Zenith® Low Profile AAA Endovascular Graft | NCT02535065

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Endovascular Graft	Experimental	The Zenith Low Profile AAA Endovascular Graft and ancillary components	Device: Zenith Low Profile AAA Endovascular Graft and ancillary components

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Zenith Low Profile AAA Endovascular Graft and ancillary components	Device	Treatment of patients with abdominal aortic, aortoiliac, or iliac aneurysms having morphology suitable for endovascular repair

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Patients Without Major Adverse Events Within 30 Days	Major adverse events include all-cause death, Q-wave MI, renal failure requiring dialysis, paralysis, stroke, bowel ischemia, re-intubation	30 days
Number of Patients With Device Success	Device success will be measured with none of the following: type I or III endoleaks requiring re-intervention, graft limb occlusion, aneurysm rupture or conversion to open surgical repair, aneurysm enlargement greater than 0.5 cm	12 months

Eligibility Module

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University Medical Center		Stanford	California	94305	United States
University of Colorado

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Endovascular Graft	The Zenith Low Profile AAA Endovascular Graft and ancillary components Zenith Low Profile AAA Endovascular Graft and ancillary components: Treatment of patients with abdominal aortic, aortoiliac, or iliac aneurysms having morphology suitable for endovascular repair

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan: version 6	Nov 6, 2013

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Arm/Group Information

ID	Title	Description
BG000	Endovascular Graft	The Zenith Low Profile AAA Endovascular Graft and ancillary components Zenith Low Profile AAA Endovascular Graft and ancillary components: Treatment of patients with abdominal aortic, aortoiliac, or iliac aneurysms having morphology suitable for endovascular repair

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00070.5± 8.9

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0004
Male	BG00058

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000
Asian	BG0000

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00062

Diabetes

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Yes	BG00015
No	BG00047

Smoking Status

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Current	BG00016
Past	BG00040

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

Number of Patients Without Major Adverse Events Within 30 Days

Major adverse events include all-cause death, Q-wave MI, renal failure requiring dialysis, paralysis, stroke, bowel ischemia, re-intubation

Posted

Count of Participants

Participants

30 days

ID	Title	Description
OG000	Endovascular Graft	The Zenith Low Profile AAA Endovascular Graft and ancillary components Zenith Low Profile AAA Endovascular Graft and ancillary components: Treatment of patients with abdominal aortic, aortoiliac, or iliac aneurysms having morphology suitable for endovascular repair

Units	Counts
Participants	OG00062

Title

Denominators

Categories

Title	Measurements
	OG00062

Primary

Number of Patients With Device Success

Device success will be measured with none of the following: type I or III endoleaks requiring re-intervention, graft limb occlusion, aneurysm rupture or conversion to open surgical repair, aneurysm enlargement greater than 0.5 cm

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	Endovascular Graft	The Zenith Low Profile AAA Endovascular Graft and ancillary components Zenith Low Profile AAA Endovascular Graft and ancillary components: Treatment of patients with abdominal aortic, aortoiliac, or iliac aneurysms having morphology suitable for endovascular repair

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Endovascular Graft	The Zenith Low Profile AAA Endovascular Graft and ancillary components Zenith Low Profile AAA Endovascular Graft and ancillary components: Treatment of patients with abdominal aortic, aortoiliac, or iliac aneurysms having morphology suitable for endovascular repair	13	62	49	62	7	62

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina unstable	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk
Arrhythmia	Cardiac disorders	MedDRA	Systematic Assessment	EG00011 events6 affected62 at risk
Bradycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk
Cardiac arrest	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 events2 affected62 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA	Systematic Assessment	EG0004 events3 affected62 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk
Myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0005 events3 affected62 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA	Systematic Assessment	EG0005 events5 affected62 at risk
Vertigo	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk
Gastritis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 events2 affected62 at risk
Ileus	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected62 at risk
Chest pain	General disorders	MedDRA	Systematic Assessment	EG0002 events2 affected62 at risk
Stent-graft endoleak	General disorders	MedDRA	Systematic Assessment	EG0005 events5 affected62 at risk
Vascular stent occlusion	General disorders	MedDRA	Systematic Assessment	EG0006 events5 affected62 at risk
Vascular stent stenosis	General disorders	MedDRA	Systematic Assessment	EG0002 events2 affected62 at risk
Vascular stent thrombosis	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk
Vessel puncture site haematoma	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0002 events2 affected62 at risk
Contrast media reaction	Immune system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk
Bursitis infective	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk
Diverticulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk
Gastrointestinal infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk
Influenza	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG00010 events9 affected62 at risk
Sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected62 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected62 at risk
Endotracheal intubation complication	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk
Fall	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk
Blood glucose increased	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 events2 affected62 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0004 events3 affected62 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk
Gastrointestinal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk
Cerebral small vessel ischaemic disease	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 events2 affected62 at risk
Haemorrhagic cerebellar infarction	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk
Seizure	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 events2 affected62 at risk
Syncope	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk
Device kink	Product Issues	MedDRA	Systematic Assessment	EG0002 events2 affected62 at risk
Anxiety	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk
Depression	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk
Mental status changes	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0002 events2 affected62 at risk
Haematuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk
Urinary retention	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0003 events2 affected62 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0007 events7 affected62 at risk
Chronic respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected62 at risk
Hip arthroplasty	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0002 events1 affected62 at risk
Ileostomy closure	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk
Knee arthroplasty	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk
Mechanical ventilation	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0002 events2 affected62 at risk
Aortic aneurysm	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk
Hypotension	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk
Iliac artery stenosis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk
Peripheral artery aneurysm	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk
Peripheral artery occlusion	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected62 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Arrhythmia	Cardiac disorders	MedDRA	Systematic Assessment		EG0004 events4 affected62 at risk
Stent-graft endoleak	General disorders	MedDRA	Systematic Assessment		EG0005 events4 affected62 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