DISSECT-N Post Market Data Collection Registry (DISSECT-N)

DISSECT-N (Dissection Navion 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Thoracic Aortic Dissection
• Intervention / Treatment: Device: Valiant Navion Thoracic Stent Graft System

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Denmark
  • København, Denmark, 2100
    • Rigshospitalet
• Greece
  • Athens, Greece, 10676
    • General Hospital of Athens, Evaggelismos
• Italy
  • Milan, Italy, 20132
    • Ospedale San Raffaele - Milano
• Japan
  • Tokyo, Japan, 108-8345
    • Keio University Hospital
  • Osaka
    • Suita, Osaka, Japan, 564-8565
      • National Cerebral and Cardiovascular Center
• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital
• Netherlands
  • Nieuwegein, Netherlands, 3435 CM
    • St. Antonius Ziekenhuis
• New Zealand
  • Grafton, New Zealand, 1023
    • Auckland City Hospital
• Slovakia
  • Bratislava, Slovakia, 83348
    • Narodny ustav srdcovych a cievnych chorob, a.s.
• Thailand
  • Songkhla
    • Hat Yai, Songkhla, Thailand, 90110
      • Songklanagarind Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham Hospital
  • Florida
    • Gainesville, Florida, United States, 32608
      • University of Florida Health Shands Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health System - University Hospital
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical Center
    • New York, New York, United States, 10075
      • Northwell Health Lenox Hill Hospital
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Atrium Health's Carolinas Medical Center
  • Pennsylvania
    • Harrisburg, Pennsylvania, United States, 17101
      • UPMC Pinnacle Harrisburg Campus
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • Plano, Texas, United States, 75903
      • Baylor Plano
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aortic remodeling	Rate of aortic remodeling based on follow-up imaging.	1-month, 1, 2 and 3 years
Access related complications	Rate of access related complications as proportion of evaluable patients.	peri-operative
Stent induced entry tear	Rate of stent induced entry tear as proportion of evaluable patients.	1, 2 and 3 years
Stent graft migration	Rate of stent graft migration (>10mm) as proportion of evaluable patients.	1, 2 and 3 years
Stent graft integrity	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.	1-month, 1, 2 and 3 years
Disease progression	Extension of dissection.	1,2 and 3 years
Transient Ischemic Attack (TIA)/minor strokes	Rate of TIA/minor stroke as a proportion of evaluable patients.	1-month
Transient spinal cord ischemia	Rate of transient spinal cord ischemia as a proportion of evaluable patients.	1-month, 1, 2 and 3 years
Unplanned secondary procedures	Rate of unplanned secondary procedures.	1, 2 and 3 years
False lumen perfusion	Rate of each type of false lumen perfusion based on follow-up imaging.	1-month, 1, 2 and 3 years
Endoleaks	Rate of each type of endoleak based on follow-up imaging.	1-month, 1, 2 and 3 years
Major adverse events	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	1, 2 and 3 years

Collaborators and Investigators

• Sponsor: Medtronic Cardiovascular
• Collaborators: NAMSA
• Investigators: Principal Investigator: Ross Milner, MD, The University of Chicago Medicine & Biological Sciences

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2020
• Primary Completion (Actual): June 28, 2021
• Study Completion (Anticipated): October 1, 2024

Study Registration Dates

• First Submitted: January 29, 2020
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (Actual): February 12, 2020

Study Record Updates

• Last Update Posted (Actual): May 15, 2023
• Last Update Submitted That Met QC Criteria: May 12, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aneurysm, Dissecting
• Other Study ID Numbers: MDT19030 - DISSECT-N

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes