Aortic Aneurysm, Thoracic
Conditions
Brief summary
The purpose of the Valiant Evo International Clinical Trial is to demonstrate the safety and effectiveness of the Valiant Evo Thoracic Stent Graft System in subjects with a descending thoracic aortic aneurysm (DTAA) who are candidates for endovascular repair.
Detailed description
Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 total subjects, in order obtain 87 evaluable subjects for the primary endpoint. The two protocols are identical, and the trials were run simultaneously to enroll subjects concurrently in the United States (US) and Outside United States (OUS). The poolability on the primary endpoint between US and OUS data will be assessed using Fisher's exact test during the data analysis. Data for both trials will be combined and presented as a pooled analysis.
Interventions
Procedure: thoracic endovascular aneurysm repair (TEVAR)
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 Patient Informed Consent approved by the Sponsor and by the Ethics Committee for this study 3. Subject presents a DTAA which is localized below the ostium of left subclavian artery (LSA) and above the ostium of celiac trunk 4. Subject has a DTAA that is one of the following: 1. A fusiform aneurysm with a maximum diameter that: * is ≥ 50 mm and/or: * is ≥ 2 times the diameter of the non-aneurysmal thoracic aorta and/or: * is \<50 mm and has grown ≥ 5 mm within previous 12 months 2. A saccular aneurysm or a penetrating atherosclerotic ulcer 5. Subject's anatomy must meet all of the following anatomical criteria as demonstrated on contrast-enhanced CT and/or on contrast-enhanced MRI obtained within four (4) months prior to implant procedure: 1. Proximal and distal non-aneurysmal aortic neck diameter measurements must be ≥ 16 mm and ≤ 42 mm 2. Proximal non-aneurysmal aortic neck length must be ≥ 20 mm (for FreeFlo configuration) and ≥ 25 mm (for Closed Web configuration) 3. Distal non-aneurysmal aortic neck length must be ≥ 20 mm 6. Subject has adequate arterial access site or can tolerate a conduit that allows endovascular access to the aneurysmal site with the delivery system of the appropriate sized device chosen for the treatment.
Exclusion criteria
1. Subject has a life expectancy of less than 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 requires planned placement of the covered proximal end of the stent graft to occur in zones 0 or 1 5. Subject has a thoracic aneurysm with a contained rupture or localized at the anastomosis of a previous graft (pseudo-/false aneurysm) 6. Subject has a mycotic aneurysm 7. Subject has a dissection (type A or B) or an intramural hematoma or an aortic rupture in addition to the thoracic aneurysm 8. Subject requires emergent aneurysm treatment, e.g., trauma or rupture 9. Subject has received a previous stent or stent graft or previous surgical repair in the ascending and/or descending thoracic aorta, and/or in the aortic arch 10. Subject requires surgical or endovascular treatment of an infra-renal aneurysm at the time of implant 11. Subject has had previous surgical or endovascular treatment of an infra-renal aortic aneurysm 12. Treatment with the Valiant Evo Thoracic Stent Graft would require intentional revascularization of the brachio-cephalic artery, the left common carotid artery or the celiac trunk 13. Subject has had or plans to have a major surgical or interventional procedure within 30 days before or 30 days after the planned implantation of the Valiant Evo Thoracic Stent Graft. This does not include planned procedures that are needed for the safe and effective placement of the stent graft (i.e., carotid/subclavian transposition, carotid/subclavian bypass procedure) 14. Subject has a significant and/or circumferential aortic mural thrombus at either the proximal or distal attachment sites that could compromise fixation and seal of the implanted stent graft 15. Subject has a connective tissue disease (e.g., Marfan's syndrome, aortic medial degeneration) 16. Subject has a bleeding diathesis or coagulopathy, or refuses blood transfusion. 17. Subject has had a myocardial infarction (MI) within 3 months of the procedure 18. Subject has had a Cerebrovascular Accident (CVA) within 3 months of the procedure 19. Subject has a known allergy or intolerance to the device materials 20. Subject has a known allergy to anesthetic drugs 21. Subject has a known hypersensitivity or contraindication to anticoagulants, or contrast media, which is not amenable to pretreatment 22. Subject has active or systemic infection at the time of the index procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Safety and Effectiveness Endpoint That is Based on the Percentage of Subjects Who Experienced (a) Access and/or Deployment Failures; and/or (b) Major Device Effect (MDE) Within 30 Days Post Index Procedure | 30 Days | MDEs include: device-related secondary procedures, device-related mortality, conversion to open surgery, thoracic aortic aneurysm rupture. Access failure: Inability to insert device due to mechanical failure or anatomic exclusions of the femoral or iliac arteries. Deployment failure: Deployment failure due to subject anatomy or mechanical failure. Specifically, deployment of the stent graft from the delivery system. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the primary endpoint global cohort of 87 subjects. The poolability on the primary endpoint between US and OUS data were assessed using Fisher's exact test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Effectiveness Outcome | 30 Days | Safety and Effectiveness outcome measures between 0-30 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 Outside US \[OUS\]). Measures include: peri-operative mortality, adverse events (AE), major adverse events (MAE), serious adverse events (SAE), secondary procedures, loss of stent graft patency, and endoleaks. |
Countries
Canada, Denmark, France, Italy, Netherlands, United Kingdom
Participant flow
Recruitment details
100 subjects (53 US, 47 Outside US \[OUS\]), from 18 US sites and 15 OUS sites, contributed to the global cohort. The 1st subject was enrolled on 25 April 2016 (US) & on 08 June 2016 (OUS), the 100th subject on 28 March 2018.
Pre-assignment details
A total of 152 subjects were consented to be reviewed for enrollment. 52 subjects were not approved for implantation, 100 subjects were approved for implantation. The 30-day primary endpoint was evaluated when 87 subjects completed 30-day follow-up.
Participants by arm
| Arm | Count |
|---|---|
| Endovascular Repair Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysm (DTAA) and who met the inclusion and exclusion criteria. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 Outside US \[OUS\]). | 100 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 12-Month Follow-up Secondary Endpoint | Death | 4 |
| 24-Month Follow-up Secondary Endpoint | Death | 2 |
| 24-Month Follow-up Secondary Endpoint | Lost to Follow-up | 2 |
| 24-Month Follow-up Secondary Endpoint | Subject declined reconsenting to extended follow-up out to 5 years | 28 |
| 24-Month Follow-up Secondary Endpoint | Withdrawal by Subject | 3 |
| 30-Day Follow-up for Primary Endpoint | Death | 1 |
| 30-Day Follow-up for Secondary Endpoint | Death | 1 |
| 36-Month Follow-up Secondary Endpoint | Death | 2 |
| 36-Month Follow-up Secondary Endpoint | Withdrawal by Subject | 2 |
| 48-Month Follow-up Secondary Endpoint | Death | 4 |
| 48-Month Follow-up Secondary Endpoint | Lost to Follow-up | 1 |
| 48-Month Follow-up Secondary Endpoint | Withdrawal by Subject | 1 |
| 60-Month Follow-up Secondary Endpoint | Death | 5 |
| 60-Month Follow-up Secondary Endpoint | Withdrawal by Subject | 1 |
| 6-Month Follow-up Subject Accountability | Death | 5 |
| 6-Month Follow-up Subject Accountability | Lost to Follow-up | 1 |
| 6-Month Follow-up Subject Accountability | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Endovascular Repair |
|---|---|
| Age, Continuous | 70.8 years STANDARD_DEVIATION 8.9 |
| Race/Ethnicity, Customized Non-White | 11 Participants |
| Race/Ethnicity, Customized White | 42 Participants |
| Region of Enrollment Canada | 7 participants |
| Region of Enrollment Denmark | 1 participants |
| Region of Enrollment France | 10 participants |
| Region of Enrollment Italy | 17 participants |
| Region of Enrollment Netherlands | 4 participants |
| Region of Enrollment United Kingdom | 8 participants |
| Region of Enrollment United States | 53 participants |
| Sex: Female, Male Female | 40 Participants |
| Sex: Female, Male Male | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 100 | 6 / 99 | 10 / 97 | 13 / 80 | 14 / 78 | 20 / 71 | 23 / 66 |
| other Total, other adverse events | 62 / 100 | 32 / 98 | 20 / 91 | 21 / 84 | 14 / 66 | 16 / 62 | 14 / 49 |
| serious Total, serious adverse events | 32 / 100 | 27 / 98 | 22 / 91 | 17 / 84 | 14 / 66 | 17 / 62 | 15 / 49 |
Outcome results
Primary
Composite Safety and Effectiveness Endpoint That is Based on the Percentage of Subjects Who Experienced (a) Access and/or Deployment Failures; and/or (b) Major Device Effect (MDE) Within 30 Days Post Index Procedure
MDEs include: device-related secondary procedures, device-related mortality, conversion to open surgery, thoracic aortic aneurysm rupture. Access failure: Inability to insert device due to mechanical failure or anatomic exclusions of the femoral or iliac arteries. Deployment failure: Deployment failure due to subject anatomy or mechanical failure. Specifically, deployment of the stent graft from the delivery system. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the primary endpoint global cohort of 87 subjects. The poolability on the primary endpoint between US and OUS data were assessed using Fisher's exact test.
Time frame: 30 Days
Population: The 30-day primary endpoint was evaluated for Premarket Approval (PMA) when 87 subjects completed 30 day follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Endovascular Repair | Composite Safety and Effectiveness Endpoint That is Based on the Percentage of Subjects Who Experienced (a) Access and/or Deployment Failures; and/or (b) Major Device Effect (MDE) Within 30 Days Post Index Procedure | 2 Participants |
Comparison: The primary study endpoint, major device effect at 30 days, is a dichotomous study outcome; hence, an exact method based on the binomial distribution was used for the hypothesis testing. The primary study endpoint was tested against a performance goal of 16%:~H0: p ≥ 16% vs. Ha: p \<16%, where p denotes the true event rate of primary study endpoint in the target population.p-value: <0.0001Exact binomial test
Secondary
Safety and Effectiveness Outcome
Safety and Effectiveness outcome measures between 0-30 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 Outside US \[OUS\]). Measures include: peri-operative mortality, adverse events (AE), major adverse events (MAE), serious adverse events (SAE), secondary procedures, loss of stent graft patency, and endoleaks.
Time frame: 30 Days
Population: Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 OUS).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Endovascular Repair | Safety and Effectiveness Outcome | Loss of Stent Graft Patency | 0 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Peri-Operative Mortality | 2 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Adverse Events (AE) | 72 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Major Adverse Events (MAE) | 29 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Serious Adverse Events (SAE) | 32 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Secondary Procedures | 2 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Endoleaks | 4 Participants |
Secondary
Safety and Effectiveness Outcome
Safety outcome measures between 0-183 days and Effectiveness outcome measures between 31-183 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort. Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month.
Time frame: 6 Month
Population: Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International Trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 Outside US).~Note that 6-month follow up is not mandatory for subjects enrolled under the Valiant Evo International protocol, resulting in fewer subjects analyzed at 6 months.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Endovascular Repair | Safety and Effectiveness Outcome | Major Adverse Events (MAE) | 39 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | All-Cause Mortality (ACM) | 6 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Aneurysm-Related Mortality (ARM) | 3 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Major Device Effects (MDE) | 2 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Adverse Events (AE) | 80 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Serious Adverse Events (SAE) | 50 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Secondary Procedures | 4 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Loss of Stent Graft Patency | 0 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Endoleaks | 3 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Stent Graft Migration | 0 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Aneurysm Expansion >5 mm relative to 1-Month | 1 Participants |
Secondary
Safety and Effectiveness Outcome
Safety outcome measures between 0-365 days and Effectiveness outcome measures between 184-365 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort. Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month.
Time frame: 12 Month
Population: Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 OUS).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Endovascular Repair | Safety and Effectiveness Outcome | Serious Adverse Events (SAE) | 55 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Secondary Procedures | 5 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | All-Cause Mortality (ACM) | 10 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Aneurysm-Related Mortality (ARM) | 3 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Major Device Effects (MDE) | 4 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Adverse Events (AE) | 82 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Major Adverse Events (MAE) | 44 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Loss of Stent Graft Patency | 0 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Endoleaks | 5 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Stent Graft Migration | 0 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Aneurysm Expansion >5 mm relative to 1-Month | 4 Participants |
Secondary
Safety and Effectiveness Outcome
Safety outcome measures between 0-730 days and Effectiveness outcome measures between 366-730 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort. Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month.
Time frame: 24 Month
Population: Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysm and who met the inclusion and exclusion criteria. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 OUS).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Endovascular Repair | Safety and Effectiveness Outcome | Aneurysm-Related Mortality (ARM) | 3 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Major Device Effects (MDE) | 5 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | All-Cause Mortality (ACM) | 13 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Adverse Event (AE) | 85 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Major Adverse Event (MAE) | 49 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Serious Adverse Event (SAE) | 62 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Secondary Procedures | 6 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Loss of Stent Graft Patency | 0 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Endoleaks | 2 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Stent Graft Migration | 0 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Aneurysm Expansion >5 mm relative to 1-Month | 4 Participants |
Secondary
Safety and Effectiveness Outcome
Safety outcome measures between 0-1095 days and Effectiveness outcome measures between 731-1095 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort. Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month.
Time frame: 36 Month
Population: Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysm and who met the inclusion and exclusion criteria. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 OUS).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Endovascular Repair | Safety and Effectiveness Outcome | Endoleaks | 3 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | All-Cause Mortality | 14 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Aneurysm-Related Mortality | 3 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Major Device Effects (MDE) | 6 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Adverse Event (AE) | 88 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Major Adverse Event (MAE) | 52 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Serious Adverse Event (SAE) | 66 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Secondary Procedures | 6 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Loss of Stent Graft Patency | 0 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Stent Graft Migration | 1 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Aneurysm Expansion >5mm relative to 1-Month | 4 Participants |
Secondary
Safety and Effectiveness Outcome
Safety outcome measures between 0-1460 days and Effectiveness outcome measures between 1096-1460 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort. Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects(MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month.
Time frame: 48 month
Population: Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysm and who met the inclusion and exclusion criteria. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 OUS).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Endovascular Repair | Safety and Effectiveness Outcome | Secondary Procedures | 9 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | All-Cause Mortality (ACM) | 20 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Aneurysm-Related Mortality (ARM) | 4 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Major Device Effects (MDE) | 8 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Adverse Events (AE) | 90 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Major Adverse Events (MAE) | 55 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Serious Adverse Events (SAE) | 69 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Loss of Stent Graft Patency | 0 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Endoleaks | 6 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Stent Graft Migration | 2 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Aneurysm Expansion>5 mm relative to 1-Month | 6 Participants |
Secondary
Safety and Effectiveness Outcome
Safety and Effectiveness outcome measures between implant procedure and 60 months. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort. Measures include: aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE), secondary procedures, loss of stent graft patency, stent graft migration compared to 1 month imaging, aneurysm expansion greater than 5 mm compared to 1 month imaging, and endoleaks.
Time frame: 60 Month
Population: Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysm and who met the inclusion and exclusion criteria. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 OUS).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Endovascular Repair | Safety and Effectiveness Outcome | All-Cause Mortality (ACM) | 23 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Aneurysm-Related Mortality (ARM) | 4 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Major Device Effects (MDE) | 13 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Adverse Events (AE) | 93 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Major Adverse Events (MAE) | 59 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Serious Adverse Events (SAE) | 75 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Secondary Procedures | 14 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Loss of Stent Graft Patency | 0 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Endoleaks | 8 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Stent Graft Migration | 2 Participants |
| Endovascular Repair | Safety and Effectiveness Outcome | Aneurysm Expansion >5 mm relative to 1-Month | 5 Participants |