Post-market Clinical Trial of the Dominus® Stent-Graft (DominusPMCF)

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

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

Study Overview

• Status: Recruiting
• Conditions: Thoracic Aortic Dissection
• Intervention / Treatment: Device: Stent-Graft Dominus® Endoprosthesis

Detailed 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

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Glaucia Basso; Phone Number: +55 (17) 2136-7005; Email: glaucia.basso@braile.com.br

Study Locations

• Brazil
  • Espirito Santo
    • Vila Velha, Espirito Santo, Brazil, 29118-060
      • Not yet recruiting
      • Hospital Evangélico de Vila Velha
      • Contact: Rodrigo Argenta
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 91350-200
      • Recruiting
      • Hospital Nossa Senhora da Conceicao
      • Contact: Eduardo A Silva
  • São Paulo
    • Ribeirão Preto, São Paulo, Brazil, 14048-900
      • Recruiting
      • Hospital Das Clinicas Da Faculdade De Medicina De Ribeirao Preto da Universidade de Sao Paulo
      • Contact: Ewaldo Joviliano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Success	Rate of successful introduction, navigation, and deployment of the device at the intended site	Intraoperative
Absence of endoprosthesis fracture	rate of absence of endoprosthesis fracture	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.	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	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	At the end of surgery/procedure, 1 month, 6 month, 1, 2, 3, 4 and 5 years

Collaborators and Investigators

• Sponsor: Braile Biomedica Ind. Com. e Repr. Ltda.
• Investigators: Principal Investigator: Edwaldo Joviliano, Hospital Das Clinicas Da Faculdade De Medicina De Ribeirao Preto da Universidade de Sao Paulo

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2023
• Primary Completion (Estimated): July 30, 2025
• Study Completion (Estimated): February 28, 2029

Study Registration Dates

• First Submitted: January 9, 2024
• First Submitted That Met QC Criteria: February 19, 2024
• First Posted (Actual): February 21, 2024

Study Record Updates

• Last Update Posted (Actual): August 22, 2024
• Last Update Submitted That Met QC Criteria: August 21, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Cardiovascular Diseases; Aneurysm; Aortic Dissection; Aortic Diseases; Acute Aortic Syndrome
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Dissection, Blood Vessel; Acute Aortic Syndrome; Aortic Diseases; Aortic Dissection; Dissection, Thoracic Aorta
• Other Study ID Numbers: Dominus PMCF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No