RecruitingNCT06270537

Post-market Clinical Trial of the Dominus® Stent-Graft

Multicenter Study Collecting Post-market Clinical Data on the Dominus® Stent-Graft for Treating Thoracic Aortic Diseases


Sponsor

Braile Biomedica Ind. Com. e Repr. Ltda.

Enrollment

100 participants

Start Date

Oct 24, 2023

Study Type

OBSERVATIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria2

  • Patient currently participating in another clinical study of drug or medical device;
  • Life expectancy less than 12 months.

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Interventions

DEVICEStent-Graft Dominus® Endoprosthesis

Placement of the Dominus® Stent-Graft for endovascular repair of diseases of the Thoracic Aorta


Locations(3)

Hospital Evangélico de Vila Velha

Vila Velha, Espírito Santo, Brazil

Hospital Nossa Senhora da Conceição

Porto Alegre, Rio Grande do Sul, Brazil

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

Ribeirão Preto, São Paulo, Brazil

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NCT06270537


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