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| ID | Type | Description | Link |
|---|---|---|---|
| 370010, TXD |
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| Name | Class |
|---|---|
| Cook Group Incorporated | INDUSTRY |
| MED Institute, Incorporated | INDUSTRY |
| William Cook Australia | INDUSTRY |
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The purpose of this study is to evaluate the safety and effectiveness performance of the Zenith® Dissection Endovascular System in the treatment of aortic dissections involving the descending thoracic aorta.
The Zenith® Thoracic Dissection Study is a clinical trial to study the safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of dissections (length-wise tear) of the descending thoracic aorta. The Zenith® Dissection Endovascular System is comprised of the Zenith TX2® TAA Endovascular Graft and the Zenith® Dissection Endovascular Stent. Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the graft and the dissection stent into place in the aorta.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | Endovascular Repair |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zenith® Dissection Endovascular System | Device | The Zenith® Thoracic Dissection Study is a clinical trial to study the safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of dissections (length-wise tear) of the descending thoracic aorta. The Zenith® Dissection Endovascular System is comprised of the Zenith TX2® TAA Endovascular Graft and the Zenith® Dissection Endovascular Stent. Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the graft and the dissection stent into place in the aorta. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint is survival at 30 days | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Measure: Clinical utility, incidence and rate of adverse events, mortality, factors related to morbidity | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Lombardi, MD | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Vincent's Hospital Melbourne | Melbourne | VIC 3065 | Australia | |||
| St. Anne's Universtiy Hospital Brno |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31147139 | Derived | Lombardi JV, Cambria RP, Nienaber CA, Chiesa R, Mossop P, Haulon S, Zhou Q; STABLE I Investigators. Five-year results from the Study of Thoracic Aortic Type B Dissection Using Endoluminal Repair (STABLE I) study of endovascular treatment of complicated type B aortic dissection using a composite device design. J Vasc Surg. 2019 Oct;70(4):1072-1081.e2. doi: 10.1016/j.jvs.2019.01.089. Epub 2019 May 28. |
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|
| Endovascular Repair | Device | Endovascular Repair |
|
| Brno |
| 656 91 |
| Czechia |
| CHRU de Lille | Lille | Cedex | 59037 | France |
| Hannover Medical School | Hanover | 30625 | Germany |
| Heart Center Leipzig / Park Hospital | Leipzig | 04289 | Germany |
| Clinic of Internal Medicine, University Hospital Rostock | Rostock | 18057 | Germany |
| Hospital San Raffaele | Milan | 20129 | Italy |
| IRCCS Policlinico San Matteo | Pavia | 27100 | Italy |
| ID | Term |
|---|---|
| D000094682 | Endovascular Aneurysm Repair |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019917 | Blood Vessel Prosthesis Implantation |
| D058017 | Vascular Grafting |
| D019060 | Minimally Invasive Surgical Procedures |
| D019919 | Prosthesis Implantation |
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