Zenith® TXD Post-market Surveillance in Japan

Zenith TXD Dissection Stent Graft System Usage Results Surveillance in Japan for Treating Acute Complicated Stanford Type B Aortic Dissection

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02663739

Enrollment

Registered

2016-01-26

Start date

2015-03-31

Completion date

2023-03-28

Last updated

2023-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Dissection

Keywords

Stanford type B aortic dissection, Malperfusion, Rupture, Acute disease, Endovascular procedures

Brief summary

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

Interventions

DEVICEZenith® TXD

Zenith® TXD Dissection Stent Graft System for treatment of patients with aortic dissection of the descending thoracic aorta

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Rate of major adverse events	5 years	Major adverse events will include death, aortic rupture, conversion to open surgical repair, spinal cord ischemia, retrograde progression of dissection, myocardial infarction, renal failure requiring dialysis, intestinal ischemia, stroke, paraplegia, and \> 72 hours artificial respiratory assistance.

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026