Zenith® TXD Post-market Surveillance in Japan

NCT ID: NCT02663739

Last Updated: 2023-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2023-03-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aortic Dissection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Aortic Dissection

Treating patients with acute complicated Stanford Type B aortic dissection with the Zenith® TXD

Zenith® TXD

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Zenith® TXD

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cook Group Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Masaaki Kato, MD

Role: STUDY_CHAIR

Morinomiya Hospital

Kimihiko Kichikawa, MD

Role: STUDY_CHAIR

Nara Medical University Hospital

Hideyuki Shimizu, MD

Role: STUDY_CHAIR

Keio University Hospital

Joseph Lombardi, MD

Role: STUDY_CHAIR

The Cooper Health System

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kokura Memorial Hospital

Fukuoka, , Japan

Site Status

Kyushu University Hospital

Fukuoka, , Japan

Site Status

Minami Tohoku Hospital

Fukushima, , Japan

Site Status

Iwaki Kyoritsu Hospital

Fukushima, , Japan

Site Status

Hospital Hakodate Hokkaido

Hokkaido, , Japan

Site Status

Steel Memorial Muroran Hospital

Hokkaido, , Japan

Site Status

Hyogo Brain and Heart Center

Hyōgo, , Japan

Site Status

Mie University Hospital

Mie, , Japan

Site Status

Sendai Kousei Hospital

Miyagi, , Japan

Site Status

Shinshu University Hospital

Nagoya, , Japan

Site Status

Tenri Hospital

Nara, , Japan

Site Status

University of the Ryukyus Hospital

Okinawa, , Japan

Site Status

Morinomiya Hospital

Osaka, , Japan

Site Status

Matsubara Tokushukai Hospital

Osaka, , Japan

Site Status

Kinki University Hospital, Faculty of Medicine

Osaka, , Japan

Site Status

Oita University Hospital

Ōita, , Japan

Site Status

Saitama International Medical Center

Saitama, , Japan

Site Status

Dokkyo Medical Univercity Hospital

Tochigi, , Japan

Site Status

Saiseikai Utsunomiya Hospital

Tochigi, , Japan

Site Status

Jikei University School of Medicine

Tokyo, , Japan

Site Status

Tokyo Medical University Hospital

Tokyo, , Japan

Site Status

Keio University Hospital

Tokyo, , Japan

Site Status

Tokyo Women's Medical University Hospital

Tokyo, , Japan

Site Status

Japanese Red Cross Musashino Hospital

Tokyo, , Japan

Site Status

Yamagata Prefectural Central Hospital

Yamagata, , Japan

Site Status

Nihonkai General Hospital

Yamagata, , Japan

Site Status

Yamaguchi Grand Medical Center

Yamaguchi, , Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

13-12

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Zenith® Fenestrated+ Clinical Study
NCT04875429 ACTIVE_NOT_RECRUITING NA