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Completed

NCT Number: NCT04267055

DISSECT-N Post Market Data Collection Registry

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.

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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

Rigshospitalet, Copenhagen, Denmark

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About this study

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.

Who can participate

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

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 or consultee, as applicable 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)
  • Subject has an active COVID-19 infection or relevant history of COVID-19. Relevant history of COVID-19 is defined as availability of a positive COVID-19 test with sequela or hospitalization for treatment of COVID-19. Subjects with a positive COVID-19 test who were asymptomatic or had mild symptoms should be excluded only if the positive test was less than 3 months prior to enrollment.

Treatment and study plan

Valiant Navion Thoracic Stent Graft System

Device

Placement of the Valiant Navion for endovascular repair of a dissection in the thoracic aorta.

Primary outcomes

  1. Composite safety and effectiveness

    Time frame: 1-month post index procedure

    Safety: Major Adverse Events (MAEs) Defined as: all-cause mortality (ACM), retrograde type A dissection (RTAD), aortic rupture, permanent paraplegia and paraparesis, stent induced new entry tear, conversion to open repair, disabling stroke, and non-preexisting renal failure.

    Effectiveness: Technical success defined as ability to advance, deploy and position the Valiant Navion Thoracic Stent Graft at target site with successful coverage and sealing of the proximal entry tear and removal of the delivery system.

    The primary endpoint is a dichotomous study outcome and a composite endpoint. A subject who has technical success and no MAE reported within 1-month will be considered a success.

Secondary outcomes

  1. Aortic remodeling

    Time frame: 1-month, 1, 2 and 3 years

    Rate of aortic remodeling based on follow-up imaging.

  2. Access related complications

    Time frame: peri-operative

    Rate of access related complications as proportion of evaluable patients.

  3. Stent induced entry tear

    Time frame: 1, 2 and 3 years

    Rate of stent induced entry tear as proportion of evaluable patients.

  4. Stent graft migration

    Time frame: 1, 2 and 3 years

    Rate of stent graft migration (>10mm) as proportion of evaluable patients.

  5. Stent graft integrity

    Time frame: 1-month, 1, 2 and 3 years

    Rate of each type of loss of stent graft integrity (kink, twist, fracture, occlusion, or stenosis) as a proportion of evaluable patients based on follow-up imaging.

  6. Disease progression

    Time frame: 1,2 and 3 years

    Extension of dissection.

  7. Transient Ischemic Attack (TIA)/minor strokes

    Time frame: 1-month

    Rate of TIA/minor stroke as a proportion of evaluable patients.

  8. Transient spinal cord ischemia

    Time frame: 1-month, 1, 2 and 3 years

    Rate of transient spinal cord ischemia as a proportion of evaluable patients.

  9. Unplanned secondary procedures

    Time frame: 1, 2 and 3 years

    Rate of unplanned secondary procedures.

  10. False lumen perfusion

    Time frame: 1-month, 1, 2 and 3 years

    Rate of each type of false lumen perfusion based on follow-up imaging.

  11. Endoleaks

    Time frame: 1-month, 1, 2 and 3 years

    Rate of each type of endoleak based on follow-up imaging.

  12. Major adverse events

    Time frame: 1, 2 and 3 years

    Major 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

Sponsors and collaborators

Lead sponsor

Medtronic Cardiovascular

Industry

Collaborators

  • NAMSA

Registry information

Official study title

DISSECT-N (Dissection Navion Registry)

Acronym: DISSECT-N

Important dates

Study start
2020
Primary completion
2021
Study completion
2024
First posted
Feb 12, 2020
Registry last updated
Jul 3, 2025

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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