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

Braile Biomedica Ind. Com. e Repr. Ltda.100 enrolled

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

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

OBSERVATIONAL

Enrollment

100

Conditions

Thoracic Aortic Dissection

Interventions

Stent-Graft Dominus® EndoprosthesisDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (3)

Hospital Evangélico de Vila Velha

Vila Velha, Espírito Santo, Brazil

NOT_YET_RECRUITING

Hospital Nossa Senhora da Conceição

Porto Alegre, Rio Grande do Sul, Brazil

RECRUITING

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

Ribeirão Preto, São Paulo, Brazil

RECRUITING

Outcomes

Primary Outcomes

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).

Time frame: 1 month post index procedure

Secondary Outcomes

Device Success

Rate of successful introduction, navigation, and deployment of the device at the intended site

Time frame: Intraoperative

Absence of endoprosthesis fracture

rate of absence of endoprosthesis fracture

Time frame: 1 month and 1 year

Endoleak

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.

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

Reintervention-free

Reintervention-free rate, defined as the absence of open surgical and/or endovascular reintervention

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

Adverse Events

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

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

Central Contacts

Glaucia Basso

CONTACT

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

Data from ClinicalTrials.gov

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