DISSECT-N Post Market Data Collection Registry

Thoracic Aortic Dissection Clinical Trial

— DISSECT-N  

Official title:

DISSECT-N (Dissection Navion Registry)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04267055
• Other study ID #: MDT19030 - DISSECT-N
• Status: Active, not recruiting
• Start date: June 25, 2020
• Est. completion date: October 1, 2024

Study information

• Verified date: May 2024
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: October 1, 2024
• Est. primary completion date: June 28, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Dissection
• Thoracic Aortic Dissection

Intervention

Device:
• Valiant Navion Thoracic Stent Graft System
Placement of the Valiant Navion for endovascular repair of a dissection in the thoracic aorta.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	København
Greece	General Hospital of Athens, Evaggelismos	Athens
Italy	Ospedale San Raffaele - Milano	Milan
Japan	National Cerebral and Cardiovascular Center	Suita	Osaka
Japan	Keio University Hospital	Tokyo
Korea, Republic of	Severance Hospital	Seoul
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
New Zealand	Auckland City Hospital	Grafton
Slovakia	Narodny Ustav Srdcovych a Cievnych Chorob, A.S.	Bratislava
Thailand	Songklanagarind Hospital	Hat Yai	Songkhla
United States	Albany Medical Center	Albany	New York
United States	University of Michigan Health System - University Hospital	Ann Arbor	Michigan
United States	Emory University Hospital	Atlanta	Georgia
United States	University of Alabama at Birmingham Hospital	Birmingham	Alabama
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Atrium Health's Carolinas Medical Center	Charlotte	North Carolina
United States	University of Florida Health Shands Hospital	Gainesville	Florida
United States	UPMC Pinnacle Harrisburg Campus	Harrisburg	Pennsylvania
United States	Northwell Health Lenox Hill Hospital	New York	New York
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Baylor Plano	Plano	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Cardiovascular	NAMSA

Countries where clinical trial is conducted

United States,  Denmark,  Greece,  Italy,  Japan,  Korea, Republic of,  Netherlands,  New Zealand,  Slovakia,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1-month post index procedure
Secondary	Aortic remodeling	Rate of aortic remodeling based on follow-up imaging.	1-month, 1, 2 and 3 years
Secondary	Access related complications	Rate of access related complications as proportion of evaluable patients.	peri-operative
Secondary	Stent induced entry tear	Rate of stent induced entry tear as proportion of evaluable patients.	1, 2 and 3 years
Secondary	Stent graft migration	Rate of stent graft migration (>10mm) as proportion of evaluable patients.	1, 2 and 3 years
Secondary	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.	1-month, 1, 2 and 3 years
Secondary	Disease progression	Extension of dissection.	1,2 and 3 years
Secondary	Transient Ischemic Attack (TIA)/minor strokes	Rate of TIA/minor stroke as a proportion of evaluable patients.	1-month
Secondary	Transient spinal cord ischemia	Rate of transient spinal cord ischemia as a proportion of evaluable patients.	1-month, 1, 2 and 3 years
Secondary	Unplanned secondary procedures	Rate of unplanned secondary procedures.	1, 2 and 3 years
Secondary	False lumen perfusion	Rate of each type of false lumen perfusion based on follow-up imaging.	1-month, 1, 2 and 3 years
Secondary	Endoleaks	Rate of each type of endoleak based on follow-up imaging.	1-month, 1, 2 and 3 years
Secondary	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	1, 2 and 3 years