Thoracic Aortic Aneurysm
Conditions
Keywords
Thoracic Aneurysm, Endovascular Aortic Repair (EVAR), Endovascular Stent Graft, Endograft, Thoracic Aortic Aneurysm, Endovascular procedure, Descending Thoracic Aneurysm, Valiant Stent Graft System
Brief summary
This study was designed to study safety and effectiveness of the Valiant Thoracic Stent Graft to treat thoracic aortic aneurysms.
Detailed description
The aorta is a large blood vessel that carries blood away from the heart to the organs in the rest of the body. An aneurysm is a weakening in the artery wall that will become a bulge in the aorta. If left untreated, this bulge may continue to grow larger and may rupture (break open) with fatal consequences. In this research study we are investigating a device that can be placed in the aorta to exclude the weakened part of the artery wall and restore blood flow. Information will be collected on the performance of the device for 5 years.
Interventions
DEVICEValiant Thoracic Stent Graft System
Surgical procedure in which a device is implanted inside the aorta, isolating the diseased area (aneurysm).
Sponsors
Medtronic Cardiovascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
The following inclusion/
Exclusion criteria
was obtained from the study protocol. INCLUSION CRITERIA To be eligible for enrollment, a subject must meet all of the following inclusion criteria: 1. Subject is between the age of 18 and 85. 2. Subject must be considered a candidate for elective surgical repair of the TAA (i.e., low-to-moderate risk \[categories 0, 1, and 2\] per the modified SVS/AAVS scoring system at the time of implant). See Appendix B: Modified SVS/AAVS Medical Co-Morbidity Grading System 3. If subject is female of childbearing potential, she must have a negative pregnancy test within 7 days before the implant procedure. 4. Subject has a DTA that is: 1. A fusiform aneurysm with a maximum diameter of ≥ 5 cm OR is \> 2 times the diameter of the non-aneurysmal thoracic aorta; AND/OR 2. Saccular aneurysm (penetrating atherosclerotic ulcer) 5. Subject's anatomy must meet all of the following anatomical criteria: 1. Subject's TAA must be ≥ 20 mm distal to the origin of the left common carotid artery and must be ≥ 20 mm proximal to the celiac artery; 2. Proximal and distal non-aneurysmal neck diameter measurements must be between 20 mm and 42 mm; 3. Proximal and distal non-aneurysmal neck must be ≥ 20 mm in length. 6. Thoracic aortic lesion is confirmed, at a minimum, by diagnostic contrast enhanced computerized tomography (CT) with optional 3-D reconstruction, and/or contrast enhanced Magnetic Resonance Angiogram obtained within four (4) months prior to the implant procedure. 7. Subject is able and willing to comply with the protocol and undergo follow-up requirements. 8. Subject or subject's legal representative understands and has signed an Informed Consent approved by the Sponsor and by the IRB for this study. 9. Subject has patent iliac or femoral arteries or can tolerate a vascular conduit that allows endovascular access to the aneurysmal site with the delivery system of the appropriate size device chosen for treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants That Did NOT Experience Aneurysm-Related Mortality (Post-market Primary Endpoint) | 0 through 1825 days post treatment | Evaluation of the ARM-free rate in subjects implanted with the Valiant Thoracic Stent Graft five years post-implantation by comparing it to a pre-defined performance goal (PG) based on an analysis of ARM-free rates from TEVAR data and on results from the VALOR (Talent Thoracic Endoluminal Stent Graft, IDE G980116) clinical study. |
| Percentage of Participants With Successful Aneurysm Treatment (Primary Effectiveness Endpoint) | At 12-month post procedure | Percentage of subjects with absence of both: a) aneurysm growth of more than 5 mm at the 12-month visit relative to the 1-month visit; and b) secondary procedure due to type I or III endoleak performed or recommended at or before the 12-month visit. Success means a subject experienced neither a nor b. Type I: endoleak in continuity with the proximal anchoring site(proximal endoleak) or the distal anchoring site(distal endoleak)of the device. Type III: endoleak is present in the mid-graft region due to defect of fabric or between the segments of the modular graft (junctional endoleak). |
| Percentage of Participants Who Died (Primary Safety Endpoint: All-Cause Mortality) > > | Within 12-months post treatment | The percentage of participants who died within 12-months of the initial procedure, whether or not the cause of death was related to the study device, procedure, or condition treated. \> \> Note: All-cause mortality endpoint is not directly related to successful aneurysm treatment, which pertains to the absence of aneurysm growth and secondary procedure due to Type I and III endoleaks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants That Experienced Paraplegia | Within 30 days post treatment | Percentage of subjects that experienced paraplegia within 30 days post treatment |
| Percentage of Participants That Experienced Paraparesis | Within 30 days post treatment | Percentage of subjects that experienced paraparesis within 30 days post treatment |
| Percentage of Participants That Experienced Secondary Procedures Due to Endoleak After Discharge | Within 30 days post treatment | Percentage of subjects that experienced secondary procedures due to endoleak after discharge within 30 days post treatment |
| Percentage of Participants That Experienced One or More Major Adverse Events | Within 30 days post treatment | Percentage of subjects that experienced one or more major adverse events within 30 days post treatment, regardless of relatedness to study device |
| Percentage of Participants That Experienced Aneurysm-related Mortality | Within 12 months post treatment | Percentage of subjects that experienced aneurysm-related mortality within 12 months post treatment |
| Percentage of Participants That Experience Aneurysm Rupture | Within 12 months post treatment | Percentage of subjects that experience aneurysm rupture within 12 months post treatment |
| Percentage of Participants That Experienced Conversion to Open Surgical Repair | Within 12 months post treatment | Percentage of subjects that experienced conversion to open surgical repair within 12 months post treatment |
| Percentage of Participants That Experienced Endoleak(s) | At 12 months | Percentage of subjects that experienced endoleak(s) of any type at 12 months |
| Percentage of Participants That Experienced Secondary Endovascular Procedures Due to Endoleak | Between 30 days and 12 months | Percentage of subjects that experienced secondary endovascular procedures due to endoleak between 30 days and 12 months |
| Percentage of Participants That Experienced Conversions to Open Surgical Repair | 0 through 1825 days post treatment | Percentage of subjects that experienced conversions to open surgical repair within five years post implant |
| Percentage of Participants That Experience Loss of Stent Graft Patency | Within 12 months post treatment | Percentage of subjects that experience loss of stent graft patency within 12 months post treatment |
| Percentage of Participants That Died (All-cause Mortality) | 0 through 1825 days post treatment | Percentage of subjects that died (all-cause mortality) five years post implant, regardless whether or not the cause of death was related to procedure, device, or condition treated |
| Percentage of Participants That Experienced Aneurysm Ruptures | 0 through 1825 days post treatment | Percentage of subjects that experienced aneurysm ruptures within five years post implant |
| Percentage of Participants That Experienced Type I Endoleaks | 0 through 1825 days post treatment | Percentage of subjects that experienced type I endoleaks within five years post implant |
| Percentage of Participants That Experienced Type III Endoleaks | 0 through 1825 days post treatment | Percentage of subjects that experienced type III endoleaks within five years post implant |
| Percentage of Participants That Experienced Type IV Endoleaks | 0 through 1825 days post treatment | Percentage of subjects that experienced type IV endoleaks within five years post implant |
| Percentage of Participants That Experienced Secondary Endovascular Procedures | 0 through 1825 days post treatment | Percentage of subjects that experienced secondary endovascular procedures within five years post implant |
| Percentage of Participants That Experienced Stent Graft Migrations (Site Reported) | 0 through 1825 days post treatment | Percentage of subjects that experienced stent graft migrations within five years post implant, as reported by the clinical sites |
| Percentage of Participants That Experienced Loss of Stent Graft Patency | 0 through 1825 days post treatment | Percentage of subjects that experienced loss of stent graft patency within five years post implant |
| Percentage of Participants That Experienced Stent Graft Migration | Within 12 months post treatment | Percentage of subjects that experienced stent graft migration within 12 months post treatment, as reported by the CEC. Of note, all migrations resulted from anatomical accommodation of the stent graft. All migrations were at the distal end of the stent graft, moving proximally. No endoleaks were associated to these migrations. |
| Percentage of Subjects That Experienced Successful Deployment and Delivery of the Stent Graft at Implant | At implant | Percentage of subjects that experienced successful deployment and delivery of the stent graft at implant. Successful deployment and delivery of the stent graft is used to measure effectiveness. |
| Percentage of Participants That Experienced Perioperative Mortality | Within 30 days post treatment | Percentage of subjects that experienced perioperative mortality. Perioperative morality is defined as all-cause mortality within 30 days after index procedure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Valiant Thoracic Stent Graft System Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System). | 160 |
| Total | 160 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 0 to 30-day Post Treatment | Death | 5 |
| 0 to 30-day Post Treatment | Intend to treat, but not implanted | 3 |
| 30-day to 365-day Post Treatment | Death | 13 |
| 365-day to 60-month Post Treatment | Death | 36 |
| 365-day to 60-month Post Treatment | Exited after surgical conversion | 1 |
| 365-day to 60-month Post Treatment | Lost to Follow-up | 4 |
| 365-day to 60-month Post Treatment | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Valiant Thoracic Stent Graft System |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 134 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants |
| Age, Continuous | 72.2 years STANDARD_DEVIATION 9.1 |
| Region of Enrollment United States | 160 participants |
| Sex: Female, Male Female | 65 Participants |
| Sex: Female, Male Male | 95 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 160 / 160 |
| serious Total, serious adverse events | 135 / 160 |
Outcome results
Primary
Percentage of Participants That Did NOT Experience Aneurysm-Related Mortality (Post-market Primary Endpoint)
Evaluation of the ARM-free rate in subjects implanted with the Valiant Thoracic Stent Graft five years post-implantation by comparing it to a pre-defined performance goal (PG) based on an analysis of ARM-free rates from TEVAR data and on results from the VALOR (Talent Thoracic Endoluminal Stent Graft, IDE G980116) clinical study.
Time frame: 0 through 1825 days post treatment
Population: Subjects treated or intended to treat with the test device
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valiant Thoracic Stent Graft System | Percentage of Participants That Did NOT Experience Aneurysm-Related Mortality (Post-market Primary Endpoint) | 94.8 Percentage of participants |
Primary
Percentage of Participants Who Died (Primary Safety Endpoint: All-Cause Mortality) > >
The percentage of participants who died within 12-months of the initial procedure, whether or not the cause of death was related to the study device, procedure, or condition treated. \> \> Note: All-cause mortality endpoint is not directly related to successful aneurysm treatment, which pertains to the absence of aneurysm growth and secondary procedure due to Type I and III endoleaks.
Time frame: Within 12-months post treatment
Population: Subjects treated or intended to treat with the test device
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valiant Thoracic Stent Graft System | Percentage of Participants Who Died (Primary Safety Endpoint: All-Cause Mortality) > > | 12.6 Percentage of Participants |
Primary
Percentage of Participants With Successful Aneurysm Treatment (Primary Effectiveness Endpoint)
Percentage of subjects with absence of both: a) aneurysm growth of more than 5 mm at the 12-month visit relative to the 1-month visit; and b) secondary procedure due to type I or III endoleak performed or recommended at or before the 12-month visit. Success means a subject experienced neither a nor b. Type I: endoleak in continuity with the proximal anchoring site(proximal endoleak) or the distal anchoring site(distal endoleak)of the device. Type III: endoleak is present in the mid-graft region due to defect of fabric or between the segments of the modular graft (junctional endoleak).
Time frame: At 12-month post procedure
Population: Subjects treated or intended to treat with the test device
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valiant Thoracic Stent Graft System | Percentage of Participants With Successful Aneurysm Treatment (Primary Effectiveness Endpoint) | 97.4 Percentage of Participants |
Secondary
Percentage of Participants That Died (All-cause Mortality)
Percentage of subjects that died (all-cause mortality) five years post implant, regardless whether or not the cause of death was related to procedure, device, or condition treated
Time frame: 0 through 1825 days post treatment
Population: Subjects treated or intended to treat with the test device
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valiant Thoracic Stent Graft System | Percentage of Participants That Died (All-cause Mortality) | 33.8 Percentage of participants |
Secondary
Percentage of Participants That Experience Aneurysm Rupture
Percentage of subjects that experience aneurysm rupture within 12 months post treatment
Time frame: Within 12 months post treatment
Population: Subjects treated or intended to treat with the test device excluding subjects that exited before 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valiant Thoracic Stent Graft System | Percentage of Participants That Experience Aneurysm Rupture | 0 Percentage of participants |
Secondary
Percentage of Participants That Experienced Aneurysm-related Mortality
Percentage of subjects that experienced aneurysm-related within five years post implant
Time frame: 0 through 1825 days post treatment
Population: Subjects treated or intended to treat with the test device
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valiant Thoracic Stent Graft System | Percentage of Participants That Experienced Aneurysm-related Mortality | 5 Percentage of participants |
Secondary
Percentage of Participants That Experienced Aneurysm-related Mortality
Percentage of subjects that experienced aneurysm-related mortality within 12 months post treatment
Time frame: Within 12 months post treatment
Population: Subjects treated or intended to treat with the test device, excluding subjects exited before 12 months and implant failures
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valiant Thoracic Stent Graft System | Percentage of Participants That Experienced Aneurysm-related Mortality | 3.3 Percentage of participants |
Secondary
Percentage of Participants That Experienced Aneurysm Ruptures
Percentage of subjects that experienced aneurysm ruptures within five years post implant
Time frame: 0 through 1825 days post treatment
Population: Subjects treated or intended to treat with the test device
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valiant Thoracic Stent Graft System | Percentage of Participants That Experienced Aneurysm Ruptures | 1.3 Percentage of participants |
Secondary
Percentage of Participants That Experienced Conversions to Open Surgical Repair
Percentage of subjects that experienced conversions to open surgical repair within five years post implant
Time frame: 0 through 1825 days post treatment
Population: Subjects treated or intended to treat with the test device
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valiant Thoracic Stent Graft System | Percentage of Participants That Experienced Conversions to Open Surgical Repair | 0.6 Percentage of participants |
Secondary
Percentage of Participants That Experienced Conversion to Open Surgical Repair
Percentage of subjects that experienced conversion to open surgical repair within 12 months post treatment
Time frame: Within 12 months post treatment
Population: Subjects treated or intended to treat with the test device excluding subjects exited before 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valiant Thoracic Stent Graft System | Percentage of Participants That Experienced Conversion to Open Surgical Repair | 0 Percentage of participants |
Secondary
Percentage of Participants That Experienced Endoleak(s)
Percentage of subjects that experienced endoleak(s) of any type at 12 months
Time frame: At 12 months
Population: Subjects treated or intended to treat with the test device excluding subjects that did not have proper imaging to identify endoleaks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valiant Thoracic Stent Graft System | Percentage of Participants That Experienced Endoleak(s) | 13 Percentage of participants |
Secondary
Percentage of Participants That Experienced Loss of Stent Graft Patency
Percentage of subjects that experienced loss of stent graft patency within five years post implant
Time frame: 0 through 1825 days post treatment
Population: Subjects treated or intended to treat with the test device
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valiant Thoracic Stent Graft System | Percentage of Participants That Experienced Loss of Stent Graft Patency | 0 Percentage of participants |
Secondary
Percentage of Participants That Experienced One or More Major Adverse Events
Percentage of subjects that experienced one or more Major Adverse Events within 12 months post treatment
Time frame: Within 12 months post treatment
Population: Subjects treated or intended to treat with the test device, excluded subjects that exited before 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valiant Thoracic Stent Graft System | Percentage of Participants That Experienced One or More Major Adverse Events | 48.7 Percentage of participants |
Secondary
Percentage of Participants That Experienced One or More Major Adverse Events
Percentage of subjects that experienced one or more major adverse events within 30 days post treatment, regardless of relatedness to study device
Time frame: Within 30 days post treatment
Population: Subjects treated or intended to treat with the test device
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valiant Thoracic Stent Graft System | Percentage of Participants That Experienced One or More Major Adverse Events | 38.1 Percentage of participants |
Secondary
Percentage of Participants That Experienced Paraparesis
Percentage of subjects that experienced paraparesis within 30 days post treatment
Time frame: Within 30 days post treatment
Population: Subjects treated or intended to treat with the test device
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valiant Thoracic Stent Graft System | Percentage of Participants That Experienced Paraparesis | 1.9 Percentage of participants |
Secondary
Percentage of Participants That Experienced Paraplegia
Percentage of subjects that experienced paraplegia within 30 days post treatment
Time frame: Within 30 days post treatment
Population: Subjects treated or intended to treat with the test device
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valiant Thoracic Stent Graft System | Percentage of Participants That Experienced Paraplegia | 0.6 Percentage of participants |
Secondary
Percentage of Participants That Experienced Perioperative Mortality
Percentage of subjects that experienced perioperative mortality. Perioperative morality is defined as all-cause mortality within 30 days after index procedure.
Time frame: Within 30 days post treatment
Population: Subjects treated or intended to treat with the test device
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valiant Thoracic Stent Graft System | Percentage of Participants That Experienced Perioperative Mortality | 3.1 Percentage of participants |
Secondary
Percentage of Participants That Experienced Secondary Endovascular Procedures
Percentage of subjects that experienced secondary endovascular procedures within five years post implant
Time frame: 0 through 1825 days post treatment
Population: Subjects treated or intended to treat with the test device
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valiant Thoracic Stent Graft System | Percentage of Participants That Experienced Secondary Endovascular Procedures | 6.9 Percentage of participants |
Secondary
Percentage of Participants That Experienced Secondary Endovascular Procedures Due to Endoleak
Percentage of subjects that experienced secondary endovascular procedures due to endoleak between 30 days and 12 months
Time frame: Between 30 days and 12 months
Population: Subjects treated or intended to treat with the test device excluding censored subjects (those with no data within the time frame)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valiant Thoracic Stent Graft System | Percentage of Participants That Experienced Secondary Endovascular Procedures Due to Endoleak | 0 Percentage of participants |
Secondary
Percentage of Participants That Experienced Secondary Procedures Due to Endoleak After Discharge
Percentage of subjects that experienced secondary procedures due to endoleak after discharge within 30 days post treatment
Time frame: Within 30 days post treatment
Population: Subjects treated or intended to treat with the test device
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valiant Thoracic Stent Graft System | Percentage of Participants That Experienced Secondary Procedures Due to Endoleak After Discharge | 0.6 Percentage of participants |
Secondary
Percentage of Participants That Experienced Stent Graft Migration
Percentage of subjects that experienced stent graft migration within 12 months post treatment, as reported by the CEC. Of note, all migrations resulted from anatomical accommodation of the stent graft. All migrations were at the distal end of the stent graft, moving proximally. No endoleaks were associated to these migrations.
Time frame: Within 12 months post treatment
Population: Subjects treated or intended to treat with the test device, excluding subjects that did not have proper imaging
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valiant Thoracic Stent Graft System | Percentage of Participants That Experienced Stent Graft Migration | 2.9 Percentage of participants |
Secondary
Percentage of Participants That Experienced Stent Graft Migrations (Site Reported)
Percentage of subjects that experienced stent graft migrations within five years post implant, as reported by the clinical sites
Time frame: 0 through 1825 days post treatment
Population: Subjects treated or intended to treat with the test device
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valiant Thoracic Stent Graft System | Percentage of Participants That Experienced Stent Graft Migrations (Site Reported) | 0 Percentage of participants |
Secondary
Percentage of Participants That Experienced Type I Endoleaks
Percentage of subjects that experienced type I endoleaks within five years post implant
Time frame: 0 through 1825 days post treatment
Population: Subjects treated or intended to treat with the test device
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valiant Thoracic Stent Graft System | Percentage of Participants That Experienced Type I Endoleaks | 8.1 Percentage of participants |
Secondary
Percentage of Participants That Experienced Type III Endoleaks
Percentage of subjects that experienced type III endoleaks within five years post implant
Time frame: 0 through 1825 days post treatment
Population: Subjects treated or intended to treat with the test device
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valiant Thoracic Stent Graft System | Percentage of Participants That Experienced Type III Endoleaks | 0.6 Percentage of participants |
Secondary
Percentage of Participants That Experienced Type IV Endoleaks
Percentage of subjects that experienced type IV endoleaks within five years post implant
Time frame: 0 through 1825 days post treatment
Population: Subjects treated or intended to treat with the test device
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valiant Thoracic Stent Graft System | Percentage of Participants That Experienced Type IV Endoleaks | 1.3 Percentage of participants |
Secondary
Percentage of Participants That Experience Loss of Stent Graft Patency
Percentage of subjects that experience loss of stent graft patency within 12 months post treatment
Time frame: Within 12 months post treatment
Population: Subjects treated or intended to treat with the test device, excluding subjects that did not have proper imaging
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valiant Thoracic Stent Graft System | Percentage of Participants That Experience Loss of Stent Graft Patency | 0 Percentage of participants |
Secondary
Percentage of Subjects That Experienced Successful Deployment and Delivery of the Stent Graft at Implant
Percentage of subjects that experienced successful deployment and delivery of the stent graft at implant. Successful deployment and delivery of the stent graft is used to measure effectiveness.
Time frame: At implant
Population: Subjects treated or intended to treat with the test device
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valiant Thoracic Stent Graft System | Percentage of Subjects That Experienced Successful Deployment and Delivery of the Stent Graft at Implant | 96.3 Percentage of participants |