Abdominal Aortic Aneurysms
Conditions
Keywords
Endurant Stent Graft System, Abdominal Aortic Aneurysms, Endovascular Treatment
Brief summary
To demonstrate safety and effectiveness of the Endurant Stent Graft in the treatment of Abdominal Aortic or Aorto-Uni-Iliac Aneurysms.
Detailed description
Prospective, two-arm, non-randomized, multicenter clinical study enrolling subjects treated with the bifurcated stent graft in one arm and subjects treated with the AUI in a second arm.
Interventions
Abdominal Aortic Aneurysm Repair
Sponsors
Medtronic Cardiovascular
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is ≥ 18 years old. 2. Subject (or Subject's legal representative) understands and voluntarily has signed and dated an Informed Consent document approved by the Sponsor and by the Institutional Review Board. 3. Subject is able and willing to comply with the protocol and undergo follow-up requirements. 4. Subject is a suitable candidate for elective surgical repair of AAA by as evaluated by American Society of Anesthesiologists (ASA) Physical Status Classification System I, II, III, or IV 5. Subject has an abdominal aortic or aortoiliac aneurysm characteristics that meet protocol parameter 6. Subject meets all the protocol anatomical criteria\* as demonstrated on contrast-enhanced CT or MRA 7. Subject has vascular dimensions in the range of sizes available for the Endurant Stent Graft 8. Subject has documented imaging evidence of at least 1 patent iliac and 1 femoral artery, or can tolerate a vascular conduit that allows introduction of the device. 9. Subject's native vessel anatomy is more suited for the introduction and/ or deployment of an Endurant Uni-Iliac Stent Graft System.
Exclusion criteria
1. Subject has a life expectancy \< 1 year 2. Subject is participating in another investigational drug or device study 3. Subject requires emergent aneurysm treatment 4. Subject is a female of childbearing potential in whom pregnancy cannot be excluded. 5. Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment. 6. Subject is morbidly obese (body mass index ≥ 40 kg/m2) or has other documented clinical conditions that severely inhibit radiographic visualization of the aorta.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint (Freedom From MAEs Within 30 Days of Index Procedure) | 30 days (Safety) | 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 |
| Major Adverse Events Within 30 Days of Index Procedure | 30 days | 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 |
| Primary Effectiveness Endpoint (Technical Success) | Intra-operatively | 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. |
| Primary Effectiveness Endpoint (Treatment Success) | 12 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Endpoints - Safety Evaluation | 12 months | 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) |
| Secondary Endpoint - Effectiveness Evaluation | 12 months | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Endurant AUI Arm Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair | 44 |
| Endurant Bifurcated Arm Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair | 150 |
| Total | 194 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 6 | 6 |
| Overall Study | Follow up not done | 1 | 4 |
| Overall Study | Not due for Visit | 0 | 12 |
Baseline characteristics
| Characteristic | Endurant Bifurcated Arm | Total | Endurant AUI Arm |
|---|---|---|---|
| Age, Continuous | 73.1 years STANDARD_DEVIATION 8 | 73.3 years STANDARD_DEVIATION 7.9 | 73.8 years STANDARD_DEVIATION 7.6 |
| Baseline Medical History Abnormal renal function | 43 participants | 57 participants | 14 participants |
| Baseline Medical History Angina | 27 participants | 38 participants | 11 participants |
| Baseline Medical History Arrhythmia | 59 participants | 74 participants | 15 participants |
| Baseline Medical History Chronic obstructive pulmonary disorder | 53 participants | 79 participants | 26 participants |
| Baseline Medical History Congestive Heart Failure | 24 participants | 31 participants | 7 participants |
| Baseline Medical History Diabetes | 40 participants | 51 participants | 11 participants |
| Baseline Medical History Hypertension | 130 participants | 168 participants | 38 participants |
| Baseline Medical History Myocardial Infarction | 45 participants | 59 participants | 14 participants |
| Baseline Medical History Peripheral vascular disease | 34 participants | 67 participants | 33 participants |
| Baseline Medical History Tabacco use in the last 10 years | 66 participants | 95 participants | 29 participants |
| Region of Enrollment Canada | 0 participants | 3 participants | 3 participants |
| Region of Enrollment United States | 150 participants | 191 participants | 41 participants |
| Sex: Female, Male Female | 13 Participants | 27 Participants | 14 Participants |
| Sex: Female, Male Male | 137 Participants | 167 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 35 / 44 | 80 / 150 |
| serious Total, serious adverse events | 25 / 44 | 64 / 150 |
Outcome results
Primary
Major Adverse Events Within 30 Days of Index Procedure
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
Time frame: 30 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Endurant AUI Arm | Major Adverse Events Within 30 Days of Index Procedure | Myocardial Infarction | 6.8 percentage of participants |
| Endurant AUI Arm | Major Adverse Events Within 30 Days of Index Procedure | Stroke | 2.3 percentage of participants |
| Endurant AUI Arm | Major Adverse Events Within 30 Days of Index Procedure | All Cause Mortality | 2.3 percentage of participants |
| Endurant AUI Arm | Major Adverse Events Within 30 Days of Index Procedure | Bowel Ischemia | 0 percentage of participants |
| Endurant AUI Arm | Major Adverse Events Within 30 Days of Index Procedure | Respiratory Failure | 4.5 percentage of participants |
| Endurant AUI Arm | Major Adverse Events Within 30 Days of Index Procedure | Procedural Blood Loss > or equal to 1000 cc | 4.5 percentage of participants |
| Endurant AUI Arm | Major Adverse Events Within 30 Days of Index Procedure | MAEs within 30 days | 11.4 percentage of participants |
| Endurant AUI Arm | Major Adverse Events Within 30 Days of Index Procedure | Renal Failure | 2.3 percentage of participants |
| Endurant AUI Arm | Major Adverse Events Within 30 Days of Index Procedure | Paraplegia | 0 percentage of participants |
| Endurant Bifurcated Arm | Major Adverse Events Within 30 Days of Index Procedure | Renal Failure | 0.7 percentage of participants |
| Endurant Bifurcated Arm | Major Adverse Events Within 30 Days of Index Procedure | MAEs within 30 days | 4.0 percentage of participants |
| Endurant Bifurcated Arm | Major Adverse Events Within 30 Days of Index Procedure | All Cause Mortality | 0 percentage of participants |
| Endurant Bifurcated Arm | Major Adverse Events Within 30 Days of Index Procedure | Myocardial Infarction | 0.7 percentage of participants |
| Endurant Bifurcated Arm | Major Adverse Events Within 30 Days of Index Procedure | Respiratory Failure | 1.3 percentage of participants |
| Endurant Bifurcated Arm | Major Adverse Events Within 30 Days of Index Procedure | Paraplegia | 0 percentage of participants |
| Endurant Bifurcated Arm | Major Adverse Events Within 30 Days of Index Procedure | Stroke | 0.7 percentage of participants |
| Endurant Bifurcated Arm | Major Adverse Events Within 30 Days of Index Procedure | Bowel Ischemia | 1.3 percentage of participants |
| Endurant Bifurcated Arm | Major Adverse Events Within 30 Days of Index Procedure | Procedural Blood Loss > or equal to 1000 cc | 0.7 percentage of participants |
Primary
Primary Effectiveness Endpoint (Technical Success)
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Endurant AUI Arm | Primary Effectiveness Endpoint (Technical Success) | 43 participants |
| Endurant Bifurcated Arm | Primary Effectiveness Endpoint (Technical Success) | 118 participants |
Primary
Primary Effectiveness Endpoint (Treatment Success)
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
Time frame: 12 months
Population: The number of evaluable subjects for ths endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Endurant AUI Arm | Primary Effectiveness Endpoint (Treatment Success) | Successful Aneurysm treatment | 35 participants |
| Endurant AUI Arm | Primary Effectiveness Endpoint (Treatment Success) | Type I or III Endoleaks through 12 months | 0 participants |
| Endurant AUI Arm | Primary Effectiveness Endpoint (Treatment Success) | Aneurysm Rupture through 12 months | 0 participants |
| Endurant AUI Arm | Primary Effectiveness Endpoint (Treatment Success) | Conversion to Surgery through 12 months | 0 participants |
| Endurant AUI Arm | Primary Effectiveness Endpoint (Treatment Success) | Stent Graft Migration through 12 months | 0 participants |
| Endurant AUI Arm | Primary Effectiveness Endpoint (Treatment Success) | Stent Graft occlusion at 12 months | 0 participants |
| Endurant Bifurcated Arm | Primary Effectiveness Endpoint (Treatment Success) | Stent Graft Migration through 12 months | 0 participants |
| Endurant Bifurcated Arm | Primary Effectiveness Endpoint (Treatment Success) | Successful Aneurysm treatment | 118 participants |
| Endurant Bifurcated Arm | Primary Effectiveness Endpoint (Treatment Success) | Conversion to Surgery through 12 months | 0 participants |
| Endurant Bifurcated Arm | Primary Effectiveness Endpoint (Treatment Success) | Type I or III Endoleaks through 12 months | 0 participants |
| Endurant Bifurcated Arm | Primary Effectiveness Endpoint (Treatment Success) | Stent Graft occlusion at 12 months | 1 participants |
| Endurant Bifurcated Arm | Primary Effectiveness Endpoint (Treatment Success) | Aneurysm Rupture through 12 months | 1 participants |
Primary
Primary Safety Endpoint (Freedom From MAEs Within 30 Days of Index Procedure)
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
Time frame: 30 days (Safety)
Population: Freedom from Major Adverse Events within 30 Days of Implant
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Endurant AUI Arm | Primary Safety Endpoint (Freedom From MAEs Within 30 Days of Index Procedure) | 88.6 percentage of participants |
| Endurant Bifurcated Arm | Primary Safety Endpoint (Freedom From MAEs Within 30 Days of Index Procedure) | 96.0 percentage of participants |
Secondary
Secondary Endpoint - Effectiveness Evaluation
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
Time frame: 12 months
Population: Number of subjects enrolled in the study arm
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Endurant AUI Arm | Secondary Endpoint - Effectiveness Evaluation | Stent Graft Migration through 12m | 0.0 percentage of evaluable subjects |
| Endurant AUI Arm | Secondary Endpoint - Effectiveness Evaluation | Stent Graft Patency through 12m | 100.0 percentage of evaluable subjects |
| Endurant AUI Arm | Secondary Endpoint - Effectiveness Evaluation | All Stent Graft Endoleaks a 1m | 14.3 percentage of evaluable subjects |
| Endurant AUI Arm | Secondary Endpoint - Effectiveness Evaluation | All Stent Graft Endoleaks a 6m | 12.8 percentage of evaluable subjects |
| Endurant AUI Arm | Secondary Endpoint - Effectiveness Evaluation | All Stent Graft Endoleaks a 12m | 10.5 percentage of evaluable subjects |
| Endurant AUI Arm | Secondary Endpoint - Effectiveness Evaluation | Secondary Proced. for Type I & III endoleaks @ 12m | 0.0 percentage of evaluable subjects |
| Endurant AUI Arm | Secondary Endpoint - Effectiveness Evaluation | Secondary Procedures through 12m | 2.6 percentage of evaluable subjects |
| Endurant AUI Arm | Secondary Endpoint - Effectiveness Evaluation | Technical Observations through 12m | 10.8 percentage of evaluable subjects |
| Endurant Bifurcated Arm | Secondary Endpoint - Effectiveness Evaluation | Technical Observations through 12m | 3.9 percentage of evaluable subjects |
| Endurant Bifurcated Arm | Secondary Endpoint - Effectiveness Evaluation | Stent Graft Migration through 12m | 0.0 percentage of evaluable subjects |
| Endurant Bifurcated Arm | Secondary Endpoint - Effectiveness Evaluation | All Stent Graft Endoleaks a 12m | 9.8 percentage of evaluable subjects |
| Endurant Bifurcated Arm | Secondary Endpoint - Effectiveness Evaluation | Stent Graft Patency through 12m | 97.6 percentage of evaluable subjects |
| Endurant Bifurcated Arm | Secondary Endpoint - Effectiveness Evaluation | Secondary Procedures through 12m | 5.1 percentage of evaluable subjects |
| Endurant Bifurcated Arm | Secondary Endpoint - Effectiveness Evaluation | All Stent Graft Endoleaks a 1m | 16.1 percentage of evaluable subjects |
| Endurant Bifurcated Arm | Secondary Endpoint - Effectiveness Evaluation | Secondary Proced. for Type I & III endoleaks @ 12m | 0.0 percentage of evaluable subjects |
| Endurant Bifurcated Arm | Secondary Endpoint - Effectiveness Evaluation | All Stent Graft Endoleaks a 6m | 11.6 percentage of evaluable subjects |
Secondary
Secondary Endpoints - Safety Evaluation
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)
Time frame: 12 months
Population: Number of subjects enrolled in the study arm
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Endurant AUI Arm | Secondary Endpoints - Safety Evaluation | Freedom from All Cause Mortality through 30 Days | 97.7 percentage of evaluable participants |
| Endurant AUI Arm | Secondary Endpoints - Safety Evaluation | Device Related Adverse Events through 12 months | 6.8 percentage of evaluable participants |
| Endurant AUI Arm | Secondary Endpoints - Safety Evaluation | Freedom from MAEs through 12 months | 72.7 percentage of evaluable participants |
| Endurant AUI Arm | Secondary Endpoints - Safety Evaluation | Procedure Related AEs through 12 month | 70.5 percentage of evaluable participants |
| Endurant AUI Arm | Secondary Endpoints - Safety Evaluation | Freedom from All Cause Mortality through 12 months | 86.4 percentage of evaluable participants |
| Endurant AUI Arm | Secondary Endpoints - Safety Evaluation | Adverse Events through 12 months | 90.9 percentage of evaluable participants |
| Endurant AUI Arm | Secondary Endpoints - Safety Evaluation | Serious Adverse Events through 12 months | 56.8 percentage of evaluable participants |
| Endurant AUI Arm | Secondary Endpoints - Safety Evaluation | Unanticipated Adverse Events | 0 percentage of evaluable participants |
| Endurant AUI Arm | Secondary Endpoints - Safety Evaluation | Freedom from Aneurysm related Mortality through 12 | 100 percentage of evaluable participants |
| Endurant Bifurcated Arm | Secondary Endpoints - Safety Evaluation | Unanticipated Adverse Events | 0.6 percentage of evaluable participants |
| Endurant Bifurcated Arm | Secondary Endpoints - Safety Evaluation | Freedom from Aneurysm related Mortality through 12 | 100 percentage of evaluable participants |
| Endurant Bifurcated Arm | Secondary Endpoints - Safety Evaluation | Freedom from All Cause Mortality through 30 Days | 100 percentage of evaluable participants |
| Endurant Bifurcated Arm | Secondary Endpoints - Safety Evaluation | Freedom from All Cause Mortality through 12 months | 95.7 percentage of evaluable participants |
| Endurant Bifurcated Arm | Secondary Endpoints - Safety Evaluation | Freedom from MAEs through 12 months | 89.2 percentage of evaluable participants |
| Endurant Bifurcated Arm | Secondary Endpoints - Safety Evaluation | Serious Adverse Events through 12 months | 40.7 percentage of evaluable participants |
| Endurant Bifurcated Arm | Secondary Endpoints - Safety Evaluation | Device Related Adverse Events through 12 months | 1.3 percentage of evaluable participants |
| Endurant Bifurcated Arm | Secondary Endpoints - Safety Evaluation | Procedure Related AEs through 12 month | 58.0 percentage of evaluable participants |
| Endurant Bifurcated Arm | Secondary Endpoints - Safety Evaluation | Adverse Events through 12 months | 80.0 percentage of evaluable participants |