Zenith® TXD Post-market Surveillance in Japan

June 6, 2023 updated by: Cook Group Incorporated

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

57

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukuoka, Japan, 812-8582
        • Kyushu University Hospital
      • Fukuoka, Japan, 802-8555
        • Kokura Memorial Hospital
      • Fukushima, Japan, 963-8563
        • Minami Tohoku Hospital
      • Fukushima, Japan, 973-8555
        • Iwaki Kyoritsu Hospital
      • Hokkaido, Japan, 041-8680
        • Hospital Hakodate Hokkaido
      • Hokkaido, Japan, 050-0076
        • Steel Memorial Muroran Hospital
      • Hyogo, Japan, 670-0981
        • Hyogo Brain and Heart Center
      • Mie, Japan, 514-8507
        • Mie University Hospital
      • Miyagi, Japan, 980-0873
        • Sendai Kousei Hospital
      • Nagoya, Japan, 390-8621
        • Shinshu University Hospital
      • Nara, Japan, 632-8552
        • Tenri Hospital
      • Oita, Japan, 879-5593
        • Oita University Hospital
      • Okinawa, Japan, 903-0215
        • University of the Ryukyus hospital
      • Osaka, Japan, 536-0025
        • Morinomiya Hospital
      • Osaka, Japan, 580-0032
        • Matsubara Tokushukai Hospital
      • Osaka, Japan, 589-8511
        • Kinki University Hospital, Faculty of Medicine
      • Saitama, Japan, 350-1298
        • Saitama International Medical Center
      • Tochigi, Japan, 321-0293
        • Dokkyo Medical Univercity Hospital
      • Tochigi, Japan, 321-0974
        • Saiseikai Utsunomiya Hospital
      • Tokyo, Japan, 162-8666
        • Tokyo Women's Medical University Hospital
      • Tokyo, Japan, 160-8582
        • Keio University Hospital
      • Tokyo, Japan, 105-8471
        • Jikei University School of Medicine
      • Tokyo, Japan, 160-0023
        • Tokyo Medical University Hospital
      • Tokyo, Japan, 180-8610
        • Japanese Red Cross Musashino Hospital
      • Yamagata, Japan, 990-2292
        • Yamagata Prefectural Central Hospital
      • Yamagata, Japan, 998-8501
        • Nihonkai General Hospital
      • Yamaguchi, Japan, 747-8511
        • Yamaguchi Grand Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients in Japan treated with TXD at investigational sites.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Aortic Dissection
Treating patients with acute complicated Stanford Type B aortic dissection with the Zenith® TXD
Device: Zenith® TXD
Zenith® TXD Dissection Stent Graft System for treatment of patients with aortic dissection of the descending thoracic aorta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook Group Incorporated

Investigators

  • Study Chair: Masaaki Kato, MD, Morinomiya Hospital
  • Study Chair: Kimihiko Kichikawa, MD, Nara Medical University Hospital
  • Study Chair: Hideyuki Shimizu, MD, Keio University Hospital
  • Study Chair: Joseph Lombardi, MD, The Cooper Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

March 28, 2023

Study Completion (Actual)

March 28, 2023

Study Registration Dates

First Submitted

January 22, 2016

First Submitted That Met QC Criteria

January 22, 2016

First Posted (Estimated)

January 26, 2016

Study Record Updates

Last Update Posted (Actual)

June 7, 2023

Last Update Submitted That Met QC Criteria

June 6, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-12

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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