Clinical trial NCT04267055: DISSECT-N Post Market Data Collection Registry
Official title: DISSECT-N (Dissection Navion Registry)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Aortic Dissection
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
Collaborators: name: NAMSA
First posted: 2020-02-12
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Composite safety and effectiveness
timeFrame: 1-month post index procedure
Secondary outcomes:
measure: Aortic remodeling
timeFrame: 1-month, 1, 2 and 3 years
measure: Access related complications
timeFrame: peri-operative
measure: Stent induced entry tear
timeFrame: 1, 2 and 3 years
measure: Stent graft migration
timeFrame: 1, 2 and 3 years
measure: Stent graft integrity
timeFrame: 1-month, 1, 2 and 3 years
measure: Disease progression
timeFrame: 1,2 and 3 years
measure: Transient Ischemic Attack (TIA)/minor strokes
timeFrame: 1-month
measure: Transient spinal cord ischemia
timeFrame: 1-month, 1, 2 and 3 years
measure: Unplanned secondary procedures
timeFrame: 1, 2 and 3 years
measure: False lumen perfusion
timeFrame: 1-month, 1, 2 and 3 years
measure: Endoleaks
timeFrame: 1-month, 1, 2 and 3 years
measure: Major adverse events
timeFrame: 1, 2 and 3 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Hospital
state: Alabama
city: Gainesville
country: United States
facility: University of Florida Health Shands Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Ann Arbor
country: United States
facility: University of Michigan Health System - University Hospital
state: Michigan
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: New York
country: United States
facility: Northwell Health Lenox Hill Hospital
state: New York
city: Charlotte
country: United States
facility: Atrium Health's Carolinas Medical Center
state: North Carolina
city: Harrisburg
country: United States
facility: UPMC Pinnacle Harrisburg Campus
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Plano
country: United States
facility: Baylor Plano
state: Texas
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: København
country: Denmark
facility: Rigshospitalet
city: Athens
country: Greece
facility: General Hospital of Athens, Evaggelismos
city: Milan
country: Italy
facility: Ospedale San Raffaele - Milano
city: Suita
country: Japan
facility: National Cerebral and Cardiovascular Center
state: Osaka
city: Tokyo
country: Japan
facility: Keio University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Grafton
country: New Zealand
facility: Auckland City Hospital
city: Bratislava
country: Slovakia
facility: Narodny Ustav Srdcovych a Cievnych Chorob, A.S.
city: Hat Yai
country: Thailand
facility: Songklanagarind Hospital
state: Songkhla
Study officials:
affiliation: The University of Chicago Medicine & Biological Sciences
name: Ross Milner, MD
role: PRINCIPAL_INVESTIGATOR
References: