Thoracic Aortic DissectionDominusPMCFNCT06270537
Post-market Clinical Trial of the Dominus® Stent-Graft
An observational study of Thoracic Aortic Dissection, run by Braile Biomedica Ind. Com. e Repr. Ltda. at 3 sites in Brazil.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Aortic Dissection
- What is being tested?
- Stent-Graft Dominus® Endoprosthesis
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 3 sitesBrazil
- Study dates
- 24 Oct 2023to 28 Feb 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Thoracic Aortic Disease treated with the Dominus® Stent-Graft Endoprosthesis.
Who may be able to join
- 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.
Who cannot join
- Patient currently participating in another clinical study of drug or medical device;
- Life expectancy less than 12 months.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil3 sites, 3 recruiting
- Recruiting
Hospital Nossa Senhora da Conceição
Porto Alegre, Rio Grande do Sul, 91350-200
Eduardo A Silva
- Recruiting
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Ribeirão Preto, São Paulo, 14048-900
Ewaldo Joviliano
- Not yet recruiting
Hospital Evangélico de Vila Velha
Vila Velha, Espírito Santo, 29118-060
Rodrigo Argenta
About this study
Official title: Multicenter Study Collecting Post-market Clinical Data on the Dominus® Stent-Graft for Treating Thoracic Aortic Diseases
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
Read the 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
- Conditions
- Thoracic Aortic Dissection
- Being tested
- Stent-Graft Dominus® Endoprosthesis
- Keywords
- Aneurysm, Acute Aortic Syndrome, Aortic Dissection, Aortic Diseases, Cardiovascular Diseases
- Medical subject headings
- Dissection, Thoracic Aorta, Aneurysm, Acute Aortic Syndrome, Aortic Dissection, Aortic Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stent-Graft Dominus® EndoprosthesisDevice
Placement of the Dominus® Stent-Graft for endovascular repair of diseases of the Thoracic Aorta
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 month post index procedure
Secondary outcomes (5)
Device Success
Rate of successful introduction, navigation, and deployment of the device at the intended site
Measured: Intraoperative
Absence of endoprosthesis fracture
rate of absence of endoprosthesis fracture
Measured: 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.
Measured: 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
Measured: 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
Measured: At the end of surgery/procedure, 1 month, 6 month, 1, 2, 3, 4 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start24 Oct 2023
- Primary completion30 Jul 2025 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Aortic DissectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edwaldo Joviliano, Principal investigator, Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270537
- Sponsor's protocol ID
- Dominus PMCF
- Acronym
- DominusPMCF
- Status last verified
- Aug 2024
- First submitted
- 9 Jan 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study Collecting Post-market Clinical Data on the Dominus® Stent-Graft for Treating Thoracic Aortic Diseases
- ClinicalTrials.gov ID
- NCT06270537
- Acronym / sponsor ID
- DominusPMCF / Dominus PMCF
- Conditions
- Thoracic Aortic Dissection
- Keywords
- Aneurysm, Acute Aortic Syndrome, Aortic Dissection, Aortic Diseases, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.Industry (pharma, biotech, devices)
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Thoracic Aortic Disease treated with the Dominus® Stent-Graft Endoprosthesis.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Patient currently participating in another clinical study of drug or medical device;
- Life expectancy less than 12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stent-Graft Dominus® EndoprosthesisPlacement of the Dominus® Stent-Graft for endovascular repair of diseases of the Thoracic Aorta | Device | – |
Primary outcome
Early occurrence of adverse events (Safety Outcome)
Time frame: 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).
5 secondary outcomes
Device Success
Time frame: Intraoperative
Absence of endoprosthesis fracture
Time frame: 1 month and 1 year
Endoleak
Time frame: At the end of surgery/procedure, 1 month, 6 month, 1, 2, 3, 4 and 5 years
Reintervention-free
Time frame: At the end of surgery/procedure, 1 month, 6 month, 1, 2, 3, 4 and 5 years
Adverse Events
Time frame: At the end of surgery/procedure, 1 month, 6 month, 1, 2, 3, 4 and 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Thoracic Aortic Dissection
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GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
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Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
Recruiting
Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA
Aortic Arch Aneurysm, Aortic Arch Dissection
Active, not recruitingObservational study
Pulmonary Complications Following TEVAR
Aortic Aneurysm and Dissection, Thoracic Endovascular Aortic Repair
Recruiting
MBA Early Feasibility Study
Thoracic Aortic Aneurysm, Penetrating Aortic Ulcers (PAUs)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Edwaldo Joviliano principal investigator
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Aortic Dissection, run by Braile Biomedica Ind. Com. e Repr. Ltda. at 3 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Glaucia Basso (+55 (17) 2136-7005, glaucia.basso@braile.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early occurrence of adverse events (Safety Outcome) (time frame: 1 month post index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.