Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00604799 | VALOR: The Talent Thoracic Stent Graft System Clinical Study | PHASE2 | COMPLETED | 379 | — | — | Jul 1, 2003 | Jun 1, 2011 | Nov 2, 2021 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Test (Enrollment Completed) | ACTIVE_COMPARATOR | Patients diagnosed with a TAA of degenerative etiology that are considered candidates for open surgical repair whom are low to moderate risk (0, 1, \& 2) per the modified SVS/AAVS criteria who meet inclusion/exclusion criteria. The aneurysm must be at least 20 mm distal to the left common carotid artery \& 20 mm proximal to the origin of the celiac artery. |
| Registry (Enrollment Completed) | OTHER | Surgical candidates of low to moderate risk (SVS 0, 1, 2) that meet the Registry Inclusion/Exclusion criteria. |
| High Risk (Enrollment Completed) | OTHER | Patients that meet one or more of the following: * High Risk (SVS 3) * Non-surgical candidates not associated with SVS scoring * Traumatic thoracic injuries |
| Talent Captivia (Recruiting) | OTHER | Patients diagnosed with a TAA of degenerative etiology that are considered candidates for open surgical repair who meet inclusion/exclusion criteria. |
| Name | Type | Description |
|---|---|---|
| Talent Thoracic Stent Graft | DEVICE | TEVAR |
Talent Captivia Inclusion Criteria 1. Patient is at least 18 years of age. 2. Patient is a surgical or non-surgical candidate 3. Patient has a: 1. Fusiform focal TAA AND / OR 2. Focal saccular TAA or penetrating atherosclerotic ulcer. 4. Subject's anatomy must meet all of the following anato...