Trial Outcomes & Findings for Endurant Bifurcated and Aorto-Uni-Iliac (AUI) Stent Graft System (NCT NCT00705718)

Last Updated: 2021-11-03

Results Overview

The primary safety endpoint is composite defined as the proportion of subjects free from major adverse events (MAE) within 1 month (day 0 - Day 30)of implant is non-inferior to the proportion of subjects free from MAEs in the Talent Control Group. The endpoint is defined as the proportion of subjects free from occurence of a MAE within 1 month of the implantation of the Endurant Stent Graft. The major adverse events composite endpoint which will be evaluated at 1 month post implant includes the occurrence of any of the following events. * All-Cause Mortality * Bowel Ischemia * Myocardial Infarction * Paraplegia * Procedural Blood Loss \> or equal to 1000 cc * Renal Failure * Respiratory Failure * Stroke

Recruitment status

COMPLETED

Study phase

Target enrollment

194 participants

Primary outcome timeframe

30 days (Safety)

Results posted on

2021-11-03

Participant Flow

Participant milestones

Participant milestones
Measure	Endurant AUI Arm Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair	Endurant Bifurcated Arm Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
Overall Study STARTED	44	150
Overall Study 1 Month Follow up	43	149
Overall Study 6 Month Follow up	40	143
Overall Study 12 Month Follow up	37	128
Overall Study COMPLETED	37	128
Overall Study NOT COMPLETED	7	22

Reasons for withdrawal

Reasons for withdrawal
Measure	Endurant AUI Arm Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair	Endurant Bifurcated Arm Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
Overall Study Death	6	6
Overall Study Not due for Visit	0	12
Overall Study Follow up not done	1	4

Baseline Characteristics

Endurant Bifurcated and Aorto-Uni-Iliac (AUI) Stent Graft System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Endurant AUI Arm n=44 Participants Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair	Endurant Bifurcated Arm n=150 Participants Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair	Total n=194 Participants Total of all reporting groups
Age, Continuous	73.8 years STANDARD_DEVIATION 7.6 • n=5 Participants	73.1 years STANDARD_DEVIATION 8.0 • n=7 Participants	73.3 years STANDARD_DEVIATION 7.9 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	137 Participants n=7 Participants	167 Participants n=5 Participants
Region of Enrollment United States	41 participants n=5 Participants	150 participants n=7 Participants	191 participants n=5 Participants
Region of Enrollment Canada	3 participants n=5 Participants	0 participants n=7 Participants	3 participants n=5 Participants
Baseline Medical History Angina	11 participants n=5 Participants	27 participants n=7 Participants	38 participants n=5 Participants
Baseline Medical History Arrhythmia	15 participants n=5 Participants	59 participants n=7 Participants	74 participants n=5 Participants
Baseline Medical History Congestive Heart Failure	7 participants n=5 Participants	24 participants n=7 Participants	31 participants n=5 Participants
Baseline Medical History Hypertension	38 participants n=5 Participants	130 participants n=7 Participants	168 participants n=5 Participants
Baseline Medical History Myocardial Infarction	14 participants n=5 Participants	45 participants n=7 Participants	59 participants n=5 Participants
Baseline Medical History Peripheral vascular disease	33 participants n=5 Participants	34 participants n=7 Participants	67 participants n=5 Participants
Baseline Medical History Abnormal renal function	14 participants n=5 Participants	43 participants n=7 Participants	57 participants n=5 Participants
Baseline Medical History Chronic obstructive pulmonary disorder	26 participants n=5 Participants	53 participants n=7 Participants	79 participants n=5 Participants
Baseline Medical History Diabetes	11 participants n=5 Participants	40 participants n=7 Participants	51 participants n=5 Participants
Baseline Medical History Tabacco use in the last 10 years	29 participants n=5 Participants	66 participants n=7 Participants	95 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days (Safety)

Population: Freedom from Major Adverse Events within 30 Days of Implant

Outcome measures

Outcome measures
Measure	Endurant AUI Arm n=44 Participants Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair	Endurant Bifurcated Arm n=150 Participants Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
Primary Safety Endpoint (Freedom From MAEs Within 30 Days of Index Procedure)	88.6 percentage of participants	96.0 percentage of participants

PRIMARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure	Endurant AUI Arm n=44 Participants Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair	Endurant Bifurcated Arm n=150 Participants Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
Major Adverse Events Within 30 Days of Index Procedure MAEs within 30 days	11.4 percentage of participants	4.0 percentage of participants
Major Adverse Events Within 30 Days of Index Procedure All Cause Mortality	2.3 percentage of participants	0 percentage of participants
Major Adverse Events Within 30 Days of Index Procedure Myocardial Infarction	6.8 percentage of participants	0.7 percentage of participants
Major Adverse Events Within 30 Days of Index Procedure Respiratory Failure	4.5 percentage of participants	1.3 percentage of participants
Major Adverse Events Within 30 Days of Index Procedure Paraplegia	0 percentage of participants	0 percentage of participants
Major Adverse Events Within 30 Days of Index Procedure Stroke	2.3 percentage of participants	0.7 percentage of participants
Major Adverse Events Within 30 Days of Index Procedure Bowel Ischemia	0 percentage of participants	1.3 percentage of participants
Major Adverse Events Within 30 Days of Index Procedure Procedural Blood Loss > or equal to 1000 cc	4.5 percentage of participants	0.7 percentage of participants
Major Adverse Events Within 30 Days of Index Procedure Renal Failure	2.3 percentage of participants	0.7 percentage of participants

PRIMARY outcome

Timeframe: Intra-operatively

Population: The Technical Success of the Endurant Bifurcated arm was based on obtaining information for the first 121 evaluable subjects available in the clinical study.

Technical success defined as successful delivery and deployment of the stent graft in the planned location and with no unintentional coverage of both the internal iliac arteries or any visceral aortic branches and with removal of the system. Technical success was assessed intra-operatively.

Outcome measures

Outcome measures
Measure	Endurant AUI Arm n=44 Participants Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair	Endurant Bifurcated Arm n=121 Participants Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
Primary Effectiveness Endpoint (Technical Success)	43 participants	118 participants

PRIMARY outcome

Timeframe: 12 months

Population: The number of evaluable subjects for ths endpoint.

Treatment success is defined as Technical success and the following: * Freedom from AAA diameter increased, defined as \>5 mm increase in maximum diameter as measured on CT scan (or MRA/MRI) at 12 months as compared to 1 month * Freedom from Types I and III endoleaks at 12 months including those requiring intervention through 12 months * Freedom from aneurysm rupture through 12 months * Freedom from conversion to surgery through 12 months * Freedom from stent graft migrations resulting in a serious adverse event or requiring secondary intervention through 12 months * Freedom from stent graft occlusion at 12 months

Outcome measures

Outcome measures
Measure	Endurant AUI Arm n=36 Participants Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair	Endurant Bifurcated Arm n=121 Participants Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
Primary Effectiveness Endpoint (Treatment Success) Successful Aneurysm treatment	35 participants	118 participants
Primary Effectiveness Endpoint (Treatment Success) Type I or III Endoleaks through 12 months	0 participants	0 participants
Primary Effectiveness Endpoint (Treatment Success) Aneurysm Rupture through 12 months	0 participants	1 participants
Primary Effectiveness Endpoint (Treatment Success) Conversion to Surgery through 12 months	0 participants	0 participants
Primary Effectiveness Endpoint (Treatment Success) Stent Graft Migration through 12 months	0 participants	0 participants
Primary Effectiveness Endpoint (Treatment Success) Stent Graft occlusion at 12 months	0 participants	1 participants

SECONDARY outcome

Timeframe: 12 months

Population: Number of subjects enrolled in the study arm

The following secondary endpoints were included in the Pivotal trial to evaluate the safety profile of the Endurant Stent Graft System. * Aneurysm-Related Mortality through 12 months * All-Cause Mortality with 30 days * All-Cause Mortality within 12 months * Major Adverse Events through 12 months * Adverse Events through 12 months * Unanticipated Adverse Device Events * Serious Adverse Events (SAEs) As reported at the time of the data cut off. * Device Related Adverse Events * Procedure Related Adverse Events * Adverse Events (excluding SAEs)

Outcome measures

Outcome measures
Measure	Endurant AUI Arm n=44 Participants Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair	Endurant Bifurcated Arm n=150 Participants Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
Secondary Endpoints - Safety Evaluation Freedom from Aneurysm related Mortality through 12	100 percentage of evaluable participants	100 percentage of evaluable participants
Secondary Endpoints - Safety Evaluation Freedom from All Cause Mortality through 30 Days	97.7 percentage of evaluable participants	100 percentage of evaluable participants
Secondary Endpoints - Safety Evaluation Freedom from All Cause Mortality through 12 months	86.4 percentage of evaluable participants	95.7 percentage of evaluable participants
Secondary Endpoints - Safety Evaluation Freedom from MAEs through 12 months	72.7 percentage of evaluable participants	89.2 percentage of evaluable participants
Secondary Endpoints - Safety Evaluation Serious Adverse Events through 12 months	56.8 percentage of evaluable participants	40.7 percentage of evaluable participants
Secondary Endpoints - Safety Evaluation Device Related Adverse Events through 12 months	6.8 percentage of evaluable participants	1.3 percentage of evaluable participants
Secondary Endpoints - Safety Evaluation Procedure Related AEs through 12 month	70.5 percentage of evaluable participants	58.0 percentage of evaluable participants
Secondary Endpoints - Safety Evaluation Adverse Events through 12 months	90.9 percentage of evaluable participants	80.0 percentage of evaluable participants
Secondary Endpoints - Safety Evaluation Unanticipated Adverse Events	0 percentage of evaluable participants	0.6 percentage of evaluable participants

SECONDARY outcome

Timeframe: 12 months

Population: Number of subjects enrolled in the study arm

The following secondary endpoints were included in the pivotal trial to evaluate the effectiveness profile of the Endurant Stent Graft System. * Stent Graft migration through 12 months * Stent Graft Patency through 12 months * All stent Graft Endoleaks at 1-month, 6-months, and 12-month * Secondary Procedures to correct Type I and type III Endoleaks through 12 months * Secondary Endovascular Procedures through 12 months * Technical Observations through 12 months

Outcome measures

Outcome measures
Measure	Endurant AUI Arm n=44 Participants Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair	Endurant Bifurcated Arm n=150 Participants Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
Secondary Endpoint - Effectiveness Evaluation Stent Graft Migration through 12m	0.0 percentage of evaluable subjects	0.0 percentage of evaluable subjects
Secondary Endpoint - Effectiveness Evaluation Stent Graft Patency through 12m	100.0 percentage of evaluable subjects	97.6 percentage of evaluable subjects
Secondary Endpoint - Effectiveness Evaluation All Stent Graft Endoleaks a 1m	14.3 percentage of evaluable subjects	16.1 percentage of evaluable subjects
Secondary Endpoint - Effectiveness Evaluation All Stent Graft Endoleaks a 6m	12.8 percentage of evaluable subjects	11.6 percentage of evaluable subjects
Secondary Endpoint - Effectiveness Evaluation All Stent Graft Endoleaks a 12m	10.5 percentage of evaluable subjects	9.8 percentage of evaluable subjects
Secondary Endpoint - Effectiveness Evaluation Secondary Proced. for Type I & III endoleaks @ 12m	0.0 percentage of evaluable subjects	0.0 percentage of evaluable subjects
Secondary Endpoint - Effectiveness Evaluation Secondary Procedures through 12m	2.6 percentage of evaluable subjects	5.1 percentage of evaluable subjects
Secondary Endpoint - Effectiveness Evaluation Technical Observations through 12m	10.8 percentage of evaluable subjects	3.9 percentage of evaluable subjects

Adverse Events

1. Endurant AUI Arm

Serious events: 25 serious events

Other events: 35 other events

Deaths: 0 deaths

2. Endurant Bifurcated Arm

Serious events: 64 serious events

Other events: 80 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Karla Betz, Principal Clinical Research Specialist

Medtronic

Phone: 763-526-2737

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Publication of single site experience is not allowed until the Multicenter results are published. The Multicenter manuscript will be made available to all authors \& Medtronic prior to submission. Final analysis and review on the multicenter manuscript will require Medtronic approval.
Publication restrictions are in place

Restriction type: OTHER

Measure	1. Endurant AUI Arm n=44 participants at risk Endurant Stent Graft System - Endurant AUI arm	2. Endurant Bifurcated Arm n=150 participants at risk Endurant Stent Graft System - Endurant Bifurcated arm
Blood and lymphatic system disorders Anemia	11.4% 5/44 • Number of events 5 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.	0.00% 0/150 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.
Cardiac disorders New Arrhythmia	0.00% 0/44 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.	5.3% 8/150 • Number of events 10 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.
Cardiac disorders Other Cardiac Complications	6.8% 3/44 • Number of events 3 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.	0.00% 0/150 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.
Gastrointestinal disorders Constipation	0.00% 0/44 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.	10.7% 16/150 • Number of events 16 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.
Gastrointestinal disorders Other Bowel Complications	0.00% 0/44 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.	7.3% 11/150 • Number of events 12 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.
General disorders Fever	15.9% 7/44 • Number of events 7 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.	14.0% 21/150 • Number of events 21 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.
General disorders Other Complications	0.00% 0/44 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.	5.3% 8/150 • Number of events 8 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.
Infections and infestations Urinary Tract Infection	0.00% 0/44 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.	5.3% 8/150 • Number of events 8 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.
Infections and infestations Wound Infection	6.8% 3/44 • Number of events 3 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.	0.00% 0/150 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.
Injury, poisoning and procedural complications Other Wound Complications	9.1% 4/44 • Number of events 4 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.	0.00% 0/150 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.
Injury, poisoning and procedural complications Seroma	0.00% 0/44 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.	12.7% 19/150 • Number of events 20 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.
Investigations Low HCT/Low HGB	6.8% 3/44 • Number of events 3 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.	0.00% 0/150 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.
Investigations Other Complications	0.00% 0/44 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.	6.0% 9/150 • Number of events 9 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.
Metabolism and nutrition disorders Other Complications	20.5% 9/44 • Number of events 11 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.	6.0% 9/150 • Number of events 11 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.
Metabolism and nutrition disorders Other Renal Complications	9.1% 4/44 • Number of events 4 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.	0.00% 0/150 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.
Musculoskeletal and connective tissue disorders Back Pain	6.8% 3/44 • Number of events 3 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.	6.7% 10/150 • Number of events 10 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.
Musculoskeletal and connective tissue disorders Other Complications	9.1% 4/44 • Number of events 5 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.	0.00% 0/150 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.
Nervous system disorders Other Complications	13.6% 6/44 • Number of events 6 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.	0.00% 0/150 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.
Nervous system disorders Other Neurological Complications	13.6% 6/44 • Number of events 8 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.	7.3% 11/150 • Number of events 12 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.
Psychiatric disorders Other Complications	11.4% 5/44 • Number of events 5 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.	0.00% 0/150 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.
Renal and urinary disorders Renal Insufficiency	11.4% 5/44 • Number of events 5 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.	0.00% 0/150 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.
Renal and urinary disorders Urinary Retention	6.8% 3/44 • Number of events 3 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.	0.00% 0/150 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.
Respiratory, thoracic and mediastinal disorders Other Pulmonary Complication	6.8% 3/44 • Number of events 5 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.	0.00% 0/150 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.
Skin and subcutaneous tissue disorders Other Complications	18.2% 8/44 • Number of events 8 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.	6.0% 9/150 • Number of events 9 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.
Vascular disorders Hematoma	11.4% 5/44 • Number of events 5 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.	0.00% 0/150 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.
Vascular disorders Hypertension	11.4% 5/44 • Number of events 5 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.	6.0% 9/150 • Number of events 9 • 12 months Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.