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

Thoracic Aortic Dissection Clinical Trial

— DominusPMCF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06270537
• Other study ID #: Dominus PMCF
• Status: Recruiting
• Start date: October 24, 2023
• Est. completion date: February 28, 2029

Study information

• Verified date: February 2024
• Source: Braile Biomedica Ind. Com. e Repr. Ltda.
• Contact: Glaucia Basso
• Phone: +55 (17) 2136-7005
• Email: glaucia.basso[@]braile.com.br
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 28, 2029
• Est. primary completion date: July 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Diseases
• Aortic Dissection
• Thoracic Aortic Dissection

Intervention

Device:
• Stent-Graft Dominus® Endoprosthesis
Placement of the Dominus® Stent-Graft for endovascular repair of diseases of the Thoracic Aorta

Locations

Country	Name	City	State
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	Hospital Evangélico de Vila Velha	Vila Velha	Espirito Santo

Sponsors (1)

Lead Sponsor	Collaborator
Braile Biomedica Ind. Com. e Repr. Ltda.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Device Success	Rate of successful introduction, navigation, and deployment of the device at the intended site	Intraoperative
Secondary	Absence of endoprosthesis fracture	rate of absence of endoprosthesis fracture	1 month and 1 year
Secondary	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.	At the end of surgery/procedure, 1 month, 6 month, 1, 2, 3, 4 and 5 years
Secondary	Reintervention-free	Reintervention-free rate, defined as the absence of open surgical and/or endovascular reintervention	At the end of surgery/procedure, 1 month, 6 month, 1, 2, 3, 4 and 5 years
Secondary	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	At the end of surgery/procedure, 1 month, 6 month, 1, 2, 3, 4 and 5 years