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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04267055
Registration number
NCT04267055
Ethics application status
Date submitted
29/01/2020
Date registered
12/02/2020
Titles & IDs
Public title
DISSECT-N Post Market Data Collection Registry
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Scientific title
DISSECT-N (Dissection Navion Registry)
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Secondary ID [1]
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MDT19030 - DISSECT-N
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Universal Trial Number (UTN)
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Trial acronym
DISSECT-N
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Thoracic Aortic Dissection
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Condition category
Condition code
Cardiovascular
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Other cardiovascular diseases
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Devices - Valiant Navion Thoracic Stent Graft System
Treatment: Devices: Valiant Navion Thoracic Stent Graft System
Placement of the Valiant Navion for endovascular repair of a dissection in the thoracic aorta.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Composite safety and effectiveness
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Assessment method [1]
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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.
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Timepoint [1]
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1-month post index procedure
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Secondary outcome [1]
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Aortic remodeling
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Assessment method [1]
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Rate of aortic remodeling based on follow-up imaging.
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Timepoint [1]
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1-month, 1, 2 and 3 years
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Secondary outcome [2]
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Access related complications
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Assessment method [2]
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Rate of access related complications as proportion of evaluable patients.
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Timepoint [2]
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peri-operative
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Secondary outcome [3]
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Stent induced entry tear
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Assessment method [3]
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Rate of stent induced entry tear as proportion of evaluable patients.
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Timepoint [3]
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1, 2 and 3 years
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Secondary outcome [4]
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Stent graft migration
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Assessment method [4]
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Rate of stent graft migration (\>10mm) as proportion of evaluable patients.
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Timepoint [4]
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1, 2 and 3 years
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Secondary outcome [5]
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Stent graft integrity
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Assessment method [5]
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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.
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Timepoint [5]
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1-month, 1, 2 and 3 years
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Secondary outcome [6]
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Disease progression
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Assessment method [6]
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Extension of dissection.
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Timepoint [6]
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1,2 and 3 years
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Secondary outcome [7]
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Transient Ischemic Attack (TIA)/minor strokes
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Assessment method [7]
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Rate of TIA/minor stroke as a proportion of evaluable patients.
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Timepoint [7]
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1-month
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Secondary outcome [8]
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Transient spinal cord ischemia
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Assessment method [8]
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Rate of transient spinal cord ischemia as a proportion of evaluable patients.
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Timepoint [8]
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1-month, 1, 2 and 3 years
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Secondary outcome [9]
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Unplanned secondary procedures
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Assessment method [9]
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Rate of unplanned secondary procedures.
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Timepoint [9]
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1, 2 and 3 years
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Secondary outcome [10]
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False lumen perfusion
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Assessment method [10]
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Rate of each type of false lumen perfusion based on follow-up imaging.
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Timepoint [10]
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1-month, 1, 2 and 3 years
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Secondary outcome [11]
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Endoleaks
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Assessment method [11]
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Rate of each type of endoleak based on follow-up imaging.
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Timepoint [11]
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1-month, 1, 2 and 3 years
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Secondary outcome [12]
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Major adverse events
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Assessment method [12]
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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
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Timepoint [12]
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1, 2 and 3 years
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
25/06/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/10/2024
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Country [2]
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United States of America
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State/province [2]
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Florida
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Country [3]
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United States of America
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State/province [3]
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Georgia
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Country [4]
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United States of America
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State/province [4]
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Michigan
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Country [5]
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United States of America
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State/province [5]
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New York
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Country [6]
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United States of America
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State/province [6]
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North Carolina
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Country [7]
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United States of America
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State/province [7]
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Pennsylvania
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Country [8]
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United States of America
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State/province [8]
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South Carolina
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Country [9]
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United States of America
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State/province [9]
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Texas
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Country [10]
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United States of America
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State/province [10]
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Virginia
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Country [11]
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Denmark
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State/province [11]
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København
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Country [12]
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Greece
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State/province [12]
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Athens
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Country [13]
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Italy
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State/province [13]
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Milan
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Country [14]
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Japan
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State/province [14]
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Osaka
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Country [15]
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Japan
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State/province [15]
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Tokyo
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Country [16]
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Korea, Republic of
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State/province [16]
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Seoul
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Country [17]
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Netherlands
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State/province [17]
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Nieuwegein
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Country [18]
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New Zealand
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State/province [18]
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Grafton
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Country [19]
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Slovakia
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State/province [19]
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Bratislava
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Country [20]
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Thailand
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State/province [20]
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Songkhla
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Medtronic Cardiovascular
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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NAMSA
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT04267055
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Ross Milner, MD
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Address
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The University of Chicago Medicine & Biological Sciences
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04267055