DISSECT-N Post Market Data Collection Registry

  • STATUS
    Recruiting
  • days left to enroll
    85
  • participants needed
    250
  • sponsor
    Medtronic Endovascular
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Updated on 16 February 2024
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Summary

DISSECT-N is a post-market registry designed to assess real-world safety and effectiveness of Valiant Navion Thoracic Stent Graft System in the treatment of thoracic aortic dissections in real world practice.

Description

DISSECT-N is a prospective, observational, global, multi-center, post-market registry designed to assess real-world safety and effectiveness of Valiant Navion Thoracic Stent Graft System in the treatment of thoracic aortic dissections in real world practice.

Details
Condition Thoracic Aortic Dissection
Age 18years - 100years
Treatment Valiant Navion Thoracic Stent Graft System
Clinical Study IdentifierNCT04267055
SponsorMedtronic Endovascular
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Subject is 18 years old
Subject was treated in the last 7 days, or is intended to be treated, with the Valiant Navion Thoracic Stent Graft System for a dissection in the thoracic aorta
Subject is willing to comply with standard of care clinical follow-up
Subject or legal representative has consented for study participation and signed the approved Informed Consent

Exclusion Criteria

Subject is participating in an investigational drug or device study which may bias or interfere with the endpoints and follow-up of this study
Subject is pregnant (not an exclusion if allowed per local regulatory requirements, pregnancy test to be performed where required)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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