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

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

Study Overview

• Status: Completed
• Conditions: Aortic Dissection
• Intervention / Treatment: Device: Zenith® TXD

• Study Type: Observational
• Enrollment (Actual): 57

Contacts and Locations

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

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

How is the study designed?

Design Details

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

Number of groups / cohorts

1

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	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

• 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

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: Malperfusion; Stanford type B aortic dissection; Rupture; Acute disease; Endovascular procedures
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aortic Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome; Aortic Dissection
• 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