Zenith® TXD Post-market Surveillance in Japan

N/ACompletedNCT02663739

Cook Group Incorporated57 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Aortic Dissection

Interventions

Zenith® TXDDEVICE

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (27)

Kokura Memorial Hospital

Fukuoka, Japan

Outcomes

Primary Outcomes

Rate of major adverse events

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.

Time frame: 5 years

Data from ClinicalTrials.gov

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