Post-market Clinical Trial of the Dominus® Stent-Graft
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Stent-Graft Dominus® Endoprosthesis.
- Who it may be relevant to
- Registry conditions: Thoracic Aortic Dissection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Multicenter Study Collecting Post-market Clinical Data on the Dominus® Stent-Graft for Treating Thoracic Aortic Diseases
Overview
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
- Device Stent-Graft Dominus® Endoprosthesis
Placement of the Dominus® Stent-Graft for endovascular repair of diseases of the Thoracic Aorta
Primary outcome measures
- Early occurrence of adverse events (Safety Outcome) [Time frame: 1 month post index procedure]
Secondary outcome measures (5)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Patient currently participating in another clinical study of drug or medical device;
- Life expectancy less than 12 months.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Brazil · 3 centers
- Hospital Evangélico de Vila Velha — Vila Velha
- Hospital Nossa Senhora da Conceição — Porto Alegre
- Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Pa — Ribeirão Preto
Identifiers
NCT: NCT06270537 · Dominus PMCF