Trial Outcomes & Findings for Endurant Stent Graft System Post Approval Study (ENGAGE PAS) (NCT NCT01379222)
NCT ID: NCT01379222
Last Updated: 2021-10-29
Results Overview
Aneurysm-Related Mortality (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 be aneurysm related. \> All deaths will be adjudicated by a Clinical Events Committee (CEC) to determine device, procedure and/or AAA relatedness.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
178 participants
Primary outcome timeframe
5 years
Results posted on
2021-10-29
Participant Flow
Participant milestones
| Measure |
ENGAGE PAS De Novo Subjects
The Endurant Stent Graft System Bifurcated device is administered to patients diagnosed with an abdominal aortic or aortoiliac aneurysm who are considered candidates for endovascular repair, per the FDA approved Instructions For Use (IFU).
\>
\> Endurant Stent Graft System: The Endurant Stent Graft System is designed to treat infrarenal abdominal aortic aneurysms using an endovascular approach. When placed within the aneurysm, the Endurant Stent Graft is designed to provide a permanent, alternative conduit for blood flow within the patient's vasculature by excluding the aneurysmal sac from blood flow and pressure.
|
|---|---|
|
Overall Study
STARTED
|
178
|
|
Overall Study
COMPLETED
|
105
|
|
Overall Study
NOT COMPLETED
|
73
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Endurant Stent Graft System Post Approval Study (ENGAGE PAS)
Baseline characteristics by cohort
| Measure |
ENGAGE PAS De Novo Subjects
n=178 Participants
The Endurant Stent Graft System Bifurcated device is administered to patients diagnosed with an abdominal aortic or aortoiliac aneurysm who are considered candidates for endovascular repair, per the FDA approved Instructions For Use (IFU).
\>
\> Endurant Stent Graft System: The Endurant Stent Graft System is designed to treat infrarenal abdominal aortic aneurysms using an endovascular approach. When placed within the aneurysm, the Endurant Stent Graft is designed to provide a permanent, alternative conduit for blood flow within the patient's vasculature by excluding the aneurysmal sac from blood flow and pressure.
|
|---|---|
|
Age, Continuous
|
71.7 Years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
146 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 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
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
169 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
178 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 yearsAneurysm-Related Mortality (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 be aneurysm related. \> All deaths will be adjudicated by a Clinical Events Committee (CEC) to determine device, procedure and/or AAA relatedness.
Outcome measures
| Measure |
ENGAGE PAS De Novo Subjects
n=178 Participants
The Endurant Stent Graft System Bifurcated device is administered to patients diagnosed with an abdominal aortic or aortoiliac aneurysm who are considered candidates for endovascular repair, per the FDA approved Instructions For Use (IFU).
\>
\> Endurant Stent Graft System: The Endurant Stent Graft System is designed to treat infrarenal abdominal aortic aneurysms using an endovascular approach. When placed within the aneurysm, the Endurant Stent Graft is designed to provide a permanent, alternative conduit for blood flow within the patient's vasculature by excluding the aneurysmal sac from blood flow and pressure.
|
|---|---|
|
Freedom From Aneurysm-related Mortality Rate (ARM) at 5 Years (1826 Days)
|
0.989 Proportion of Surviving
Interval 0.973 to 1.0
|
Adverse Events
1. Engage PAS
Serious events: 86 serious events
Other events: 15 other events
Deaths: 48 deaths
Serious adverse events
| Measure |
1. Engage PAS
n=178 participants at risk
Medtronic Engage PAS De Novo Subjects
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.2%
4/178 • Number of events 5 • 5 Years
|
|
Blood and lymphatic system disorders
Coagulopathy
|
1.1%
2/178 • Number of events 2 • 5 Years
|
|
Blood and lymphatic system disorders
Hypercoagulation
|
0.56%
1/178 • Number of events 1 • 5 Years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.56%
1/178 • Number of events 1 • 5 Years
|
|
Blood and lymphatic system disorders
Red Blood Cell Abnormality
|
1.7%
3/178 • Number of events 3 • 5 Years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.7%
3/178 • Number of events 3 • 5 Years
|
|
Cardiac disorders
Arrhythmia
|
2.8%
5/178 • Number of events 5 • 5 Years
|
|
Cardiac disorders
Atrial Fibrillation
|
1.1%
2/178 • Number of events 2 • 5 Years
|
|
Cardiac disorders
Cardiac Arrest
|
3.9%
7/178 • Number of events 7 • 5 Years
|
|
Cardiac disorders
Cardiac Failure Congestive
|
2.8%
5/178 • Number of events 6 • 5 Years
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.56%
1/178 • Number of events 1 • 5 Years
|
|
Cardiac disorders
Cardiogenic Shock
|
0.56%
1/178 • Number of events 1 • 5 Years
|
|
Cardiac disorders
Cardiomyopathy
|
1.7%
3/178 • Number of events 3 • 5 Years
|
|
Cardiac disorders
Cardiopulmonary Failure
|
1.7%
3/178 • Number of events 4 • 5 Years
|
|
Cardiac disorders
Cardiovascular Disorder
|
0.56%
1/178 • Number of events 1 • 5 Years
|
|
Cardiac disorders
Coronary Artery Disease
|
0.56%
1/178 • Number of events 1 • 5 Years
|
|
Cardiac disorders
Myocardial Infarction
|
8.4%
15/178 • Number of events 16 • 5 Years
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.56%
1/178 • Number of events 1 • 5 Years
|
|
Gastrointestinal disorders
Diarrhoea
|
0.56%
1/178 • Number of events 1 • 5 Years
|
|
Gastrointestinal disorders
Gastrointestinal Necrosis
|
0.56%
1/178 • Number of events 1 • 5 Years
|
|
Gastrointestinal disorders
Intestinal Ischaemia
|
1.1%
2/178 • Number of events 2 • 5 Years
|
|
Gastrointestinal disorders
Lower Gastrointestinal Haemorrhage
|
0.56%
1/178 • Number of events 1 • 5 Years
|
|
Gastrointestinal disorders
Retroperitoneal Haemorrhage
|
0.56%
1/178 • Number of events 1 • 5 Years
|
|
General disorders
Asthenia
|
0.56%
1/178 • Number of events 1 • 5 Years
|
|
General disorders
Chest Pain
|
0.56%
1/178 • Number of events 1 • 5 Years
|
|
General disorders
Death
|
1.7%
3/178 • Number of events 3 • 5 Years
|
|
General disorders
Generalised Oedema
|
0.56%
1/178 • Number of events 1 • 5 Years
|
|
General disorders
Multi-Organ Failure
|
1.1%
2/178 • Number of events 2 • 5 Years
|
|
General disorders
Pyrexia
|
2.8%
5/178 • Number of events 5 • 5 Years
|
|
General disorders
Stent-Graft Endoleak
|
3.4%
6/178 • Number of events 6 • 5 Years
|
|
General disorders
Thrombosis In Device
|
1.1%
2/178 • Number of events 2 • 5 Years
|
|
General disorders
Unevaluable Event
|
1.7%
3/178 • Number of events 3 • 5 Years
|
|
Infections and infestations
Cellulitis
|
0.56%
1/178 • Number of events 1 • 5 Years
|
|
Infections and infestations
Pneumonia
|
0.56%
1/178 • Number of events 1 • 5 Years
|
|
Infections and infestations
Sepsis
|
2.2%
4/178 • Number of events 5 • 5 Years
|
|
Infections and infestations
Urinary Tract Infection
|
2.2%
4/178 • Number of events 5 • 5 Years
|
|
Injury, poisoning and procedural complications
Toxicity To Various Agents
|
0.56%
1/178 • Number of events 2 • 5 Years
|
|
Injury, poisoning and procedural complications
Vascular Graft Occlusion
|
1.7%
3/178 • Number of events 4 • 5 Years
|
|
Investigations
Blood Creatinine Increased
|
0.56%
1/178 • Number of events 1 • 5 Years
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.56%
1/178 • Number of events 2 • 5 Years
|
|
Musculoskeletal and connective tissue disorders
Spinal Osteoarthritis
|
0.56%
1/178 • Number of events 1 • 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
1.1%
2/178 • Number of events 2 • 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic Syndrome
|
0.56%
1/178 • Number of events 1 • 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.56%
1/178 • Number of events 1 • 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm Malignant
|
3.4%
6/178 • Number of events 6 • 5 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.56%
1/178 • Number of events 1 • 5 Years
|
|
Nervous system disorders
Balance Disorder
|
0.56%
1/178 • Number of events 1 • 5 Years
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.56%
1/178 • Number of events 1 • 5 Years
|
|
Nervous system disorders
Cerebrovascular Accident
|
3.9%
7/178 • Number of events 7 • 5 Years
|
|
Nervous system disorders
Dementia
|
0.56%
1/178 • Number of events 1 • 5 Years
|
|
Nervous system disorders
Hepatic Encephalopathy
|
0.56%
1/178 • Number of events 1 • 5 Years
|
|
Nervous system disorders
Metabolic Encephalopathy
|
0.56%
1/178 • Number of events 1 • 5 Years
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.56%
1/178 • Number of events 1 • 5 Years
|
|
Psychiatric disorders
Agitation
|
0.56%
1/178 • Number of events 1 • 5 Years
|
|
Psychiatric disorders
Mental Status Changes
|
1.1%
2/178 • Number of events 2 • 5 Years
|
|
Renal and urinary disorders
Renal Artery Occlusion
|
0.56%
1/178 • Number of events 1 • 5 Years
|
|
Renal and urinary disorders
Renal Artery Stenosis
|
0.56%
1/178 • Number of events 1 • 5 Years
|
|
Renal and urinary disorders
Renal Failure
|
5.6%
10/178 • Number of events 11 • 5 Years
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.56%
1/178 • Number of events 1 • 5 Years
|
|
Renal and urinary disorders
Renal Infarct
|
1.1%
2/178 • Number of events 2 • 5 Years
|
|
Renal and urinary disorders
Renal Tubular Necrosis
|
0.56%
1/178 • Number of events 1 • 5 Years
|
|
Reproductive system and breast disorders
Scrotal Oedema
|
0.56%
1/178 • Number of events 1 • 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
0.56%
1/178 • Number of events 1 • 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
1.1%
2/178 • Number of events 2 • 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
1.1%
2/178 • Number of events 2 • 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
1.1%
2/178 • Number of events 2 • 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Arrest
|
0.56%
1/178 • Number of events 1 • 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
9.0%
16/178 • Number of events 18 • 5 Years
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal Mass
|
0.56%
1/178 • Number of events 1 • 5 Years
|
|
Vascular disorders
Aortic Dissection
|
0.56%
1/178 • Number of events 1 • 5 Years
|
|
Vascular disorders
Arterial Haemorrhage
|
0.56%
1/178 • Number of events 1 • 5 Years
|
|
Vascular disorders
Arterial Occlusive Disease
|
1.1%
2/178 • Number of events 2 • 5 Years
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.56%
1/178 • Number of events 1 • 5 Years
|
|
Vascular disorders
Haematoma
|
1.7%
3/178 • Number of events 3 • 5 Years
|
|
Vascular disorders
Hypotension
|
2.2%
4/178 • Number of events 4 • 5 Years
|
|
Vascular disorders
Intermittent Claudication
|
0.56%
1/178 • Number of events 1 • 5 Years
|
|
Vascular disorders
Peripheral Ischaemia
|
0.56%
1/178 • Number of events 1 • 5 Years
|
|
Vascular disorders
Shock Haemorrhagic
|
1.1%
2/178 • Number of events 2 • 5 Years
|
|
Vascular disorders
Thrombosis
|
1.1%
2/178 • Number of events 2 • 5 Years
|
Other adverse events
| Measure |
1. Engage PAS
n=178 participants at risk
Medtronic Engage PAS De Novo Subjects
|
|---|---|
|
General disorders
Pyrexia
|
8.4%
15/178 • Number of events 15 • 5 Years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place