2024 annual physician
clinical update
Valiant™ thoracic stent graft with Captivia™ delivery system
Clinical data
Five-year outcomes in all descending thoracic aortic pathologies
Proven clinical track record — five-year outcomes in all descending thoracic aortic pathologies.
Review the results with Valiant™ Captivia™ clinical trials:
VALOR II Valiant Thoracic Stent Graft System Pivotal Study
Five-year outcomes
The VALOR II Valiant Thoracic Stent Graft System Pivotal Study1 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 descending thoracic aorta.
0.0%
(0/60) types I and III
endoleaks
1.7%
(1/60) type II
endoleak
89.3%
(50/56) sac diameter
decreasing or stable
Dissection Trial
The Medtronic Dissection Trial2 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 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% (4/50).*†‡ Four (4) subjects died within 30 days of the index procedure.
Dissection Trial2
Five-year outcomes3
The Medtronic Dissection Trial2 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 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% (4/50).†,‡,§ Four (4) subjects died within 30 days of the index procedure.
The Valiant™ Captivia™ thoracic stent graft system effectively treated acute complicated type B aortic dissections with positive aortic remodeling through five years.
94%
(16/17) True lumen diameter increase/stable
77%
(13/17) False lumen diameter decrease/stable
100%
(18/18) Partial/complete false lumen thrombosis
100%
(50/50) Coverage of primary entry tear2
Freedom from dissection-related mortality
The Valiant™ Captivia™ system effectively treated acute complicated type B aortic dissections with positive aortic remodeling through five years.
RESCUE Trial
Five-year outcomes4
The RESCUE trial4 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. Four subjects died within 30 days of the index procedure. This result demonstrates a 30-day all-cause mortality rate of 8.0% (4/50) for BTAI subjects treated with the Valiant™ thoracic stent graft.
Excellent five-year outcomes and durable exclusion of BTAI
100%
(50/50) Device access, delivery,
and deployment
0%
Types I and III endoleaks/stroke/RTAD
70%
(35/50) Aortic injury grade III severity or higher
Device delivery success in the RESCUE Trial
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
There were no type I or type III endoleaks reported in this study population. There were two 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 one-month visit. No technical observations were reported from the one-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.
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† 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.
‡ 95% UCL 17.4%. 95% Upper Confidence Limit (UCL) was calculated using an exact method based on the binomial distribution.
§ Based on CEC-adjudicated data.
1. Conrad MF, Tuchek J, Freezor R, et al. Results of the VALOR II trial of the Medtronic Valiant Thoracic Stent Graft. J Vasc Surg. 2017;66:335–342. doi: 10.1016/j.jvs.2016.12.136.
2. Bavaria JE, Brinkman WT, Hughes GC, et al. Outcomes of thoracic endovascular aortic repair in acute type B aortic dissection: results from the Valiant United States investigational device exemption study. Ann Thorac Surg. 2015;100(3):802–808. doi: 10.1016/j.athoracsur.2015.03.108.
3. Bavaria JE, Brinkman WT, Hughes GC, et al. Five-year outcomes of endovascular repair of complicated acute type B aortic dissections. J Thorac Cardiovasc Surg. 2022;163(2):539-548.e2. doi: 10.1016/j.jtcvs.2020.03.162.
4. Patel HJ, Azizzadeh A, Matsumoto AH, et al. Five-year outcomes from the United States Pivotal Trial of Valiant Captivia stent graft for blunt aortic injury. Ann Thorac Surg. 2020;110(3):815–820. doi: 10.1016/j.athoracsur.2019.12.028.