5 years clinical outcome in all descending thoracic aortic pathologies: TAA, PAU, BTAI Valiant™ Thoracic Stent Graft with the Captivia™ Delivery System

Proven clinical track record — 5-year outcomes in all descending thoracic aortic pathologies. 

Review the results with Valiant™ Captivia™ clinical trials:  

• VALOR II
• Dissection
• RESCUE

VALOR II Valiant™ thoracic stent graft system pivotal study

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.

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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.

Freedom from dissection-related mortality

The Valiant Captivia system effectively treated acute complicated Type B aortic dissections with positive aortic remodeling through five years.

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Rescue Trial

The RESCUE trial¹ 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.

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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