An observational study in Thoracic Aortic Dissection, sponsored by Braile Biomedica Ind. Com. e Repr. Ltda.. Recruiting at 3 sites in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-22.
Sponsored by Braile Biomedica Ind. Com. e Repr. Ltda. · Observational
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
30 studies on the registry are indexed under Dissection, Thoracic Aorta; 10 are open to participants now.
This study's planned enrollment of 100 is close to the median of 102 across 17 observational studies indexed under Dissection, Thoracic Aorta.
Browse Dissection, Thoracic Aorta studies →Braile Biomedica Ind. Com. e Repr. Ltda. is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with Thoracic Aortic Disease treated with the Dominus® Stent-Graft Endoprosthesis.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Placement of the Dominus® Stent-Graft for endovascular repair of diseases of the Thoracic Aorta
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).
Time frame: 1 month post index procedure
Device Success
Rate of successful introduction, navigation, and deployment of the device at the intended site
Time frame: Intraoperative
Absence of endoprosthesis fracture
rate of absence of endoprosthesis fracture
Time frame: 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.
Time frame: 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
Time frame: At the end of surgery/procedure, 1 month, 6 month, 1, 2, 3, 4 and 5 years
Adverse Events
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
Time frame: At the end of surgery/procedure, 1 month, 6 month, 1, 2, 3, 4 and 5 years
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2023 (actual). Primary completion is estimated for Jul 2025, 21 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Braile Biomedica Ind. Com. e Repr. Ltda.