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| Name | Class |
|---|---|
| NAMSA | OTHER |
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DISSECT-N is a post-market registry designed to assess real-world safety and effectiveness of Valiant Navion Thoracic Stent Graft System in the treatment of thoracic aortic dissections in real world practice.
DISSECT-N is a prospective, observational, global, multi-center, post-market registry designed to assess real-world safety and effectiveness of Valiant Navion Thoracic Stent Graft System in the treatment of thoracic aortic dissections in real world practice.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valiant Navion Thoracic Stent Graft System | Device | Placement of the Valiant Navion for endovascular repair of a dissection in the thoracic aorta. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite safety and effectiveness | Safety: Major Adverse Events (MAEs) Defined as: all-cause mortality (ACM), retrograde type A dissection (RTAD), aortic rupture, permanent paraplegia and paraparesis, stent induced new entry tear, conversion to open repair, disabling stroke, and non-preexisting renal failure. Effectiveness: Technical success defined as ability to advance, deploy and position the Valiant Navion Thoracic Stent Graft at target site with successful coverage and sealing of the proximal entry tear and removal of the delivery system. The primary endpoint is a dichotomous study outcome and a composite endpoint. A subject who has technical success and no MAE reported within 1-month will be considered a success. | 1-month post index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Aortic remodeling | Rate of aortic remodeling based on follow-up imaging. | 1-month, 1, 2 and 3 years |
| Access related complications | Rate of access related complications as proportion of evaluable patients. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population shall include all subjects diagnosed with a dissection of the thoracic aorta who have been treated, or are intended to be treated, with the Valiant Navion.
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| Name | Affiliation | Role |
|---|---|---|
| Ross Milner, MD | The University of Chicago Medicine & Biological Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Hospital | Birmingham | Alabama | 35233 | United States | ||
| University of Florida Health Shands Hospital |
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| peri-operative |
| Stent induced entry tear | Rate of stent induced entry tear as proportion of evaluable patients. | 1, 2 and 3 years |
| Stent graft migration | Rate of stent graft migration (>10mm) as proportion of evaluable patients. | 1, 2 and 3 years |
| Stent graft integrity | Rate of each type of loss of stent graft integrity (kink, twist, fracture, occlusion, or stenosis) as a proportion of evaluable patients based on follow-up imaging. | 1-month, 1, 2 and 3 years |
| Disease progression | Extension of dissection. | 1,2 and 3 years |
| Transient Ischemic Attack (TIA)/minor strokes | Rate of TIA/minor stroke as a proportion of evaluable patients. | 1-month |
| Transient spinal cord ischemia | Rate of transient spinal cord ischemia as a proportion of evaluable patients. | 1-month, 1, 2 and 3 years |
| Unplanned secondary procedures | Rate of unplanned secondary procedures. | 1, 2 and 3 years |
| False lumen perfusion | Rate of each type of false lumen perfusion based on follow-up imaging. | 1-month, 1, 2 and 3 years |
| Endoleaks | Rate of each type of endoleak based on follow-up imaging. | 1-month, 1, 2 and 3 years |
| Major adverse events | Major adverse events defined as:
| 1, 2 and 3 years |
| Gainesville |
| Florida |
| 32608 |
| United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| University of Michigan Health System - University Hospital | Ann Arbor | Michigan | 48109 | United States |
| Albany Medical Center | Albany | New York | 12208 | United States |
| Northwell Health Lenox Hill Hospital | New York | New York | 10075 | United States |
| Atrium Health's Carolinas Medical Center | Charlotte | North Carolina | 28203 | United States |
| UPMC Pinnacle Harrisburg Campus | Harrisburg | Pennsylvania | 17101 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Baylor Plano | Plano | Texas | 75903 | United States |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | United States |
| Rigshospitalet | Copenhagen | 2100 | Denmark |
| General Hospital of Athens, Evaggelismos | Athens | 10676 | Greece |
| Ospedale San Raffaele - Milano | Milan | 20132 | Italy |
| National Cerebral and Cardiovascular Center | Suita | Osaka | 564-8565 | Japan |
| Keio University Hospital | Tokyo | 108-8345 | Japan |
| St. Antonius Ziekenhuis | Nieuwegein | 3435 CM | Netherlands |
| Auckland City Hospital | Grafton | 1023 | New Zealand |
| Narodny Ustav Srdcovych a Cievnych Chorob, A.S. | Bratislava | 83348 | Slovakia |
| Severance Hospital | Seoul | 03722 | South Korea |
| Songklanagarind Hospital | Hat Yai | Changwat Songkhla | 90110 | Thailand |
| ID | Term |
|---|---|
| D000094629 | Dissection, Thoracic Aorta |
| ID | Term |
|---|---|
| D000784 | Aortic Dissection |
| D000094665 | Dissection, Blood Vessel |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000094683 | Acute Aortic Syndrome |
| D001018 | Aortic Diseases |
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