Thoracic Aortic DissectionDISSECT-NNCT04267055
DISSECT-N Post Market Data Collection Registry
An observational study of Thoracic Aortic Dissection, run by Medtronic Cardiovascular at 22 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Aortic Dissection
- What is being tested?
- Valiant Navion Thoracic Stent Graft System
- Type of treatment
- Medical device
- How many people
- 102 participants
- Where
- 22 sitesin 10 countries
- Study dates
- 25 Jun 2020to 5 Jul 2024
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
22 sites in 10 countries.
22 sites in 10 countries
United States12 sites
Albany Medical Center
Albany, New York, 12208
University of Michigan Health System - University Hospital
Ann Arbor, Michigan, 48109
Emory University Hospital
Atlanta, Georgia, 30322
University of Alabama at Birmingham Hospital
Birmingham, Alabama, 35233
Medical University of South Carolina
Charleston, South Carolina, 29425
Atrium Health's Carolinas Medical Center
Charlotte, North Carolina, 28203
University of Florida Health Shands Hospital
Gainesville, Florida, 32608
UPMC Pinnacle Harrisburg Campus
Harrisburg, Pennsylvania, 17101
Northwell Health Lenox Hill Hospital
New York, New York, 10075
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Baylor Plano
Plano, Texas, 75903
Japan2 sites
National Cerebral and Cardiovascular Center
Suita, Osaka, 564-8565
Keio University Hospital
Tokyo, 108-8345
Slovakia1 site
Narodny Ustav Srdcovych a Cievnych Chorob, A.S.
Bratislava, 83348
About this study
Official title: 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.
Read the 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.
- Conditions
- Thoracic Aortic Dissection
- Being tested
- Valiant Navion Thoracic Stent Graft System
- Medical subject headings
- Dissection, Thoracic Aorta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valiant Navion Thoracic Stent Graft SystemDevice
Placement of the Valiant Navion for endovascular repair of a dissection in the thoracic aorta.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-month post index procedure
Secondary outcomes (12)
Aortic remodeling
Rate of aortic remodeling based on follow-up imaging.
Measured: 1-month, 1, 2 and 3 years
Access related complications
Rate of access related complications as proportion of evaluable patients.
Measured: peri-operative
Stent induced entry tear
Rate of stent induced entry tear as proportion of evaluable patients.
Measured: 1, 2 and 3 years
Stent graft migration
Rate of stent graft migration (>10mm) as proportion of evaluable patients.
Measured: 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.
Measured: 1-month, 1, 2 and 3 years
Disease progression
Extension of dissection.
Measured: 1,2 and 3 years
Transient Ischemic Attack (TIA)/minor strokes
Rate of TIA/minor stroke as a proportion of evaluable patients.
Measured: 1-month
Transient spinal cord ischemia
Rate of transient spinal cord ischemia as a proportion of evaluable patients.
Measured: 1-month, 1, 2 and 3 years
Unplanned secondary procedures
Rate of unplanned secondary procedures.
Measured: 1, 2 and 3 years
False lumen perfusion
Rate of each type of false lumen perfusion based on follow-up imaging.
Measured: 1-month, 1, 2 and 3 years
Endoleaks
Rate of each type of endoleak based on follow-up imaging.
Measured: 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
Measured: 1, 2 and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start25 Jun 2020
- Primary completion28 Jun 2021
- Study completion5 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Aortic DissectionStudies of the same condition, open and under way.
- More trials run by Medtronic CardiovascularThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Responsible party
- Sponsor
- Investigators
- Ross Milner, MD, Principal investigator, The University of Chicago Medicine & Biological Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04267055
- Sponsor's protocol ID
- MDT19030 DISSECT-N
- Acronym
- DISSECT-N
- Status last verified
- Jun 2025
- First submitted
- 29 Jan 2020
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DISSECT-N (Dissection Navion Registry)
- ClinicalTrials.gov ID
- NCT04267055
- Acronym / sponsor ID
- DISSECT-N / MDT19030 DISSECT-N
- Conditions
- Thoracic Aortic Dissection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Medtronic CardiovascularIndustry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Study start
- 25 Jun 2020 (actual)
- Primary completion
- 28 Jun 2021 (actual)
- Study completion
- 5 Jul 2024 (actual)
- First posted
- 12 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valiant Navion Thoracic Stent Graft SystemPlacement of the Valiant Navion for endovascular repair of a dissection in the thoracic aorta. | Device | – |
Primary outcome
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.
12 secondary outcomes
Aortic remodeling
Time frame: 1-month, 1, 2 and 3 years
Access related complications
Time frame: peri-operative
Stent induced entry tear
Time frame: 1, 2 and 3 years
Stent graft migration
Time frame: 1, 2 and 3 years
Stent graft integrity
Time frame: 1-month, 1, 2 and 3 years
Disease progression
Time frame: 1,2 and 3 years
Transient Ischemic Attack (TIA)/minor strokes
Time frame: 1-month
Transient spinal cord ischemia
Time frame: 1-month, 1, 2 and 3 years
Unplanned secondary procedures
Time frame: 1, 2 and 3 years
False lumen perfusion
Time frame: 1-month, 1, 2 and 3 years
Endoleaks
Time frame: 1-month, 1, 2 and 3 years
Major adverse events
Time frame: 1, 2 and 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ross Milner, MD principal investigator
The University of Chicago Medicine & Biological Sciences
22 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Aortic Dissection, run by Medtronic Cardiovascular at 22 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Japan, Denmark, Greece, Italy and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite safety and effectiveness (time frame: 1-month post index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.