DISSECT-N Post Market Data Collection Registry

NCT ID: NCT04267055

Last Updated: 2025-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-25

Study Completion Date

2024-07-05

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Thoracic Aortic Dissection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Valiant Navion Thoracic Stent Graft System

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NAMSA

OTHER

Sponsor Role collaborator

Medtronic Cardiovascular

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ross Milner, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Chicago Medicine & Biological Sciences

Locations

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University of Alabama at Birmingham Hospital

Birmingham, Alabama, United States

Site Status

University of Florida Health Shands Hospital

Gainesville, Florida, United States

Site Status

Emory University Hospital

Atlanta, Georgia, United States

Site Status

University of Michigan Health System - University Hospital

Ann Arbor, Michigan, United States

Site Status

Albany Medical Center

Albany, New York, United States

Site Status

Northwell Health Lenox Hill Hospital

New York, New York, United States

Site Status

Atrium Health's Carolinas Medical Center

Charlotte, North Carolina, United States

Site Status

UPMC Pinnacle Harrisburg Campus

Harrisburg, Pennsylvania, United States

Site Status

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Baylor Plano

Plano, Texas, United States

Site Status

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Site Status

Rigshospitalet

Copenhagen, , Denmark

Site Status

General Hospital of Athens, Evaggelismos

Athens, , Greece

Site Status

Ospedale San Raffaele - Milano

Milan, , Italy

Site Status

National Cerebral and Cardiovascular Center

Suita, Osaka, Japan

Site Status

Keio University Hospital

Tokyo, , Japan

Site Status

St. Antonius Ziekenhuis

Nieuwegein, , Netherlands

Site Status

Auckland City Hospital

Grafton, , New Zealand

Site Status

Narodny Ustav Srdcovych a Cievnych Chorob, A.S.

Bratislava, , Slovakia

Site Status

Severance Hospital

Seoul, , South Korea

Site Status

Songklanagarind Hospital

Hat Yai, Changwat Songkhla, Thailand

Site Status

Countries

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United States Denmark Greece Italy Japan Netherlands New Zealand Slovakia South Korea Thailand

Other Identifiers

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MDT19030 DISSECT-N

Identifier Type: -

Identifier Source: org_study_id

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