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

NCT ID: NCT06270537

Last Updated: 2024-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-24

Study Completion Date

2029-02-28

Brief Summary

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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

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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

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Thoracic Aortic Dissection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Stent-Graft Dominus® Endoprosthesis

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Braile Biomedica Ind. Com. e Repr. Ltda.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edwaldo Joviliano

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Hospital Evangélico de Vila Velha

Vila Velha, Espírito Santo, Brazil

Site Status NOT_YET_RECRUITING

Hospital Nossa Senhora da Conceição

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

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

Ribeirão Preto, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Glaucia Basso

Role: CONTACT

+55 (17) 2136-7005

Facility Contacts

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Rodrigo Argenta

Role: primary

Eduardo A Silva

Role: primary

Ewaldo Joviliano

Role: primary

Other Identifiers

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Dominus PMCF

Identifier Type: -

Identifier Source: org_study_id

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