at risk EG0015 events3 affected150 at risk
Intra-Cranial/Cerebral Hemorrhage	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0011 events1 affected150 at risk
Other Complications	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0012 events2 affected150 at risk
Other Neurological Complications	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected44 at risk EG0011 events1 affected150 at risk
Seizure	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected44 at risk EG0010 events0 affected150 at risk
Change In Mental Status	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0013 events2 affected150 at risk
Other Neurological Complications	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected44 at risk EG0010 events0 affected150 at risk
Hematuria	Renal and urinary disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected44 at risk EG0011 events1 affected150 at risk
Other Renal Complications	Renal and urinary disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected44 at risk EG0012 events2 affected150 at risk
Other Urologic Complications	Renal and urinary disorders	MedDRA 16.0	Systematic Assessment	EG0003 events1 affected44 at risk EG0012 events2 affected150 at risk
Renal Artery Stenosis	Renal and urinary disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0011 events1 affected150 at risk
Renal Failure	Renal and urinary disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected44 at risk EG0012 events2 affected150 at risk
Urinary Retention	Renal and urinary disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0013 events3 affected150 at risk
Other Vascular Complications	Reproductive system and breast disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0011 events1 affected150 at risk
Acute Respiratory Distress Syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0011 events1 affected150 at risk
COPD	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected44 at risk EG0011 events1 affected150 at risk
Other Bleeding Complications	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected44 at risk EG0010 events0 affected150 at risk
Other Complications	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected44 at risk EG0010 events0 affected150 at risk
Other Pulmonary Complication	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0005 events4 affected44 at risk EG0012 events2 affected150 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0011 events1 affected150 at risk
Pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0014 events4 affected150 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0011 events1 affected150 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0011 events1 affected150 at risk
Respiratory Depression or Failure	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0005 events5 affected44 at risk EG0014 events3 affected150 at risk
Shortness Of Breath	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected44 at risk EG0011 events1 affected150 at risk
Aneurysm Rupture	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0011 events1 affected150 at risk
Embolism (non-pulmonary)	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0011 events1 affected150 at risk
Hematoma	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0011 events1 affected150 at risk
Hypertension	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0011 events1 affected150 at risk
Hypotension	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0013 events3 affected150 at risk
Other Cardiac Complications	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0011 events1 affected150 at risk
Other Vascular Complications	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected44 at risk EG0013 events3 affected150 at risk
Peripheral Ischemia	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0011 events1 affected150 at risk
Pseudoaneurysm	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected44 at risk EG0010 events0 affected150 at risk
Venous Insufficiency	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0011 events1 affected150 at risk
Vessel Rupture/Dissection (femoral, iliac, etc.)	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected44 at risk EG0011 events1 affected150 at risk
Anemia	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0011 events1 affected150 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG0005 events5 affected44 at risk EG0010 events0 affected150 at risk
New Arrhythmia	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG00110 events8 affected150 at risk
Other Cardiac Complications	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0003 events3 affected44 at risk EG0010 events0 affected150 at risk
Constipation	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG00116 events16 affected150 at risk
Other Bowel Complications	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG00112 events11 affected150 at risk
Fever	General disorders	MedDRA 16.0	Systematic Assessment	EG0007 events7 affected44 at risk EG00121 events21 affected150 at risk
Other Complications	General disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0018 events8 affected150 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0018 events8 affected150 at risk
Wound Infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0003 events3 affected44 at risk EG0010 events0 affected150 at risk
Other Wound Complications	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0004 events4 affected44 at risk EG0010 events0 affected150 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG00120 events19 affected150 at risk
Low HCT/Low HGB	Investigations	MedDRA 16.0	Systematic Assessment	EG0003 events3 affected44 at risk EG0010 events0 affected150 at risk
Other Complications	Investigations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected44 at risk EG0019 events9 affected150 at risk
Other Complications	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG00011 events9 affected44 at risk EG00111 events9 affected150 at risk
Other Renal Complications	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0004 events4 affected44 at risk EG0010 events0 affected150 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0003 events3 affected44 at risk EG00110 events10 affected150 at risk
Other Complications	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0005 events4 affected44 at risk EG0010 events0 affected150 at risk
Other Complications	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0006 events6 affected44 at risk EG0010 events0 affected150 at risk
Other Neurological Complications	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0008 events6 affected44 at risk EG00112 events11 affected150 at risk
Other Complications	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0005 events5 affected44 at risk EG0010 events0 affected150 at risk
Renal Insufficiency	Renal and urinary disorders	MedDRA 16.0	Systematic Assessment	EG0005 events5 affected44 at risk EG0010 events0 affected150 at risk
Urinary Retention	Renal and urinary disorders	MedDRA 16.0	Systematic Assessment	EG0003 events3 affected44 at risk EG0010 events0 affected150 at risk
Other Pulmonary Complication	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0005 events3 affected44 at risk EG0010 events0 affected150 at risk
Other Complications	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG0008 events8 affected44 at risk EG0019 events9 affected150 at risk
Hematoma	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0005 events5 affected44 at risk EG0010 events0 affected150 at risk
Hypertension	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0005 events5 affected44 at risk EG0019 events9 affected150 at risk

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	1. Endurant AUI Arm	Endurant Stent Graft System - Endurant AUI arm			25	44	35	44
EG001	2. Endurant Bifurcated Arm	Endurant Stent Graft System - Endurant Bifurcated arm			64	150	80	150

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

ID	Title	Description
BG000	Endurant AUI Arm	Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
BG001	Endurant Bifurcated Arm	Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
BG002	Total	Total of all reporting groups