AAA, Abdominal Aortic Aneurysm
Conditions
Brief summary
The purpose of this study is to demonstrate that the Endurant Evo Abdominal Aortic Aneurysm (AAA) stent graft system is safe and effective for endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms.
Detailed description
The clinical evidence collected as part of this trial will be used in conjunction with data collected during the concurrently enrolling Endurant Evo International Clinical Trial.
Interventions
Sponsors
Medtronic Cardiovascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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 understands and voluntarily has signed and dated the Informed Consent approved by the Sponsor and by the Ethics Committee/Institutional Review Board 3. Subject is able and willing to comply with the protocol and to adhere to the follow-up requirements 4. Subject is a suitable candidate for elective surgical repair of AAA as evaluated by American Society of Anesthesiologists (ASA) Physical Status Classification System I, II, or III 5. Subject has an infrarenal abdominal aortic or aortoiliac aneurysm characterized by one or more of the following: * Aneurysm is \>5 cm in diameter (diameter measured is perpendicular to the line of flow) * Aneurysm is 4 - 5 cm in diameter and has increased in size ≥0.5 cm within the previous 6 months 6. Subject meets all the following anatomical criteria as demonstrated on contrast-enhanced computed tomography (CTA) or magnetic resonance angiography (MRA) imaging: * Proximal neck length of ≥ 10 mm with ≤ 60° infrarenal and ≤ 45° suprarenal neck angulation or Proximal neck length of ≥ 15 mm with ≤ 75° infrarenal and ≤ 60° suprarenal neck angulation * Subject has vascular dimensions, e.g., aortic and iliac diameters, lengths from renal arteries to iliac bifurcation and hypogastric arteries, in the range of sizes available for the Endurant Evo AAA stent graft system (measured intima to intima) and within the sizing recommendations (refer to Endurant Evo AAA stent graft system Instructions for Use (IFU)) * Subject has a proximal aortic neck diameter ≥ 18 mm and ≤ 32 mm * The distal fixation center of the iliac arteries must have a diameter ≥ 7 mm and ≤ 25 mm bilaterally for the bifurcation and unilaterally for the Aorto-uni-iliac stent graft (AUI) * Subject has documented imaging evidence of at least one patent iliac and one femoral artery, or can tolerate a vascular conduit that allows introduction of the Endurant Evo AAA stent graft system * Subject has distal non-aneurysmal iliac (cylindrical) fixation length ≥20 mm bilateral for the bifurcation and unilaterally for the AUI
Exclusion criteria
1. Subject has a life expectancy ≤1 year 2. Subject is participating in another investigational drug or device study which would interfere with the endpoints and follow-ups of this study 3. Subject is pregnant 4. Subject has an aneurysm that is: * Suprarenal/pararenal/juxtarenal * Isolated ilio-femoral * Mycotic * Inflammatory * Pseudoaneurysm * Dissecting * Ruptured * Leaking but not ruptured 5. Subject requires emergent aneurysm treatment 6. Subject has a known, untreated thoracic aneurysm \>4.5 cm in diameter at the time of screening 7. Subject has been previously treated for an abdominal aortic aneurysm 8. Subject has a history of bleeding diathesis or coagulopathy 9. Subject has had or plans to have an unrelated major surgical or interventional procedure within 1 month before or after implantation of the Endurant Evo AAA stent graft 10. Subject has had a myocardial infarction (MI) or cerebral vascular accident (CVA) within 3 months prior to implantation of the Endurant Evo AAA stent graft 11. Subject has a conical neck defined as a \>4 mm distal increase from the lowest renal artery over a 10 mm length 12. Subject has a known allergy or intolerance to the device materials 13. Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment 14. Subject has significant aortic thrombus and/or calcification at either the proximal or distal attachment centers that would compromise fixation and seal of the device at the discretion of the investigator 15. Subject has ectatic iliac arteries requiring bilateral exclusion of hypogastric blood flow 16. Subject whose arterial access site is not anticipated to accommodate the diameter of the Endurant Evo AAA stent graft delivery system (13F-17F) due to vessel size, calcification, or tortuosity 17. Subject is morbidly obese or has other documented clinical conditions that severely inhibit radiographic visualization of the aorta at the discretion of the investigator 18. Subject has active infection at the time of the index procedure documented by e.g. pain, fever, drainage, positive culture and/or leukocytosis considered to be clinically significant per investigator discretion 19. Subject has congenital degenerative collagen disease, e.g., Marfan's Syndrome 20. Subject has a creatinine level \> 2.00 mg/dl (or \>176.8 μmol/L) 21. Subject is on dialysis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Subjects Experiencing a Major Adverse Event (MAE) Within 30 Days Post-implantation. | 30-days | The percentage of subjects experiencing a Major Adverse Event (MAE) within 30 days post-implantation. MAEs include the occurrence of any of the following events: * All-cause mortality * Bowel ischemia * Myocardial infarction * Paraplegia * Procedural blood loss ≥1000 cc * Renal failure * Respiratory failure * Stroke |
| The Percentage of Subjects With Both Technical Success at the Time of Index Procedure and Treatment Success at 12-months Post-implantation. | 12-months | Successful aneurysm treatment was achieved based on the following criteria: Technical success at the index procedure (as assessed intra-operatively), defined as successful delivery and deployment of the Endurant Evo AAA Stent graft system in the planned location and with no unintentional coverage of both internal iliac arteries or any visceral aortic branches and with successful removal of the delivery system AND Treatment success consisting of freedom from: * AAA diameter increase, defined as \> 5 mm increase in maximum diameter as measured on computed tomography (CT) scan or magnetic resonance angiography/magnetic resonance imaging (MRA/MRI) at 12-month follow-up as compared to 1-month imaging * Types I and III endoleaks at 12-month follow-up including those requiring intervention through 12 months * Aneurysm rupture within 365 days * Conversion to surgery within 365 days * Stent graft migration resulting in a serious adverse event or requiring seco |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Procedures to Correct Type I and III Endoleaks | within 183, and 365 days | Any reintervention procedure (surgical or endovascular) following the completion of the operative initial implantation procedure that is used to correct a Type I and III endoleaks within 183 and 365 days. Type I endoleak was defined as a leak resulting from an incomplete seal of the endograft proximally or distally and a Type III endoleak was defined as a leak resulting from a defect of fabric or between the segments of the modular graft (junctional endoleak. |
| Secondary Procedures | within 183, and 365 days | Secondary procedures within 183 and 365 days |
| Serious Adverse Events | within 30, 183, and 365 days | Serious adverse events within 30, 183 and 365 days. |
| Conversion to Open Surgery | within 183, and 365 days | Conversion to open surgery within 183, and 365 days |
| Aneurysm Rupture | within 183 and 365 days | Aneurysm rupture within 183 and 365 days |
| All-cause Mortality | within 30, 183, and 365 days | All-cause mortality (ACM) within 30, 183, 365 days |
| Stent Graft Migration | At 6- and 12-month follow-up visits (as compared to 1-month imaging) | Stent graft movement of either the main body or iliac limb distally or proximally at 6- and 12-month follow-up visits (as compared to 1-month imaging). Main body stent graft migration is defined as evidence of movement of the main body stent graft relative to fixed anatomic landmarks, which is not due to remodeling of the subject's vasculature. Migration is observed when the stent graft completely covers a renal artery or movement is \> 10 mm either distally or proximally. Stent graft limb/extension migration is defined as evidence of a movement of the stent graft limbs/extensions relative to fixed anatomic landmarks, which is not due to remodeling of the subject's vasculature that is \> 10 mm or coverage of the internal iliac artery. |
| Aneurysm Expansion >5 mm | at 6- and 12-month follow-up visits (as compared to 1-month imaging) | Aneurysm expansion \>5 mm at 6- and 12-month follow-up visits (as compared to 1-month imaging) |
| All Endoleaks Based on Imaging Findings | at 1-, 6-, and 12-month follow-up visits | All endoleaks based on imaging findings at 1-month, 6-month and 12-month. An endoleak is defined by the presence of contrast-enhanced blood outside the lumen of the endoluminal graft but within the aneurysm sac as seen on computed tomography (CT), angiography, ultrasound, or other appropriate imaging modality. |
| Stent Graft Occlusions Based on Imaging Findings | Through 1-, 6- and 12 months | Stent graft occlusions based on imaging findings through 1-, 6- and 12 months. Stent graft occlusion is defined as a 100% blockage of the lumen diameter of any implanted stent graft component(s) as evidenced by CT, angiography, ultrasound, or other appropriate imaging modality, and/or operative or pathological analysis. |
| Device Deficiencies Based on Imaging Findings | Through 6- and 12 months | Device deficiencies based on imaging findings through 6- and 12 months. A device deficiency was defined according Inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance (ref. ISO 14155:2011 3.15). |
| Major Adverse Events | within 183 and 365 days | Major adverse events within 183 and 365 days |
| Aneurysm-related Mortality (ARM) | within 30, 183, and 365 days | Aneurysm-related mortality (ARM) within 30, 183, and 365 days |
Countries
United States
Participant flow
Recruitment details
Global enrollment was stopped at 139 out of 140 planned. Enrollment start date: 20 April 2015
Participants by arm
| Arm | Count |
|---|---|
| Endovascular Repair Endurant Evo AAA Stent Graft System
Endurant Evo AAA Stent Graft System
Endovascular aneurysm repair (EVAR) | 139 |
| Total | 139 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 29 |
| Overall Study | Device Explanted | 8 |
| Overall Study | Missed visit | 16 |
| Overall Study | Withdrawal by Subject | 8 |
Baseline characteristics
| Characteristic | Endovascular Repair | — |
|---|---|---|
| Age, Continuous | 71.7 years STANDARD_DEVIATION 7.4 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Europe | 69 participants | — |
| Region of Enrollment United States | 70 participants | — |
| Sex: Female, Male Female | 15 Participants | — |
| Sex: Female, Male Male | 124 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 29 / 139 |
| other Total, other adverse events | 38 / 139 |
| serious Total, serious adverse events | 105 / 139 |
Outcome results
Primary
The Percentage of Subjects Experiencing a Major Adverse Event (MAE) Within 30 Days Post-implantation.
The percentage of subjects experiencing a Major Adverse Event (MAE) within 30 days post-implantation. MAEs include the occurrence of any of the following events: * All-cause mortality * Bowel ischemia * Myocardial infarction * Paraplegia * Procedural blood loss ≥1000 cc * Renal failure * Respiratory failure * Stroke
Time frame: 30-days
Population: Globally, 4 out 139 Subjects experienced a MAE within 30 days (2.9%).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Endovascular Repair | The Percentage of Subjects Experiencing a Major Adverse Event (MAE) Within 30 Days Post-implantation. | 4 Participants |
Comparison: The primary safety endpoint was tested against a predetermined safety Performance Goal (PG) using the following statistical hypotheses:~H0: p ≥ 20% vs. H1: p \< 20% where p is the proportion of subjects experiencing a MAE within 30 days of the index procedure in the target population of subjects treated with the Endurant Evo AAA Stent graft system and 20% is the safety PG.p-value: <0.001Based on exact binomial distribution
Primary
The Percentage of Subjects With Both Technical Success at the Time of Index Procedure and Treatment Success at 12-months Post-implantation.
Successful aneurysm treatment was achieved based on the following criteria: Technical success at the index procedure (as assessed intra-operatively), defined as successful delivery and deployment of the Endurant Evo AAA Stent graft system in the planned location and with no unintentional coverage of both internal iliac arteries or any visceral aortic branches and with successful removal of the delivery system AND Treatment success consisting of freedom from: * AAA diameter increase, defined as \> 5 mm increase in maximum diameter as measured on computed tomography (CT) scan or magnetic resonance angiography/magnetic resonance imaging (MRA/MRI) at 12-month follow-up as compared to 1-month imaging * Types I and III endoleaks at 12-month follow-up including those requiring intervention through 12 months * Aneurysm rupture within 365 days * Conversion to surgery within 365 days * Stent graft migration resulting in a serious adverse event or requiring seco
Time frame: 12-months
Population: While the full 139 subjects were evaluable for Technical Success at index procedure, 118 subjects were evaluable for treatment success at 12 month follow up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Endovascular Repair | The Percentage of Subjects With Both Technical Success at the Time of Index Procedure and Treatment Success at 12-months Post-implantation. | Primary Effectiveness (Technical Success) | 139 Participants |
| Endovascular Repair | The Percentage of Subjects With Both Technical Success at the Time of Index Procedure and Treatment Success at 12-months Post-implantation. | Primary effectiveness (Technical Success and treatment Success) | 113 Participants |
Comparison: The primary effectiveness endpoint was tested against a predetermined effectiveness PG using following statistical hypotheses:~H0: q ≤ 80% vs. H1: q \> 80% where q is the proportion of subjects who have a successful aneurysm treatment in the target population of subjects treated with the Endurant Evo AAA Stent graft system and 80% is the effectiveness PG.p-value: <0.001Based on exact binomial distribution
Secondary
All-cause Mortality
All-cause mortality (ACM) within 30, 183, 365 days
Time frame: within 30, 183, and 365 days
Population: At 0-365 days, 138 subjects were evaluable
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Endovascular Repair | All-cause Mortality | All-Cause Mortality 0-30 Days | 1 Participants |
| Endovascular Repair | All-cause Mortality | All-Cause Mortality 0-183 Days | 4 Participants |
| Endovascular Repair | All-cause Mortality | All-Cause Mortality 0-365 Days | 8 Participants |
Secondary
All Endoleaks Based on Imaging Findings
All endoleaks based on imaging findings at 1-month, 6-month and 12-month. An endoleak is defined by the presence of contrast-enhanced blood outside the lumen of the endoluminal graft but within the aneurysm sac as seen on computed tomography (CT), angiography, ultrasound, or other appropriate imaging modality.
Time frame: at 1-, 6-, and 12-month follow-up visits
Population: At 1-month 134, subjects were evaluable. At 6-months, 124 subjects were evaluable. 12-months 117 subjects were evaluable
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Endovascular Repair | All Endoleaks Based on Imaging Findings | 1-month. Participants with any type of endoleak | 45 Participants |
| Endovascular Repair | All Endoleaks Based on Imaging Findings | 6-months. Participants with any type of endoleak | 29 Participants |
| Endovascular Repair | All Endoleaks Based on Imaging Findings | 12-months. Participants with any type of endoleak | 29 Participants |
Secondary
Aneurysm Expansion >5 mm
Aneurysm expansion \>5 mm at 6- and 12-month follow-up visits (as compared to 1-month imaging)
Time frame: at 6- and 12-month follow-up visits (as compared to 1-month imaging)
Population: At 6-months, 130 subjects were evaluable. At 12-months, 123 subjects were evaluable.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Endovascular Repair | Aneurysm Expansion >5 mm | 6-months | 2 Participants |
| Endovascular Repair | Aneurysm Expansion >5 mm | 12-months | 2 Participants |
Secondary
Aneurysm-related Mortality (ARM)
Aneurysm-related mortality (ARM) within 30, 183, and 365 days
Time frame: within 30, 183, and 365 days
Population: In 0-365 days, 133 subjects were evaluable for Aneurysm related mortality
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Endovascular Repair | Aneurysm-related Mortality (ARM) | Aneurysm-related mortality (ARM) 0-30 days | 1 Participants |
| Endovascular Repair | Aneurysm-related Mortality (ARM) | Aneurysm-related mortality (ARM) 0-183 days | 1 Participants |
| Endovascular Repair | Aneurysm-related Mortality (ARM) | Aneurysm-related mortality (ARM) 0-365 days | 1 Participants |
Secondary
Aneurysm Rupture
Aneurysm rupture within 183 and 365 days
Time frame: within 183 and 365 days
Population: In 0-183 days, 138 subjects were evaluable In 0-365 days, 132 subjects were evaluable
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Endovascular Repair | Aneurysm Rupture | 0-183 days | 0 Participants |
| Endovascular Repair | Aneurysm Rupture | 0-365 days | 0 Participants |
Secondary
Conversion to Open Surgery
Conversion to open surgery within 183, and 365 days
Time frame: within 183, and 365 days
Population: In 0-183 days, 138 subjects were evaluable In 0-365 days, 133 were evaluable
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Endovascular Repair | Conversion to Open Surgery | 0-183 days | 1 Participants |
| Endovascular Repair | Conversion to Open Surgery | 0-365 days | 2 Participants |
Secondary
Device Deficiencies Based on Imaging Findings
Device deficiencies based on imaging findings through 6- and 12 months. A device deficiency was defined according Inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance (ref. ISO 14155:2011 3.15).
Time frame: Through 6- and 12 months
Population: Through 6-months, 125 subjects were evaluable. Through 12-months, 126 subjects were evaluable.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Endovascular Repair | Device Deficiencies Based on Imaging Findings | 6-months. Any device deficiency. | 27 Participants |
| Endovascular Repair | Device Deficiencies Based on Imaging Findings | 12-months. Any device deficiency. | 41 Participants |
Secondary
Major Adverse Events
Major adverse events within 183 and 365 days
Time frame: within 183 and 365 days
Population: In 0-183 days, 139 subjects were evaluable In 0-365 days, 138 subjects were evaluable
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Endovascular Repair | Major Adverse Events | 0-183 days | 10 Participants |
| Endovascular Repair | Major Adverse Events | 0-365 days | 16 Participants |
Secondary
Secondary Procedures
Secondary procedures within 183 and 365 days
Time frame: within 183, and 365 days
Population: In 0-183 days, 138 subjects were evaluable In 0-365 days, 134 subjects were evaluable
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Endovascular Repair | Secondary Procedures | 0-183 days | 2 Participants |
| Endovascular Repair | Secondary Procedures | 0-365 days | 6 Participants |
Secondary
Secondary Procedures to Correct Type I and III Endoleaks
Any reintervention procedure (surgical or endovascular) following the completion of the operative initial implantation procedure that is used to correct a Type I and III endoleaks within 183 and 365 days. Type I endoleak was defined as a leak resulting from an incomplete seal of the endograft proximally or distally and a Type III endoleak was defined as a leak resulting from a defect of fabric or between the segments of the modular graft (junctional endoleak.
Time frame: within 183, and 365 days
Population: In 0-183 days, 138 subjects were evaluable In 0-365 days, 132 subjects were evaluable
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Endovascular Repair | Secondary Procedures to Correct Type I and III Endoleaks | 0-183 days | 0 Participants |
| Endovascular Repair | Secondary Procedures to Correct Type I and III Endoleaks | 0-365 days | 1 Participants |
Secondary
Serious Adverse Events
Serious adverse events within 30, 183 and 365 days.
Time frame: within 30, 183, and 365 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Endovascular Repair | Serious Adverse Events | 0-183 days | 48 Participants |
| Endovascular Repair | Serious Adverse Events | 0-365 days | 60 Participants |
| Endovascular Repair | Serious Adverse Events | 0-30 days | 25 Participants |
Secondary
Stent Graft Migration
Stent graft movement of either the main body or iliac limb distally or proximally at 6- and 12-month follow-up visits (as compared to 1-month imaging). Main body stent graft migration is defined as evidence of movement of the main body stent graft relative to fixed anatomic landmarks, which is not due to remodeling of the subject's vasculature. Migration is observed when the stent graft completely covers a renal artery or movement is \> 10 mm either distally or proximally. Stent graft limb/extension migration is defined as evidence of a movement of the stent graft limbs/extensions relative to fixed anatomic landmarks, which is not due to remodeling of the subject's vasculature that is \> 10 mm or coverage of the internal iliac artery.
Time frame: At 6- and 12-month follow-up visits (as compared to 1-month imaging)
Population: At 6-months, 124 subjects were evaluable At 12-months, 121 subjects were evaluable
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Endovascular Repair | Stent Graft Migration | 6-months | 1 Participants |
| Endovascular Repair | Stent Graft Migration | 12-months | 2 Participants |
Secondary
Stent Graft Occlusions Based on Imaging Findings
Stent graft occlusions based on imaging findings through 1-, 6- and 12 months. Stent graft occlusion is defined as a 100% blockage of the lumen diameter of any implanted stent graft component(s) as evidenced by CT, angiography, ultrasound, or other appropriate imaging modality, and/or operative or pathological analysis.
Time frame: Through 1-, 6- and 12 months
Population: Through 1-month, 136 subjects were evaluable. Through 6-months, 124 subjects were evaluable. Through 12-months, 120 subjects were evaluable.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Endovascular Repair | Stent Graft Occlusions Based on Imaging Findings | 1-month | 0 Participants |
| Endovascular Repair | Stent Graft Occlusions Based on Imaging Findings | 6-months | 1 Participants |
| Endovascular Repair | Stent Graft Occlusions Based on Imaging Findings | 12-months | 1 Participants |