DISSECT-N Post Market Data Collection Registry

NCT04267055 | Completed FDA Device

• 1 other identifier: MDT19030 DISSECT-N
• Study Type: observational
• Target: 102
• Locations: 10 countries
• Sites: 22

Brief 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.

Conditions

Thoracic Aortic Dissection

Outcome Measures

Primary Outcomes (1)

• Composite safety and effectiveness

  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.

  1-month post index procedure

Secondary Outcomes (12)

• Aortic remodeling

  1-month, 1, 2 and 3 years

• Access related complications

  peri-operative

• Stent induced entry tear

  1, 2 and 3 years

• Stent graft migration

  1, 2 and 3 years

• Stent graft integrity

  1-month, 1, 2 and 3 years

Interventions

Valiant Navion Thoracic Stent Graft System DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population shall include all subjects diagnosed with a dissection of the thoracic aorta who have been treated, or are intended to be treated, with the Valiant Navion.

You may qualify if:

• 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

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Medtronic Cardiovascular: lead
• NAMSA: collaborator

Study Sites (22)

University of Alabama at Birmingham Hospital

Birmingham, Alabama, 35233, United States

Location

University of Florida Health Shands Hospital

Gainesville, Florida, 32608, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

University of Michigan Health System - University Hospital

Ann Arbor, Michigan, 48109, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

Northwell Health Lenox Hill Hospital

New York, New York, 10075, United States

Location

Atrium Health's Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

UPMC Pinnacle Harrisburg Campus

Harrisburg, Pennsylvania, 17101, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Baylor Plano

Plano, Texas, 75903, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

General Hospital of Athens, Evaggelismos

Athens, 10676, Greece

Location

Ospedale San Raffaele - Milano

Milan, 20132, Italy

Location

National Cerebral and Cardiovascular Center

Suita, Osaka, 564-8565, Japan

Location

Keio University Hospital

Tokyo, 108-8345, Japan

Location

St. Antonius Ziekenhuis

Nieuwegein, 3435 CM, Netherlands

Location

Auckland City Hospital

Grafton, 1023, New Zealand

Location

Narodny Ustav Srdcovych a Cievnych Chorob, A.S.

Bratislava, 83348, Slovakia

Location

Severance Hospital

Seoul, 03722, South Korea

Location

Songklanagarind Hospital

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Dissection, Thoracic Aorta

Condition Hierarchy (Ancestors)

Aortic Dissection; Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases

Study Officials

• Ross Milner, MD

  The University of Chicago Medicine & Biological Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: February 12, 2020
• Study Start: June 25, 2020
• Primary Completion: June 28, 2021
• Study Completion: July 5, 2024
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1); GR (1); SL (1); TH (1); IT (1); US (12); JP (2); NL (1); DK (1); KR (1)