Post-market Clinical Trial of the Dominus® Stent-Graft
ConditionThoracic Aortic Dissection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBraile Biomedica Ind. Com. e Repr. Ltda.
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years of age or older;
Patients treated with the Dominus® Stent-Graft Endoprosthesis in accordance with its Instructions for Use;
Patient available for appropriate follow-up times for the study duration;
Informed patient about the nature of the study, agreeing to its provisions, and signing the informed consent.
Disqualifiers
Patient currently participating in another clinical study of drug or medical device;
Life expectancy less than 12 months.
Trial population
Patients with Thoracic Aortic Disease treated with the Dominus® Stent-Graft Endoprosthesis.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Stent-Graft Dominus® Endoprosthesis
DevicePlacement of the Dominus® Stent-Graft for endovascular repair of diseases of the Thoracic Aorta
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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 procedureSecondary outcomes
1
Device Success
Rate of successful introduction, navigation, and deployment of the device at the intended site
Time frame
Intraoperative2
Absence of endoprosthesis fracture
rate of absence of endoprosthesis fracture
Time frame
1 month and 1 year3
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 years4
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 yearsSponsors and contacts
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Source ClinicalTrials.gov