Clinical Outcomes
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 ENDPOINTS | AT 12 MONTHS |
|---|---|
| Successful aneurysm treatment* | 97.4% (112/115 patients) |
| Aneurysm-related mortality | 3.3% (5/151 patients) |
| Aneurysym rupture | 0% (0/154 patients) |
| Conversion to open surgical repair | 0% (0/154 patients) |
| Proximal stent graft migration > 10mm proximally | 0% (0/105 patients) |
| Proximal stent graft migration > 10mm distally | 0% (0/105 patients) |
| Distal stent graft migration > 10mm proximally | 2.9% (3/105 patients)† |
| Distal stent graft migration > 10mm distally | 0% (1/105 patients) |
| Type I Endoleak | 3% (3/100 patients) |
| Type II Endoleak | 7% (7/100 patients) |
| Type III Endoleak | 1% (1/100 patients) |
| Type IV Endoleak | 0% (1/100 patients) |
| STUDY ENDPOINTS | AT 30 DAYS |
| Paraplegia | 0.6% (1/160 patients) |
| Paraparesls | 1.9% (3/160 patients) |
Source: Valiant Thoracic Stent Graft with the Captivia Delivery System Instructions for Use
* Successful aneurysm treatment was a composite endpoint that included the absence of:
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.
† None resulted in an adverse event or required intervention, and no subject experienced a loss of stent graft patency.
Valiant Captivia 2012 Clinical Update (PDF, 1.7 MB)
Valiant Captivia Registry Clinical Results
The purpose of the European Post Market Valiant Captivia Registry is to gather information regarding the long-term clinical performance of the Valiant thoracic stent graft with the Captivia delivery system in real-world practice.
| STUDY ENDPOINTS | AT 30 DAYS |
|---|---|
| Technical success** | 100% (50/50 patients) |
| Misaligned deployment | 0% (0/50 patients) |
| Graft perforation | 0% (0/50 patients) |
Source: Valiant Thoracic Stent Graft with the Captivia Delivery System Instructions for Use
** Technical success is defined as successful delivery and deployment of the stent graft (assessed intraoperatively) in the planned location with no unintentional coverage of the left subclavian artery, left common carotid artery, and/or brachiocephalic artery and with the removal of the delivery system.