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NCT Number: NCT06270537

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

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

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Key information

Conditions

Thoracic Aortic Dissection Acute Aortic Syndrome Aneurysm Aortic Diseases Aortic Dissection Cardiovascular Diseases Dissection, Blood Vessel Dissection, Thoracic Aorta Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Evangélico de Vila Velha, Vila Velha, Espírito Santo, Brazil

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 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.

Exclusion criteria

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

Treatment and study plan

Stent-Graft Dominus® Endoprosthesis

Device

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

Primary outcomes

  1. Early occurrence of adverse events (Safety Outcome)

    Time frame: 1 month post index procedure

    Early rate Major Adverse Events (MAEs), including all-cause mortality, acute myocardial infarction (AMI), stroke, permanent paraplegia, and recent-onset renal failure (requiring dialysis).

Secondary outcomes

  1. Device Success

    Time frame: Intraoperative

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

  2. Absence of endoprosthesis fracture

    Time frame: 1 month and 1 year

    rate of absence of endoprosthesis fracture

  3. Endoleak

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

    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.

  4. Reintervention-free

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

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

  5. Adverse Events

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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Glaucia Basso

CONTACT

[email protected]

+55 (17) 2136-7005

Sponsors and collaborators

Lead sponsor

Braile Biomedica Ind. Com. e Repr. Ltda.

Industry

Registry information

Official study title

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

Acronym: DominusPMCF

Important dates

Study start
2023
Primary completion
2025
Study completion
2029
First posted
Feb 21, 2024
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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