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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
Scientific title
DISSECT-N (Dissection Navion Registry)
Secondary ID [1] 0 0
MDT19030 DISSECT-N
Universal Trial Number (UTN)
Trial acronym
DISSECT-N
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thoracic Aortic Dissection 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite safety and effectiveness
Timepoint [1] 0 0
1-month post index procedure
Secondary outcome [1] 0 0
Aortic remodeling
Timepoint [1] 0 0
1-month, 1, 2 and 3 years
Secondary outcome [2] 0 0
Access related complications
Timepoint [2] 0 0
peri-operative
Secondary outcome [3] 0 0
Stent induced entry tear
Timepoint [3] 0 0
1, 2 and 3 years
Secondary outcome [4] 0 0
Stent graft migration
Timepoint [4] 0 0
1, 2 and 3 years
Secondary outcome [5] 0 0
Stent graft integrity
Timepoint [5] 0 0
1-month, 1, 2 and 3 years
Secondary outcome [6] 0 0
Disease progression
Timepoint [6] 0 0
1,2 and 3 years
Secondary outcome [7] 0 0
Transient Ischemic Attack (TIA)/minor strokes
Timepoint [7] 0 0
1-month
Secondary outcome [8] 0 0
Transient spinal cord ischemia
Timepoint [8] 0 0
1-month, 1, 2 and 3 years
Secondary outcome [9] 0 0
Unplanned secondary procedures
Timepoint [9] 0 0
1, 2 and 3 years
Secondary outcome [10] 0 0
False lumen perfusion
Timepoint [10] 0 0
1-month, 1, 2 and 3 years
Secondary outcome [11] 0 0
Endoleaks
Timepoint [11] 0 0
1-month, 1, 2 and 3 years
Secondary outcome [12] 0 0
Major adverse events
Timepoint [12] 0 0
1, 2 and 3 years

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/06/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/07/2024
Sample size
Target
Accrual to date
Final
102
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
South Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Virginia
Country [11] 0 0
Denmark
State/province [11] 0 0
København
Country [12] 0 0
Greece
State/province [12] 0 0
Athens
Country [13] 0 0
Italy
State/province [13] 0 0
Milan
Country [14] 0 0
Japan
State/province [14] 0 0
Osaka
Country [15] 0 0
Japan
State/province [15] 0 0
Tokyo
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Seoul
Country [17] 0 0
Netherlands
State/province [17] 0 0
Nieuwegein
Country [18] 0 0
New Zealand
State/province [18] 0 0
Grafton
Country [19] 0 0
Slovakia
State/province [19] 0 0
Bratislava
Country [20] 0 0
Thailand
State/province [20] 0 0
Songkhla

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Medtronic Cardiovascular
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
NAMSA
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ross Milner, MD
Address 0 0
The University of Chicago Medicine & Biological Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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