Valiant™ Captivia™ Thoracic Stent Graft Delivery System
VALOR II Valiant Thoracic Stent Graft System Pivotal Study
The VALOR II Valiant Thoracic Stent Graft System Pivotal Study was designed to evaluate the safety and effectiveness of the Valiant Thoracic Stent Graft in the treatment of fusiform thoracic aortic aneurysms, saccular aneurysms, and penetrating aortic ulcers of the decending thoracic aorta.
|Study End Points||At 12 months|
|Successful aneurysm treatment*||97.4%
|Study End Points||Through 5 Years|
|Aneurysm-related mortlllty||5.0% (8/160 patients)|
|Aneurysm rupture||1.3% (2/160 patients)|
|Conversion to open surgical repair||0.6% (1/160 patients)|
|Proximal stentgraft migration > 10mm proximally||0.0% (0/70 patients)|
|Proximal stent graft migration > 10mm distally||0.0% (0/70 patients)|
|Distal stent graft migration > 10mm proximally||0.0% (0/70 patients)|
|Distal stent graft migration > 10mm distally||0.0% (0/70 patients)|
|Study End Points||At 5 Years|
|Type I Endoleak||0.0% (0/60 patients)|
|Type II Endoleak||1.7% (1/60 patients)|
|Type III Endoleak||0.0% (0/60 patients)|
|Type IV Endoleak||0.0% (0/60 patients)|
|Study End Points||At 30 days|
|Paraplegia||0.6% (1/160 patients)|
|Paraparesis||1.9% (3/160 patients)|
Valiant Thoracic Stent Graft with the Captivia Delivery System - Instructions for Use © 2015
* Successful aneurysm treatment was a composite endpoint that included the absence of: a) aneurysm growth of more than 5mm 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.
Medtronic Dissection Trial details
The Medtronic Dissection Trial was designed to evaluate the safety and effectiveness of the Valiant thoracic stent graft in the treatment of acute, complicated Type B dissection, as determined by all-cause mortality within 30 days of the index procedure, compared to a performance goal based on TEVAR and open surgical repair outcomes.
The primary endpoint for this trial was the all-cause mortality within 30 days of the index procedure. The Medtronic Dissection Trial met its primary endpoint with a 30-day all-cause mortality rate of 8.0%. Four (4) subjects died within 30 days of the index procedure.
Primary Endpoint–All-Cause Mortality within 30 Days
|% (m/n) [95% UCL] 1,2,3|
|30-Day All-Cause Mortality||8.0% (4/50) [17.4%]|
1 95% Upper Confidence Limit (UCL) was calcualted using an exact method based on the binomial distribution.
2 Based on the number of evaluated subjects. Subjects will be considered unevaluable if they are withdrawn before the lower limit of the 30-day follow-up window (16 days) or if they are lost to follow-up before the lower limit of the 30-day follow-up window (16 days) and had no contact thereafter.
3 Based on CEC adjudicated data
- Valiant™ Captivia™ system demonstrates safety and effectiveness in the treatment of acute, complicated Type B aortic dissections
- Valiant Captivia is stabilizing the aorta
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‡ All-cause mortality
† Dissection-related mortality
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Source: Medtronic Dissection Trial Results, Clinical Study Report
Main Clinical Findings through 2 Years
Treatment of trial patients resulted in:
- 100% delivery and deployment success
- 100% coverage of primary entry tear at index procedure
- 3 CVA / 1 CVI
- No conversions to open repair and four patients with dissection-related reinterventions
- No incidents of post-operative rupture
- Favorable remodeling over stented segment
2016 Annual physician clinical update Valiant™ Thoracic Stent Graft with the Captivia™ Delivery System.
RESCUE Trial details
The RESCUE study was designed to evaluate the clinical performance of the Valiant thoracic stent graft for treatment of blunt thoracic aortic injury (BTAI).
The primary endpoint for this study included all enrolled subjects and was measured by the all-cause mortality rate within 30 days. As shown in the table below, four (4) subjects died within 30 days of the index procedure. This result demonstrates a 30-day all-cause mortality rate of 8.0% for BTAI subjects treated with the Valiant thoracic stent graft.
|Primary Endpoint||% (m/n)|
|30-day All-Cause Mortality||8.0% (4/50)|
m = number of subjects in category, n = number of subjects enrolled in this study.
Site and clinical events committee (CEC) Adjudicated Reported Table.
within 30 days
|Relatedness Site Reported||Relatedness CEC Adjudicated|
|Any procedure, Aorta or Device Related AE||12.0% (6/50)||N/A|
|Any Procedure Related AE||10.0% (5/50)||N/A|
|Any Aorta Related AE||2.0% (1/50)||N/A|
|Any Device Related AE||0% (0/50)||N/A|
|SAEs Leading to Death1|
|Hemothorax||Not Related||Aortic Related|
|Traumatic Brain Injury||Not Related||Not Related|
|Arrhythmia||Not Related||Not Related|
|Complications of Multiple
Blunt Force Injuries
|Not Evaluable Device Related,
Not Evaluable Aortic Related,
Not Related to Procedure
|SAEs Not Leading to Death|
|Femoral Artery Dissection2||Procedure Related||N/A|
|Anoxic Encephalopathy3||Aortic Related||N/A|
|Left Arm Ischemia4,5||Procedure Related||N/A|
|Left Arm Clauducation6||Procedure Related||N/A|
|Incision Site Erythema8||Procedure Related||N/A|
1 These are the only events adjudicated by the CEC, as the CEC is only responsible for adjudicating deaths and UADE’s.
2 Subject had a right common femoral artery focal dissection during index procedure. Subject underwent a thrombectomy and patch angioplasty and the event resolved the same day.
3 Subject developed an anoxic brain injury related to the rupture on the day of the procedure. This subject’s discharge summary notes mentioned that “the patient’s course was complicated by hypoxicischemic encephalopathy secondary to significant hypotension and hypoxia after the accident as well as intra-operatively” prior to the deployment of the stent graft. Additionally this subject experienced another SAE: infection, on day 169 post procedure that led to death.
4 Subject had peripheral ischemia on day seven (7), LSA was intentionally (partially) covered during initial procedure. Subject underwent a left carotid to subclavian bypass on day eight (8) and the ischemia resolved the next day.
5 Subject experienced upper left limb ischemia on day 36 post procedure, related to the procedure. During the procedure, the physician intentionally completely covered the left subclavian artery (LSA). The subject eventually developed signs of upper left extremity ischemia. This subject underwent a left carotid to subclavian bypass on day 36 post procedure that led to resolution of the event on the day of the bypass.
6 Subject experienced left arm claudication on day 30, LSA was intentionally (completely) covered during initial procedure. Subject underwent left carotid to subclavian bypass on day 103 and the event has since resolved.
7 Subject developed a right groin hematoma on the day of the index procedure. The event resolved without treatment four (4) days post procedure.
8 Subject developed erythema at right groin incision on day four (4) from the index procedure. The site reported this event to be related to the procedure. This event resolved the following day with medication.
To assess the effectiveness of the Valiant thoracic stent graft, the RESCUE trial collected information on the success of device delivery and deployment. Information was also collected on technical observations including endoleaks, stent graft kinking, stent graft twisting, misaligned deployment, stent graft fracture, loss of stent graft integrity, loss of stent graft patency, migration and if the traumatic injury was covered by the stent. In addition, the following device assessments were collected by the sites and verified by the independent core laboratory:
- Loss of stent graft patency
- Total length of the stented segment
- Stent graft migration
- Presence and type of endoleaks
As shown in the tables below, after gaining vessel access at procedure, the investigators reported that the device was delivered and deployed successfully in all 50 subjects. Delivery and deployment was documented by investigators as either successful or not successful on the case report forms. There were no Type I or Type III endoleaks reported in this study population. There were two (2) subjects reported to have a Type II endoleak at the end of procedure by the site, both of these endoleaks resolved without treatment by the 1-month visit. No technical observations were reported from the 1-month follow-up CTA/MRA images. The stent graft integrity was maintained in 100% of the cases. There were no reports of stent graft twisting, kinking, or fracture, and all stent grafts remained patent as reported by the sites and the core lab. There were no occurrences of Unanticipated Adverse Device Effects (UADEs) in this trial.
|Secondary Efficacy Endpoint||% (m/n)|
|Successful Delivery and Deployment of the Stent Graft at index procedure||100.0% (50/50)|
m = number of subjects in category, n = number of subjects enrolled in this study.
Site and CEC Adjudicated Reported Table.
There were no cases of endovascular re-intervention or conversion to open surgery reported. There was one (1) subject within 30-days and two (2) subjects between 31 and 365 days that required LSA bypass to correct left arm ischemia. These events are captured under the ‘Other’ category in the table below.
|Secondary Procedure||0 to 30 Days % (m/n) a||31 to 365 Days % (m/n) a||366 to 731 Days % (m/n) a||732 to 1096 Days % (m/n) a||1097 to 1461 Days % (m/n) a||1462 to 1826 Days % (m/n) a|
|Conversion to Open Repair||0.0% (0/50)||0.0% (0/43)||0.0% (0/11)||N/A||N/A||N/A|
|Additional Endovascular Device Placed||0.0% (0/50)||0.0% (0/43)||0.0% (0/11)||N/A||N/A||N/A|
|Otherb||2.0% (1/50)||4.7% (2/43)||0.0% (0/11)||N/A||N/A||N/A|
a m = number of subjects in category, n = number of subjects with study stent implanted who experienced an event or who were followed at least until the lower endpoint of the interval. For example, for column '0-30 Days', '31-365 Days', '366-731 Days', '732-1096 Days', '1097-1461 Days' and '1462-1826 Days', a subject had to be followed respectively for at least 0 day, 31 days, 366 days, 732 days, 1097 days and 1462 days in order to be included in the denominator, unless he/she experienced an event in the corresponding interval.
b One subject had peripheral ischemia on day seven, LSA was intentionally (partially) covered during initial procedure. Subject underwent a left carotid to subclavian bypass on day eight and the ischemia resolved the next day. Another subject experienced left arm claudication on day 30, LSA was intentionally (completely) covered during initial procedure. Subject underwent left carotid to subclavian bypass on day 103 and the event has since resolved. A third subject experienced peripheral arm ischemia on day 36. On that same day a left carotid-to-subclavian bypass procedure was performed and the peripheral arm ischemia was resolved on the day of the procedure.
Valiant Thoracic Stent Graft with the Captivia Delivery System - Instructions for Use © 2014