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A Descending Thoracic Aneurysm is a bulge in the aorta. The aorta is a large blood vessel that carries blood away from your heart to organs in the rest of your body. Your aneurysm is caused by a weakening in the artery wall. If left untreated, this bulge may continue to grow larger and may ultimately rupture (break open) or extend in size to seriously affect other major arteries in the area. In this Research Study a device will be placed inside your aorta to block the weakened part of the artery wall from the circulatory system. Information will be collected on the performance for the device for 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Talent Thoracic Stent Graft | Device | TEVAR |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Efficacy Endpoint: proportion of patients in the Test Group who have successful aneurysm treatment at the 12-month follow-up visit. | 12 months | |
| Primary Safety Endpoint: rate of "all cause" mortality of TAA repair with the Talent Thoracic Stent Graft against the literature control for open surgical repair within 1 year of follow-up. | 12 months |
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Talent Captivia Inclusion Criteria
Patient is at least 18 years of age.
Patient is a surgical or non-surgical candidate
Patient has a:
Subject's anatomy must meet all of the following anatomical criteria:
Thoracic aortic lesion is confirmed, at a minimum, by diagnostic contrast enhanced computerized tomography (CTA) with optional 3-D reconstruction, and/or contrast enhanced Magnetic Resonance Angiogram (MRA) obtained within the previous three (3) months prior to the implant procedure.
Subject or subject's legal representative understands and has signed an Informed Consent approved by the Sponsor and by the IRB for this study.
Patient must be able and willing to undergo follow-up imaging and examinations postoperatively up to 6 months.
Talent Captivia Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Mark Kaye, MD | Physician's Regional Medical Center | Principal Investigator |
| Phillip Allmendinger, MD | Hartford Hospital | Principal Investigator |
| Mark Bates, MD | CAMC Health System | Principal Investigator |
| Daniel Benckart, MD | West Penn Allegheny Health System | Principal Investigator |
| Paul Bove, MD | Corewell Health East | Principal Investigator |
| Thomas Bower, MD | Mayo Clinic | Principal Investigator |
| Alfio Carroccio, MD | Mt. Sinai School of Medicine | Principal Investigator |
| Neal Cayne, MD | NYU Vascular Associates | Principal Investigator |
| Frank Criado, MD | Union Memorial Hospital | Principal Investigator |
| Alan Matsumoto, MD | University of Virginia |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania Hospital | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D017545 | Aortic Aneurysm, Thoracic |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Principal Investigator |
| Mark Eskandari, MD | Northwestern Memorial Hospital | Principal Investigator |
| Ronald Fairman, MD | University of Pennsylvania | Principal Investigator |
| Mark Farber, MD | University of North Carolina | Principal Investigator |
| James McKinsey, MD | New York Presbyterian (Columbia & Cornell) | Principal Investigator |
| Mark Fillinger, MD | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| H. Edward Garrett, MD | Baptist Memorial Hospital | Principal Investigator |
| Marc Glickman, MD | Sentar Norfolk General | Principal Investigator |
| Kim Hodgson, MD | Memorial Medical Center | Principal Investigator |
| Matthew Jung, MD | Surgical Care Associates | Principal Investigator |
| Barry Katzen, MD | Baptist Health South Florida | Principal Investigator |
| Zvonimir Krajcer, MD | St. Luke's Episcopal Hospital-Houston | Principal Investigator |
| Christopher Kwolek, MD | Massachusetts General Hospital | Principal Investigator |
| Lowell Satler, MD | Medstar Health Research Institute | Principal Investigator |
| Anthony Lee, MD | University of Florida | Principal Investigator |
| Alan Lumsden, MD | Baylor College of Medicine | Principal Investigator |
| Sean Lyden, MD | Cleveland Clinic Foundation-Ohio | Principal Investigator |
| Richard McCann, MD | Duke University | Principal Investigator |
| Manish Mehta, MD | Vascular Group, PLLC | Principal Investigator |
| Mark Mewissen, MD | St. Luke's Vascular Center | Principal Investigator |
| Takao Ohki, MD | Montefiore Medical Center | Principal Investigator |
| Venkatesh Ramaiah, MD | Arizona Heart Institute | Principal Investigator |
| Robert Rhee, MD | Shadyside Hospital-UPMC | Principal Investigator |
| Timothy Roush, MD | Carolinas Medical Center | Principal Investigator |
| Gregoria Sicard, MD | Washington University School of Medicine | Principal Investigator |
| Cary Stowe, MD | AdventHealth | Principal Investigator |
| Jim Swischuk, MD | Saint Francis Hospital | Principal Investigator |
| Michael Tuchek, MD | Loyola University | Principal Investigator |
| Rodney White, MD | Harbor UCLA | Principal Investigator |
| David Williams, MD | University of Michigan | Principal Investigator |
| Christopher Zarins, MD | Stanford University | Principal Investigator |
| D001018 |
| Aortic Diseases |