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Real-world clinical trial evidence post-market, evaluating the safety and efficacy of the Dominus® StentGraft Endoprosthesis in treating thoracic aortic diseases, following the Instructions for Use
The multicenter study aims to collect post-market clinical data on the Dominus® Stent-Graft in the treatment of thoracic aortic diseases. With the goal of assessing safety and efficacy, the prospective follow-up study will include 100 patients undergoing Endovascular Treatment of Thoracic Aortic Diseases, following the product's Instructions for Use
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stent-Graft Dominus® Endoprosthesis | Device | Placement of the Dominus® Stent-Graft for endovascular repair of diseases of the Thoracic Aorta |
| Measure | Description | Time Frame |
|---|---|---|
| Early occurrence of adverse events (Safety Outcome) | Early rate Major Adverse Events (MAEs), including all-cause mortality, acute myocardial infarction (AMI), stroke, permanent paraplegia, and recent-onset renal failure (requiring dialysis). | 1 month post index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Device Success | Rate of successful introduction, navigation, and deployment of the device at the intended site | Intraoperative |
| Absence of endoprosthesis fracture | rate of absence of endoprosthesis fracture |
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Inclusion Criteria:
Exclusion Criteria:
18 Years and older (Adult, Older Adult )
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Patients with Thoracic Aortic Disease treated with the Dominus® Stent-Graft Endoprosthesis.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Glaucia Basso | Contact | +55 (17) 2136-7005 | glaucia.basso@braile.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Edwaldo Joviliano | Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Evangélico de Vila Velha | Not yet recruiting | Vila Velha | Espírito Santo | 29118-060 | Brazil |
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| ID | Term |
|---|---|
| D000094629 | Dissection, Thoracic Aorta |
| D000783 | Aneurysm |
| D000094683 | Acute Aortic Syndrome |
| D000784 | Aortic Dissection |
| D001018 | Aortic Diseases |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D000094665 | Dissection, Blood Vessel |
| D014652 | Vascular Diseases |
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| 1 month and 1 year |
| Endoleak | Rate of persistence of blood flow outside the lumen of the endoluminal graft (based on follow-up imaging). Primary endoleaks occur within 30 days post-procedure, and secondary (or late) endoleaks are detected after 30 days and subsequent to previous negative images. | At the end of surgery/procedure, 1 month, 6 month, 1, 2, 3, 4 and 5 years |
| Reintervention-free | Reintervention-free rate, defined as the absence of open surgical and/or endovascular reintervention | At the end of surgery/procedure, 1 month, 6 month, 1, 2, 3, 4 and 5 years |
| Adverse Events | Adverse events defined as:
| At the end of surgery/procedure, 1 month, 6 month, 1, 2, 3, 4 and 5 years |
| Hospital Nossa Senhora da Conceição | Recruiting | Porto Alegre | Rio Grande do Sul | 91350-200 | Brazil |
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| Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo | Recruiting | Ribeirão Preto | São Paulo | 14048-900 | Brazil |
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