This trial is active, not recruiting.

Condition aortic dissection
Treatment zenith® txd
Sponsor Cook
Start date March 2015
End date November 2017
Trial size 39 participants
Trial identifier NCT02663739, 13-12


The study is a post-market surveillance study required by Japanese Regulatory Authorities as a condition of approval

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Treating patients with acute complicated Stanford Type B aortic dissection with the Zenith® TXD
zenith® txd
Zenith® TXD Dissection Stent Graft System for treatment of patients with aortic dissection of the descending thoracic aorta

Primary Outcomes

Rate of major adverse events
time frame: 5 years

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Patients with thoracic aortic dissection, including attempted cases - Patients with acute Stanford type B aortic dissection, including attempted cases Exclusion Criteria: - Stanford type A aortic dissection and/or chronic type B aortic dissection

Additional Information

Official title Zenith TXD Dissection Stent Graft System Usage Results Surveillance in Japan for Treating Acute Complicated Stanford Type B Aortic Dissection
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Cook.