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

NCT06270537 | Recruiting

• 1 other identifier: Dominus PMCF
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Thoracic Aortic Dissection

Keywords

Aneurysm; Acute Aortic Syndrome; Aortic Dissection; Aortic Diseases; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• 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).

  1 month post index procedure

Secondary Outcomes (5)

• Device Success

  Intraoperative

• Absence of endoprosthesis fracture

  1 month and 1 year

• Endoleak

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

• Reintervention-free

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

• Adverse Events

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

Interventions

Stent-Graft Dominus® Endoprosthesis DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 18 Years and older (Adult, Older Adult )
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Braile Biomedica Ind. Com. e Repr. Ltda.: lead

Study Sites (3)

Hospital Evangélico de Vila Velha

Vila Velha, Espírito Santo, 29118-060, Brazil

NOT YET RECRUITING

Hospital Nossa Senhora da Conceição

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

RECRUITING

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

Ribeirão Preto, São Paulo, 14048-900, Brazil

RECRUITING

MeSH Terms

Conditions

Dissection, Thoracic Aorta; Aneurysm; Acute Aortic Syndrome; Aortic Dissection; Aortic Diseases; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Vascular Diseases

Study Officials

• Edwaldo Joviliano

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Glaucia Basso

CONTACT

+55 (17) 2136-7005; glaucia.basso@braile.com.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: February 21, 2024
• Study Start: October 24, 2023
• Primary Completion: July 30, 2025
• Study Completion (Estimated): February 28, 2029
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (3)