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Trial record 1 of 14 for:    ENGAGE PAS
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Endurant Stent Graft System Post Approval Study (ENGAGE PAS)

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ClinicalTrials.gov Identifier: NCT01379222
Recruitment Status : Completed
First Posted : June 23, 2011
Results First Posted : February 4, 2019
Last Update Posted : February 4, 2019
Sponsor:
Collaborator:
Duke Clinical Research Institute
Information provided by (Responsible Party):
Medtronic Endovascular

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Aortic Aneurysm, Abdominal
Intervention Device: Endurant Stent Graft System
Enrollment 178
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ENGAGE PAS De Novo Subjects
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 178
Completed 105
Not Completed 73
Arm/Group Title ENGAGE PAS De Novo Subjects
Hide Arm/Group Description

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 Number of Baseline Participants 178
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 178 participants
71.7  (8.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 178 participants
Female
32
  18.0%
Male
146
  82.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 178 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   1.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
7
   3.9%
White
169
  94.9%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 178 participants
178
 100.0%
1.Primary Outcome
Title Freedom From Aneurysm-related Mortality Rate (ARM) at 5 Years (1826 Days)
Hide Description

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.

Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ENGAGE PAS De Novo Subjects
Hide Arm/Group Description:

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 Number of Participants Analyzed 178
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of Surviving
0.989
(0.973 to 1.000)
Time Frame 5 Years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1. Engage PAS
Hide Arm/Group Description Medtronic Engage PAS De Novo Subjects
All-Cause Mortality
1. Engage PAS
Affected / at Risk (%)
Total   48/178 (26.97%)    
Show Serious Adverse Events Hide Serious Adverse Events
1. Engage PAS
Affected / at Risk (%) # Events
Total   86/178 (48.31%)    
Blood and lymphatic system disorders   
Anaemia  1  4/178 (2.25%)  5
Coagulopathy  1  2/178 (1.12%)  2
Hypercoagulation  1  1/178 (0.56%)  1
Leukocytosis  1  1/178 (0.56%)  1
Red Blood Cell Abnormality  1  3/178 (1.69%)  3
Thrombocytopenia  1  3/178 (1.69%)  3
Cardiac disorders   
Arrhythmia  1  5/178 (2.81%)  5
Atrial Fibrillation  1  2/178 (1.12%)  2
Cardiac Arrest  1  7/178 (3.93%)  7
Cardiac Failure Congestive  1  5/178 (2.81%)  6
Cardio-Respiratory Arrest  1  1/178 (0.56%)  1
Cardiogenic Shock  1  1/178 (0.56%)  1
Cardiomyopathy  1  3/178 (1.69%)  3
Cardiopulmonary Failure  1  3/178 (1.69%)  4
Cardiovascular Disorder  1  1/178 (0.56%)  1
Coronary Artery Disease  1  1/178 (0.56%)  1
Myocardial Infarction  1  15/178 (8.43%)  16
Ventricular Tachycardia  1  1/178 (0.56%)  1
Gastrointestinal disorders   
Diarrhoea  1  1/178 (0.56%)  1
Gastrointestinal Necrosis  1  1/178 (0.56%)  1
Intestinal Ischaemia  1  2/178 (1.12%)  2
Lower Gastrointestinal Haemorrhage  1  1/178 (0.56%)  1
Retroperitoneal Haemorrhage  1  1/178 (0.56%)  1
General disorders   
Asthenia  1  1/178 (0.56%)  1
Chest Pain  1  1/178 (0.56%)  1
Death  1  3/178 (1.69%)  3
Generalised Oedema  1  1/178 (0.56%)  1
Multi-Organ Failure  1  2/178 (1.12%)  2
Pyrexia  1  5/178 (2.81%)  5
Stent-Graft Endoleak  1  6/178 (3.37%)  6
Thrombosis In Device  1  2/178 (1.12%)  2
Unevaluable Event  1  3/178 (1.69%)  3
Infections and infestations   
Cellulitis  1  1/178 (0.56%)  1
Pneumonia  1  1/178 (0.56%)  1
Sepsis  1  4/178 (2.25%)  5
Urinary Tract Infection  1  4/178 (2.25%)  5
Injury, poisoning and procedural complications   
Toxicity To Various Agents  1  1/178 (0.56%)  2
Vascular Graft Occlusion  1  3/178 (1.69%)  4
Investigations   
Blood Creatinine Increased  1  1/178 (0.56%)  1
Musculoskeletal and connective tissue disorders   
Pain In Extremity  1  1/178 (0.56%)  2
Spinal Osteoarthritis  1  1/178 (0.56%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Lung Neoplasm Malignant  1  2/178 (1.12%)  2
Myelodysplastic Syndrome  1  1/178 (0.56%)  1
Neoplasm  1  1/178 (0.56%)  1
Neoplasm Malignant  1  6/178 (3.37%)  6
Prostate Cancer  1  1/178 (0.56%)  1
Nervous system disorders   
Balance Disorder  1  1/178 (0.56%)  1
Cerebral Haemorrhage  1  1/178 (0.56%)  1
Cerebrovascular Accident  1  7/178 (3.93%)  7
Dementia  1  1/178 (0.56%)  1
Hepatic Encephalopathy  1  1/178 (0.56%)  1
Metabolic Encephalopathy  1  1/178 (0.56%)  1
Transient Ischaemic Attack  1  1/178 (0.56%)  1
Psychiatric disorders   
Agitation  1  1/178 (0.56%)  1
Mental Status Changes  1  2/178 (1.12%)  2
Renal and urinary disorders   
Renal Artery Occlusion  1  1/178 (0.56%)  1
Renal Artery Stenosis  1  1/178 (0.56%)  1
Renal Failure  1  10/178 (5.62%)  11
Renal Failure Acute  1  1/178 (0.56%)  1
Renal Infarct  1  2/178 (1.12%)  2
Renal Tubular Necrosis  1  1/178 (0.56%)  1
Reproductive system and breast disorders   
Scrotal Oedema  1  1/178 (0.56%)  1
Respiratory, thoracic and mediastinal disorders   
Acute Respiratory Distress Syndrome  1  1/178 (0.56%)  1
Chronic Obstructive Pulmonary Disease  1  2/178 (1.12%)  2
Pleural Effusion  1  2/178 (1.12%)  2
Pulmonary Oedema  1  2/178 (1.12%)  2
Respiratory Arrest  1  1/178 (0.56%)  1
Respiratory Failure  1  16/178 (8.99%)  18
Tracheal Mass  1  1/178 (0.56%)  1
Vascular disorders   
Aortic Dissection  1  1/178 (0.56%)  1
Arterial Haemorrhage  1  1/178 (0.56%)  1
Arterial Occlusive Disease  1  2/178 (1.12%)  2
Deep Vein Thrombosis  1  1/178 (0.56%)  1
Haematoma  1  3/178 (1.69%)  3
Hypotension  1  4/178 (2.25%)  4
Intermittent Claudication  1  1/178 (0.56%)  1
Peripheral Ischaemia  1  1/178 (0.56%)  1
Shock Haemorrhagic  1  2/178 (1.12%)  2
Thrombosis  1  2/178 (1.12%)  2
1
Term from vocabulary, MedDRA 10.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
1. Engage PAS
Affected / at Risk (%) # Events
Total   15/178 (8.43%)    
General disorders   
Pyrexia  1  15/178 (8.43%)  15
1
Term from vocabulary, MedDRA 10.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Thushari Alahapperuma
Organization: Medtronic
Phone: 763.526.8119
EMail: thushari.r.alahapperuma@medtronic.com
Layout table for additonal information
Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01379222     History of Changes
Other Study ID Numbers: 10012289
First Submitted: June 21, 2011
First Posted: June 23, 2011
Results First Submitted: December 19, 2018
Results First Posted: February 4, 2019
Last Update Posted: February 4, 2019