Thoracic Aortic Dissection
Conditions
Keywords
Aneurysm, Acute Aortic Syndrome, Aortic Dissection, Aortic Diseases, Cardiovascular Diseases
Brief summary
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
Detailed description
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
Interventions
DEVICEStent-Graft Dominus® Endoprosthesis
Placement of the Dominus® Stent-Graft for endovascular repair of diseases of the Thoracic Aorta
Sponsors
Braile Biomedica Ind. Com. e Repr. Ltda.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years of age or older; 2. Patients treated with the Dominus® Stent-Graft Endoprosthesis in accordance with its Instructions for Use; 3. Patient available for appropriate follow-up times for the study duration; 4. Informed patient about the nature of the study, agreeing to its provisions, and signing the informed consent.
Exclusion criteria
1. Patient currently participating in another clinical study of drug or medical device; 2. Life expectancy less than 12 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early occurrence of adverse events (Safety Outcome) | 1 month post index procedure | Early rate Major Adverse Events (MAEs), including all-cause mortality, acute myocardial infarction (AMI), stroke, permanent paraplegia, and recent-onset renal failure (requiring dialysis). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Success | Intraoperative | Rate of successful introduction, navigation, and deployment of the device at the intended site |
| Absence of endoprosthesis fracture | 1 month and 1 year | rate of absence of endoprosthesis fracture |
| Endoleak | At the end of surgery/procedure, 1 month, 6 month, 1, 2, 3, 4 and 5 years | 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. |
| Reintervention-free | At the end of surgery/procedure, 1 month, 6 month, 1, 2, 3, 4 and 5 years | Reintervention-free rate, defined as the absence of open surgical and/or endovascular reintervention |
| Adverse Events | At the end of surgery/procedure, 1 month, 6 month, 1, 2, 3, 4 and 5 years | Adverse events defined as: * All-cause mortality (ACM) * Retrograde type A dissection (RTAD) * Aortic rupture * Permanent paraplegia and paraparesis * Stent induced new entry tear * Conversation to open repair * Disabling stroke * Non-preexisting renal failure |
Countries
Brazil
Contacts
Primary ContactGlaucia Basso
Outcome results
None listed