Endurant Stent Graft System Post Approval Study (ENGAGE PAS)

• Sponsor: Medtronic Cardiovascular (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01379222
• Collaborator: Duke Clinical Research Institute (Other)
• Enrollment: 178
• Locations: 24
• Arm: 1
• Duration (Months): 76
• Patients Per Site: 7.4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of the study is to demonstrate the long term safety and effectiveness of the Endurant Stent Graft System for the endovascular treatment of infrarenal abdominal aortic aneurysms in a post-approval environment, through the endpoints established in this protocol.

The clinical objective of the study is to evaluate the long term safety and effectiveness of the Endurant Stent Graft System assessed at 5 years through freedom from Aneurysm-Related Mortality (ARM).

Condition or Disease	Intervention/Treatment	Phase
Aortic Aneurysm, Abdominal	Device: Endurant Stent Graft System	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 178 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Post Approval Study Evaluating the Long Term Safety and Effectiveness of the Endurant Stent Graft System (ENGAGE PAS)
• Study Start Date: Aug 1, 2011
• Actual Primary Completion Date: Dec 1, 2017
• Actual Study Completion Date: Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	Device: 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.

Outcome Measures

Primary Outcome Measures

1. Freedom From Aneurysm-related Mortality Rate (ARM) at 5 Years (1826 Days) [5 years]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age ≥18 years

• Indication for elective surgical repair of abdominal aortic aneurysm (AAA) with an endovascular stent graft in accordance with the applicable guidelines on endovascular interventions and the Instructions for Use of the Endurant Stent Graft System

• Signed consent form. The subject or legal representative has been informed of the nature of the trial and has consented to participate and authorized the collection and release of his medical information

• Intention to electively implant the Endurant Stent Graft System

• Ability and willingness to comply with the Clinical Investigational Plan (CIP).

Exclusion Criteria:

• High probability of non-adherence to physician's follow-up requirements

• Current participation in a concurrent trial which may confound study results

• Female of childbearing potential in whom pregnancy cannot be excluded or who is lactating.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ronald Reagan UCLA Medical Center	Los Angeles	California	United States	90095
2	Stanford Hospital & Clinics	Stanford	California	United States	94305-5330
3	Yale New Haven Hospital	New Haven	Connecticut	United States	06510-3220
4	Bayfront Medical Center	Saint Petersburg	Florida	United States	33701-4814
5	Medical Center of Central Georgia (MCCG)	Macon	Georgia	United States	31201-2102
6	Mercy Hospital and Medical Center	Chicago	Illinois	United States	60616-2332
7	Southern Illinois University School of Medicine	Springfield	Illinois	United States	62702-4933
8	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215-5324
9	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756-1000
10	Morristown Memorial Hospital	Morristown	New Jersey	United States	07960-6136
11	WakeMed Health & Hospitals	Raleigh	North Carolina	United States	27610-1231
12	Novant Health Forsyth Medical Center	Winston-Salem	North Carolina	United States	27103-3013
13	Sanford Medical Center Fargo	Fargo	North Dakota	United States	58122
14	The Christ Hospital	Cincinnati	Ohio	United States	45219-2906
15	University Hospitals Cleveland Medical Center	Cleveland	Ohio	United States	44106-1716
16	Lehigh Valley Hospital - Cedar Crest	Allentown	Pennsylvania	United States	18103
17	University of Pittsburgh Medical Center UPMC Shadyside	Pittsburgh	Pennsylvania	United States	15232-1311
18	Physicians Regional Medical Center	Knoxville	Tennessee	United States	37917-4556
19	Parkwest Medical Center	Knoxville	Tennessee	United States	37923-4325
20	Baylor Jack and Jane Hamilton Heart and Vascular Hospital	Dallas	Texas	United States	75226-1316
21	CHI Saint Luke's Health - Baylor Saint Luke's Medical Center	Houston	Texas	United States	77030-2604
22	University of Virginia Medical Center	Charlottesville	Virginia	United States	22908-0816
23	Inova Fairfax Hospital	Falls Church	Virginia	United States	22042-3307
24	Aurora Saint Luke's Medical Center	Milwaukee	Wisconsin	United States	53215-3669

Sponsors and Collaborators

• Medtronic Cardiovascular
• Duke Clinical Research Institute

Investigators

• Principal Investigator: Marc Schermerhorn, MD, Beth Israel Deaconess Medical Center

Study Documents (Full-Text)

• Study Protocol - Jun 11, 2013
• Statistical Analysis Plan - Jul 8, 2011

More Information

Publications

None provided.

• Responsible Party: Medtronic Cardiovascular
• ClinicalTrials.gov Identifier: NCT01379222
• Other Study ID Numbers: 10012289
• First Posted: Jun 23, 2011
• Last Update Posted: Oct 29, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Medtronic Cardiovascular: AAA; Abdominal Aortic Aneurysm; EVAR; Endovascular aneurysm repair
• Additional relevant MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal

Study Results

Participant Flow

Arm/Group Title	ENGAGE PAS De Novo Subjects
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

Baseline Characteristics

Arm/Group Title	ENGAGE PAS De Novo Subjects
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 Participants	178
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	71.7 (8.2)
Sex: Female, Male (Count of Participants)
Female	32 18%
Male	146 82%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	2 1.1%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	7 3.9%
White	169 94.9%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	178 100%

Outcome Measures

1. Primary Outcome

Title	Freedom From Aneurysm-related Mortality Rate (ARM) at 5 Years (1826 Days)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ENGAGE PAS De Novo Subjects
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.
Measure Participants	178
Number (95% Confidence Interval) [Proportion of Surviving]	0.989

Adverse Events

Time Frame	5 Years
Arm/Group Title	1. Engage PAS
Arm/Group Description	Medtronic Engage PAS De Novo Subjects
All Cause Mortality
	1. Engage PAS
	Affected / at Risk (%)	# Events
Total	48/178 (27%)
Serious Adverse Events
	1. Engage PAS
	Affected / at Risk (%)	# Events
Total	86/178 (48.3%)
Blood and lymphatic system disorders
Anaemia	4/178 (2.2%)	5
Coagulopathy	2/178 (1.1%)	2
Hypercoagulation	1/178 (0.6%)	1
Leukocytosis	1/178 (0.6%)	1
Red Blood Cell Abnormality	3/178 (1.7%)	3
Thrombocytopenia	3/178 (1.7%)	3
Cardiac disorders
Arrhythmia	5/178 (2.8%)	5
Atrial Fibrillation	2/178 (1.1%)	2
Cardiac Arrest	7/178 (3.9%)	7
Cardiac Failure Congestive	5/178 (2.8%)	6
Cardio-Respiratory Arrest	1/178 (0.6%)	1
Cardiogenic Shock	1/178 (0.6%)	1
Cardiomyopathy	3/178 (1.7%)	3
Cardiopulmonary Failure	3/178 (1.7%)	4
Cardiovascular Disorder	1/178 (0.6%)	1
Coronary Artery Disease	1/178 (0.6%)	1
Myocardial Infarction	15/178 (8.4%)	16
Ventricular Tachycardia	1/178 (0.6%)	1
Gastrointestinal disorders
Diarrhoea	1/178 (0.6%)	1
Gastrointestinal Necrosis	1/178 (0.6%)	1
Intestinal Ischaemia	2/178 (1.1%)	2
Lower Gastrointestinal Haemorrhage	1/178 (0.6%)	1
Retroperitoneal Haemorrhage	1/178 (0.6%)	1
General disorders
Asthenia	1/178 (0.6%)	1
Chest Pain	1/178 (0.6%)	1
Death	3/178 (1.7%)	3
Generalised Oedema	1/178 (0.6%)	1
Multi-Organ Failure	2/178 (1.1%)	2
Pyrexia	5/178 (2.8%)	5
Stent-Graft Endoleak	6/178 (3.4%)	6
Thrombosis In Device	2/178 (1.1%)	2
Unevaluable Event	3/178 (1.7%)	3
Infections and infestations
Cellulitis	1/178 (0.6%)	1
Pneumonia	1/178 (0.6%)	1
Sepsis	4/178 (2.2%)	5
Urinary Tract Infection	4/178 (2.2%)	5
Injury, poisoning and procedural complications
Toxicity To Various Agents	1/178 (0.6%)	2
Vascular Graft Occlusion	3/178 (1.7%)	4
Investigations
Blood Creatinine Increased	1/178 (0.6%)	1
Musculoskeletal and connective tissue disorders
Pain In Extremity	1/178 (0.6%)	2
Spinal Osteoarthritis	1/178 (0.6%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant	2/178 (1.1%)	2
Myelodysplastic Syndrome	1/178 (0.6%)	1
Neoplasm	1/178 (0.6%)	1
Neoplasm Malignant	6/178 (3.4%)	6
Prostate Cancer	1/178 (0.6%)	1
Nervous system disorders
Balance Disorder	1/178 (0.6%)	1
Cerebral Haemorrhage	1/178 (0.6%)	1
Cerebrovascular Accident	7/178 (3.9%)	7
Dementia	1/178 (0.6%)	1
Hepatic Encephalopathy	1/178 (0.6%)	1
Metabolic Encephalopathy	1/178 (0.6%)	1
Transient Ischaemic Attack	1/178 (0.6%)	1
Psychiatric disorders
Agitation	1/178 (0.6%)	1
Mental Status Changes	2/178 (1.1%)	2
Renal and urinary disorders
Renal Artery Occlusion	1/178 (0.6%)	1
Renal Artery Stenosis	1/178 (0.6%)	1
Renal Failure	10/178 (5.6%)	11
Renal Failure Acute	1/178 (0.6%)	1
Renal Infarct	2/178 (1.1%)	2
Renal Tubular Necrosis	1/178 (0.6%)	1
Reproductive system and breast disorders
Scrotal Oedema	1/178 (0.6%)	1
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome	1/178 (0.6%)	1
Chronic Obstructive Pulmonary Disease	2/178 (1.1%)	2
Pleural Effusion	2/178 (1.1%)	2
Pulmonary Oedema	2/178 (1.1%)	2
Respiratory Arrest	1/178 (0.6%)	1
Respiratory Failure	16/178 (9%)	18
Tracheal Mass	1/178 (0.6%)	1
Vascular disorders
Aortic Dissection	1/178 (0.6%)	1
Arterial Haemorrhage	1/178 (0.6%)	1
Arterial Occlusive Disease	2/178 (1.1%)	2
Deep Vein Thrombosis	1/178 (0.6%)	1
Haematoma	3/178 (1.7%)	3
Hypotension	4/178 (2.2%)	4
Intermittent Claudication	1/178 (0.6%)	1
Peripheral Ischaemia	1/178 (0.6%)	1
Shock Haemorrhagic	2/178 (1.1%)	2
Thrombosis	2/178 (1.1%)	2
Other (Not Including Serious) Adverse Events
	1. Engage PAS
	Affected / at Risk (%)	# Events
Total	15/178 (8.4%)
General disorders
Pyrexia	15/178 (8.4%)	15

Limitations/Caveats

[Not Specified]

More Information

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.