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OpenTrials
Completed

NCT Number: NCT02663739

Zenith® TXD Post-market Surveillance in Japan

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

Completed

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Key information

Conditions

Aortic Dissection Acute Aortic Syndrome Acute Disease Aneurysm Aortic Diseases Cardiovascular Diseases Disease Attributes Dissection, Blood Vessel Pathologic Processes Pathological Conditions, Signs and Symptoms Rupture Vascular Diseases Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

Kokura Memorial Hospital, Fukuoka, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zenith® TXD

Device

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

Primary outcomes

  1. Rate of major adverse events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
Jan 26, 2016
Registry last updated
Jun 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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