Proven clinical track record — five-year outcomes in all descending thoracic aortic pathologies.
Review the results with Valiant Captivia clinical trials:
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
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 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/stable3
77%
(13/17) False lumen diameter decrease/stable3
100%
(18/18) Partial/complete false lumen thrombosis3
100%
(50/50) Coverage of primary entry tear2
The Valiant™ Captivia™ system effectively treated acute complicated Type B aortic dissections with positive aortic remodeling through five years.
The RESCUE trial 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 demonstrated 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
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.
In this educational video series, leading specialists discuss their clinical experiences treating aortic dissection.
We wish to thank the following surgeons for sharing their answers to questions about dissection treatment:
Treating Type B Aortic Dissection Video - (05:59)
Watch this video to hear physicians discuss when they would treat a Type B aortic dissection endovascularly.
When to Treat with TEVAR Video - (03:00)
Watch this video to hear physicians discuss their thoughts on when the appropriate time is to treat a Type B dissection with TEVAR.
Treating Acute Uncomplicated Dissection Video - (01:46)
Watch this video to hear physicians answer the question: How would you treat an acute uncomplicated dissection?
Treating Chronic Dissection Video - (04:46)
Watch this video to hear physicians discuss their approach to treat patients with chronic dissection.
Treating Retrograde Type A Dissection Video - (03:08)
Watch this video and hear physicians discuss their concerns with retrograde Type A dissection.
Surveillance Protocol Video - (02:14)
Watch this video to hear Dr. Bradley Taylor describe his typical surveillance protocol for the Type B dissection patients he has treated.
Dr. Bradley S. Taylor Graft Oversizing Video - (02:07)
Watch this video to hear surgeons discuss how they oversize stent grafts to treat dissection patients.
Dr. Rodney A. White Length of Coverage Video - (04:11)
Watch this video and hear surgeons share their recommendation on length of coverage for acute and chronic dissection regarding TEVAR.
Outreach to Referring Physicians Video - (02:55)
Watch this video to hear surgeons share their thoughts on referral outreach for aortic dissection.
Dissection Awareness for Referring Physicians Video - (03:50)
Watch this video and hear surgeons discuss important factors to help increase dissection awareness with referring physicians.
† 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.
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