Post-market Clinical Trial of the Dominus® Stent-Graft (DominusPMCF)

August 21, 2024 updated by: Braile Biomedica Ind. Com. e Repr. Ltda.

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Brazil
    • Espirito Santo
      • Vila Velha, Espirito Santo, Brazil, 29118-060
        • Not yet recruiting
        • Hospital Evangélico de Vila Velha
        • Contact:
          • Rodrigo Argenta
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 91350-200
        • Recruiting
        • Hospital Nossa Senhora da Conceicao
        • Contact:
          • Eduardo A Silva
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14048-900
        • Recruiting
        • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
        • Contact:
          • Ewaldo Joviliano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with Thoracic Aortic Disease treated with the Dominus® Stent-Graft Endoprosthesis.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
1 month post index procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Device Success
Time Frame: Intraoperative
Rate of successful introduction, navigation, and deployment of the device at the intended site
Intraoperative
Absence of endoprosthesis fracture
Time Frame: 1 month and 1 year
rate of absence of endoprosthesis fracture
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
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
Time Frame: 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
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

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
At the end of surgery/procedure, 1 month, 6 month, 1, 2, 3, 4 and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Braile Biomedica Ind. Com. e Repr. Ltda.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Edwaldo Joviliano, Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 24, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Dominus PMCF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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