An observational study in Thoracic Aortic Dissection, sponsored by Medtronic Cardiovascular. Completed at 22 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-03.
Sponsored by Medtronic Cardiovascular (part of Medtronic) · Observational
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.
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.
30 studies on the registry are indexed under Dissection, Thoracic Aorta; 10 are open to participants now.
This study's enrollment of 102 is close to the median of 102 across 17 observational studies indexed under Dissection, Thoracic Aorta.
Browse Dissection, Thoracic Aorta studies →Medtronic Cardiovascular is the lead sponsor of 70 studies on the registry; 7 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Placement of the Valiant Navion for endovascular repair of a dissection in the thoracic aorta.
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.
Time frame: 1-month post index procedure
Aortic remodeling
Rate of aortic remodeling based on follow-up imaging.
Time frame: 1-month, 1, 2 and 3 years
Access related complications
Rate of access related complications as proportion of evaluable patients.
Time frame: peri-operative
Stent induced entry tear
Rate of stent induced entry tear as proportion of evaluable patients.
Time frame: 1, 2 and 3 years
Stent graft migration
Rate of stent graft migration (\>10mm) as proportion of evaluable patients.
Time frame: 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.
Time frame: 1-month, 1, 2 and 3 years
Disease progression
Extension of dissection.
Time frame: 1,2 and 3 years
Transient Ischemic Attack (TIA)/minor strokes
Rate of TIA/minor stroke as a proportion of evaluable patients.
Time frame: 1-month
Transient spinal cord ischemia
Rate of transient spinal cord ischemia as a proportion of evaluable patients.
Time frame: 1-month, 1, 2 and 3 years
Unplanned secondary procedures
Rate of unplanned secondary procedures.
Time frame: 1, 2 and 3 years
False lumen perfusion
Rate of each type of false lumen perfusion based on follow-up imaging.
Time frame: 1-month, 1, 2 and 3 years
Endoleaks
Rate of each type of endoleak based on follow-up imaging.
Time frame: 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
Time frame: 1, 2 and 3 years
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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