Trial Outcomes & Findings for Post-Approval Trial of the Talent™ Abdominal Stent Graft to Treat Aortic Aneurysms (NCT NCT00816062)
NCT ID: NCT00816062
Last Updated: 2021-10-29
Results Overview
ARM is defined as death from rupture of the abdominal aortic aneurysm or from any procedure intended to treat the Abdominal Aortic Aneurysm (AAA). If a death occurred within 30 days of any procedure intended to treat the AAA, then it is presumed to be aneurysm related unless there is evidence to the contrary. Deaths occurring after 30 days of any procedure intended to treat the AAA that are procedure-related should also be aneurysm related. All deaths were adjudicated by a Clinical Events Committee (CEC) to determine aneurysm, device and/or procedure relatedness.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
94 participants
Primary outcome timeframe
5 year Kaplan Meier (KM)
Results posted on
2021-10-29
Participant Flow
166 subjects were enrolled in the previous cohort study (NCT # is not available). 94 subjects were enrolled into the Vitality study. When these two cohorts are combined it totals 260. The Vitality study collected information on its 94 enrolled subjects, but for study analysis both cohorts were combined.
Participant milestones
| Measure |
Talent Abdominal Stent Graft
Patients diagnosed with an abdominal aortic or aorto-iliac aneurysm that are considered candidates for endovascular repair, per the Food and Drug Administration (FDA) approved Instructions for Use (IFU).
\>
\> Talent Abdominal Stent Graft: The Talent Abdominal Stent Graft is indicated for the endovascular treatment of abdominal aortic aneurysms with or without iliac involvement.
|
|---|---|
|
Overall Study
STARTED
|
260
|
|
Overall Study
COMPLETED
|
133
|
|
Overall Study
NOT COMPLETED
|
127
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Post-Approval Trial of the Talent™ Abdominal Stent Graft to Treat Aortic Aneurysms
Baseline characteristics by cohort
| Measure |
Treatment
n=260 Participants
Patients diagnosed with an abdominal aortic or aorto-iliac aneurysm that are considered candidates for endovascular repair, per the FDA approved IFU.\>
\> Talent Abdominal Stent Graft: The Talent Abdominal Stent Graft is indicated for the endovascular treatment of abdominal aortic aneurysms with or without iliac involvement.
|
|---|---|
|
Age, Continuous
|
73.7 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
227 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
254 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
241 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
260 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 year Kaplan Meier (KM)Population: All enrolled subjects.
ARM is defined as death from rupture of the abdominal aortic aneurysm or from any procedure intended to treat the Abdominal Aortic Aneurysm (AAA). If a death occurred within 30 days of any procedure intended to treat the AAA, then it is presumed to be aneurysm related unless there is evidence to the contrary. Deaths occurring after 30 days of any procedure intended to treat the AAA that are procedure-related should also be aneurysm related. All deaths were adjudicated by a Clinical Events Committee (CEC) to determine aneurysm, device and/or procedure relatedness.
Outcome measures
| Measure |
Treatment
n=260 Participants
Patients diagnosed with an abdominal aortic or aorto-iliac aneurysm that are considered candidates for endovascular repair, per the FDA approved IFU.\>
\> Talent Abdominal Stent Graft: The Talent Abdominal Stent Graft is indicated for the endovascular treatment of abdominal aortic aneurysms with or without iliac involvement.
|
|---|---|
|
Freedom From Aneurysm-related Mortality (ARM)
|
.97 Proportion of participants
Interval 0.946 to 0.994
|
Adverse Events
1. Vitality
Serious events: 31 serious events
Other events: 5 other events
Deaths: 0 deaths
2. ELPS
Serious events: 99 serious events
Other events: 112 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1. Vitality
n=94 participants at risk
Medtronic Vitality
|
2. ELPS
n=166 participants at risk
Medtronic ELPS
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
1.1%
1/94 • Number of events 1 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Renal Infarct
|
0.00%
0/94 • 12 months
|
1.2%
2/166 • Number of events 2 • 12 months
|
|
Renal and urinary disorders
Renal Ischaemia
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 2 • 12 months
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Urinary Retention
|
1.1%
1/94 • Number of events 1 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Reproductive system and breast disorders
Genital Pain
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Reproductive system and breast disorders
Pelvic Fluid Collection
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
1.1%
1/94 • Number of events 1 • 12 months
|
0.00%
0/166 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
2.1%
2/94 • Number of events 2 • 12 months
|
0.00%
0/166 • 12 months
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/94 • 12 months
|
1.2%
2/166 • Number of events 2 • 12 months
|
|
Surgical and medical procedures
Cardiac Pacemaker Insertion
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Peripheral Artery Bypass
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/94 • 12 months
|
1.2%
2/166 • Number of events 2 • 12 months
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Nervous system disorders
Syncope
|
1.1%
1/94 • Number of events 1 • 12 months
|
0.00%
0/166 • 12 months
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Psychiatric disorders
Agitation
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Psychiatric disorders
Delirium Tremens
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Psychiatric disorders
Libido Decreased
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/94 • 12 months
|
1.8%
3/166 • Number of events 3 • 12 months
|
|
Renal and urinary disorders
Renal Artery Occlusion
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Renal Disorder
|
0.00%
0/94 • 12 months
|
2.4%
4/166 • Number of events 5 • 12 months
|
|
Renal and urinary disorders
Renal Failure
|
3.2%
3/94 • Number of events 3 • 12 months
|
2.4%
4/166 • Number of events 4 • 12 months
|
|
Renal and urinary disorders
Renal Failure Chronic
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Blood and lymphatic system disorders
Anaemia
|
3.2%
3/94 • Number of events 3 • 12 months
|
1.8%
3/166 • Number of events 3 • 12 months
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Blood and lymphatic system disorders
Heparin-Induced Thrombocytopenia
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 2 • 12 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Cardiac disorders
Angina Pectoris
|
1.1%
1/94 • Number of events 1 • 12 months
|
0.00%
0/166 • 12 months
|
|
Cardiac disorders
Arrhythmia
|
3.2%
3/94 • Number of events 4 • 12 months
|
3.6%
6/166 • Number of events 6 • 12 months
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/94 • 12 months
|
1.2%
2/166 • Number of events 2 • 12 months
|
|
Cardiac disorders
Bradycardia
|
1.1%
1/94 • Number of events 1 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Cardiac disorders
Cardiac Failure Congestive
|
4.3%
4/94 • Number of events 4 • 12 months
|
2.4%
4/166 • Number of events 4 • 12 months
|
|
Cardiac disorders
Cardiac Valve Disease
|
0.00%
0/94 • 12 months
|
1.2%
2/166 • Number of events 3 • 12 months
|
|
Cardiac disorders
Cardiovascular Disorder
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/94 • 12 months
|
1.8%
3/166 • Number of events 3 • 12 months
|
|
Cardiac disorders
Mitral Valve Incompetence
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Cardiac disorders
Myocardial Infarction
|
3.2%
3/94 • Number of events 3 • 12 months
|
1.8%
3/166 • Number of events 4 • 12 months
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Duodenal Ulcer Perforation
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 2 • 12 months
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Intestinal Ischaemia
|
2.1%
2/94 • Number of events 2 • 12 months
|
0.00%
0/166 • 12 months
|
|
Gastrointestinal disorders
Intestinal Mass
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
1.1%
1/94 • Number of events 1 • 12 months
|
0.00%
0/166 • 12 months
|
|
Gastrointestinal disorders
Lower Gastrointestinal Haemorrhage
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Nausea
|
1.1%
1/94 • Number of events 1 • 12 months
|
0.00%
0/166 • 12 months
|
|
Gastrointestinal disorders
Retroperitoneal Fibrosis
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
General disorders
Catheter Site Pain
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
General disorders
Chest Pain
|
0.00%
0/94 • 12 months
|
1.8%
3/166 • Number of events 3 • 12 months
|
|
General disorders
Death
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
General disorders
Device Deployment Issue
|
0.00%
0/94 • 12 months
|
1.8%
3/166 • Number of events 3 • 12 months
|
|
General disorders
Device Dislocation
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
General disorders
Device Kink
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
General disorders
Hernia
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
General disorders
Ill-Defined Disorder
|
0.00%
0/94 • 12 months
|
2.4%
4/166 • Number of events 5 • 12 months
|
|
General disorders
Medical Device Complication
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
General disorders
Oedema Peripheral
|
0.00%
0/94 • 12 months
|
1.2%
2/166 • Number of events 2 • 12 months
|
|
General disorders
Pyrexia
|
2.1%
2/94 • Number of events 2 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
General disorders
Stent Malfunction
|
1.1%
1/94 • Number of events 1 • 12 months
|
0.00%
0/166 • 12 months
|
|
General disorders
Stent-Graft Endoleak
|
2.1%
2/94 • Number of events 2 • 12 months
|
14.5%
24/166 • Number of events 32 • 12 months
|
|
Hepatobiliary disorders
Hepatic Cyst
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Hepatobiliary disorders
Hepatic Lesion
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Infections and infestations
Candida Infection
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Infections and infestations
Groin Infection
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Infections and infestations
Incision Site Cellulitis
|
1.1%
1/94 • Number of events 1 • 12 months
|
0.00%
0/166 • 12 months
|
|
Infections and infestations
Infection
|
0.00%
0/94 • 12 months
|
1.2%
2/166 • Number of events 2 • 12 months
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Infections and infestations
Pneumonia
|
2.1%
2/94 • Number of events 2 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Renal Impairment
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Infections and infestations
Pyelonephritis
|
1.1%
1/94 • Number of events 1 • 12 months
|
0.00%
0/166 • 12 months
|
|
Infections and infestations
Sepsis
|
1.1%
1/94 • Number of events 2 • 12 months
|
0.00%
0/166 • 12 months
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/94 • 12 months
|
1.2%
2/166 • Number of events 2 • 12 months
|
|
Infections and infestations
Wound Infection
|
1.1%
1/94 • Number of events 1 • 12 months
|
0.00%
0/166 • 12 months
|
|
Injury, poisoning and procedural complications
Anaemia Postoperative
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 2 • 12 months
|
|
Injury, poisoning and procedural complications
Arterial Injury
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Extradural Haematoma
|
1.1%
1/94 • Number of events 1 • 12 months
|
0.00%
0/166 • 12 months
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Pelvic Fracture
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
1.1%
1/94 • Number of events 1 • 12 months
|
0.00%
0/166 • 12 months
|
|
Injury, poisoning and procedural complications
Procedural Haemorrhage
|
1.1%
1/94 • Number of events 1 • 12 months
|
1.8%
3/166 • Number of events 3 • 12 months
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/94 • 12 months
|
3.0%
5/166 • Number of events 5 • 12 months
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/94 • 12 months
|
1.8%
3/166 • Number of events 4 • 12 months
|
|
Investigations
Blood Glucose Increased
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Investigations
Catheterisation Cardiac
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Investigations
Haematocrit Decreased
|
0.00%
0/94 • 12 months
|
1.2%
2/166 • Number of events 2 • 12 months
|
|
Investigations
Haemoglobin Decreased
|
0.00%
0/94 • 12 months
|
1.2%
2/166 • Number of events 2 • 12 months
|
|
Investigations
Laboratory Test Abnormal
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Investigations
Popliteal Pulse Increased
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Investigations
Red Blood Cell Analysis Abnormal
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Investigations
Urine Analysis Abnormal
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Investigations
Weight Increased
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Investigations
White Blood Cell Count Increased
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/94 • 12 months
|
1.2%
2/166 • Number of events 2 • 12 months
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/94 • 12 months
|
1.8%
3/166 • Number of events 3 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Degeneration
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Tightness
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/94 • 12 months
|
1.8%
3/166 • Number of events 3 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Spinal Osteoarthritis
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
1.1%
1/94 • Number of events 1 • 12 months
|
0.00%
0/166 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal Adenoma
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Transitional Cell Carcinoma
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal Stromal Tumour
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.00%
0/94 • 12 months
|
1.2%
2/166 • Number of events 2 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Squamous Cell Carcinoma Metastatic
|
1.1%
1/94 • Number of events 1 • 12 months
|
0.00%
0/166 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Lymphoma
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
1.1%
1/94 • Number of events 1 • 12 months
|
0.00%
0/166 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Cancer
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Throat Cancer
|
1.1%
1/94 • Number of events 1 • 12 months
|
0.00%
0/166 • 12 months
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Nervous system disorders
Cerebrovascular Accident
|
1.1%
1/94 • Number of events 1 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Nervous system disorders
Dementia
|
0.00%
0/94 • 12 months
|
1.2%
2/166 • Number of events 2 • 12 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Nervous system disorders
Headache
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Renal Artery Angioplasty
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Surgery
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Ureteric Calculus Removal
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Vascular disorders
Aneurysm
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Vascular disorders
Aortic Aneurysm
|
1.1%
1/94 • Number of events 1 • 12 months
|
1.8%
3/166 • Number of events 3 • 12 months
|
|
Vascular disorders
Aortic Dissection
|
1.1%
1/94 • Number of events 1 • 12 months
|
0.00%
0/166 • 12 months
|
|
Vascular disorders
Aortic Stenosis
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Vascular disorders
Arterial Occlusive Disease
|
5.3%
5/94 • Number of events 5 • 12 months
|
0.00%
0/166 • 12 months
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/94 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Vascular disorders
Haematoma
|
0.00%
0/94 • 12 months
|
1.2%
2/166 • Number of events 2 • 12 months
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/94 • 12 months
|
6.0%
10/166 • Number of events 10 • 12 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/94 • 12 months
|
1.8%
3/166 • Number of events 3 • 12 months
|
|
Vascular disorders
Intermittent Claudication
|
0.00%
0/94 • 12 months
|
1.8%
3/166 • Number of events 3 • 12 months
|
|
Vascular disorders
Peripheral Artery Dissection
|
1.1%
1/94 • Number of events 2 • 12 months
|
0.60%
1/166 • Number of events 1 • 12 months
|
|
Vascular disorders
Thrombosis
|
1.1%
1/94 • Number of events 1 • 12 months
|
0.00%
0/166 • 12 months
|
|
Vascular disorders
Vascular Occlusion
|
1.1%
1/94 • Number of events 1 • 12 months
|
0.00%
0/166 • 12 months
|
Other adverse events
| Measure |
1. Vitality
n=94 participants at risk
Medtronic Vitality
|
2. ELPS
n=166 participants at risk
Medtronic ELPS
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/94 • 12 months
|
12.7%
21/166 • Number of events 24 • 12 months
|
|
General disorders
Ill-Defined Disorder
|
0.00%
0/94 • 12 months
|
12.0%
20/166 • Number of events 31 • 12 months
|
|
General disorders
Pyrexia
|
0.00%
0/94 • 12 months
|
12.7%
21/166 • Number of events 25 • 12 months
|
|
General disorders
Stent-Graft Endoleak
|
5.3%
5/94 • Number of events 6 • 12 months
|
40.4%
67/166 • Number of events 146 • 12 months
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/94 • 12 months
|
9.0%
15/166 • Number of events 26 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/94 • 12 months
|
5.4%
9/166 • Number of events 9 • 12 months
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/94 • 12 months
|
5.4%
9/166 • Number of events 9 • 12 months
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/94 • 12 months
|
12.0%
20/166 • Number of events 22 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor can require deletion of confidential information.The sponsor cannot require changes beyond those necessary to protect confidential information. The sponsor cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER