Aortic DissectionNCT02663739
Zenith® TXD Post-market Surveillance in Japan
An observational study of Aortic Dissection, run by Cook Group Incorporated at 27 sites in Japan.
Trial summary
The study is a post-market surveillance study required by Japanese Regulatory Authorities as a condition of approval Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Dissection
- What is being tested?
- Zenith® TXD
- Type of treatment
- Medical device
- How many people
- 57 participants
- Where
- 27 sitesJapan
- Study dates
- Mar 2015to 28 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients in Japan treated with TXD at investigational sites.
Who may be able to join
- Patients with thoracic aortic dissection, including attempted cases
- Patients with acute Stanford type B aortic dissection, including attempted cases
Who cannot join
- Stanford type A aortic dissection and/or chronic type B aortic dissection
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
Japan27 sites
Kokura Memorial Hospital
Fukuoka, 802-8555
Kyushu University Hospital
Fukuoka, 812-8582
Minami Tohoku Hospital
Fukushima, 963-8563
Iwaki Kyoritsu Hospital
Fukushima, 973-8555
Hospital Hakodate Hokkaido
Hokkaido, 041-8680
Steel Memorial Muroran Hospital
Hokkaido, 050-0076
Hyogo Brain and Heart Center
Hyōgo, 670-0981
Mie University Hospital
Mie, 514-8507
Sendai Kousei Hospital
Miyagi, 980-0873
Shinshu University Hospital
Nagoya, 390-8621
Tenri Hospital
Nara, 632-8552
Oita University Hospital
Ōita, 879-5593
University of the Ryukyus Hospital
Okinawa, 903-0215
Morinomiya Hospital
Osaka, 536-0025
Matsubara Tokushukai Hospital
Osaka, 580-0032
Kinki University Hospital, Faculty of Medicine
Osaka, 589-8511
Saitama International Medical Center
Saitama, 350-1298
Dokkyo Medical Univercity Hospital
Tochigi, 321-0293
Saiseikai Utsunomiya Hospital
Tochigi, 321-0974
Jikei University School of Medicine
Tokyo, 105-8471
Tokyo Medical University Hospital
Tokyo, 160-0023
Keio University Hospital
Tokyo, 160-8582
Tokyo Women's Medical University Hospital
Tokyo, 162-8666
Japanese Red Cross Musashino Hospital
Tokyo, 180-8610
Yamagata Prefectural Central Hospital
Yamagata, 990-2292
Nihonkai General Hospital
Yamagata, 998-8501
Yamaguchi Grand Medical Center
Yamaguchi, 747-8511
About this study
Official title: 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
- Conditions
- Aortic Dissection
- Being tested
- Zenith® TXD
- Keywords
- Stanford type B aortic dissection, Malperfusion, Rupture, Acute disease, Endovascular procedures
- Medical subject headings
- Aortic Dissection, Rupture, Acute Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zenith® TXDDevice
Zenith® TXD Dissection Stent Graft System for treatment of patients with aortic dissection of the descending thoracic aorta
| Study group | Role | What they receive |
|---|---|---|
| Aortic Dissection | Treating patients with acute complicated Stanford Type B aortic dissection with the Zenith® TXD Receives: Device: Zenith® TXD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study startMar 2015
- Primary completion28 Mar 2023
- Study completion28 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic DissectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Masaaki Kato, MD, Study chair, Morinomiya HospitalKimihiko Kichikawa, MD, Study chair, Nara Medical University HospitalHideyuki Shimizu, MD, Study chair, Keio University HospitalJoseph Lombardi, MD, Study chair, The Cooper Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02663739
- Sponsor's protocol ID
- 13-12
- Status last verified
- Jun 2023
- First submitted
- 22 Jan 2016
- Last updated
- 7 Jun 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zenith TXD Dissection Stent Graft System Usage Results Surveillance in Japan for Treating Acute Complicated Stanford Type B Aortic Dissection
- ClinicalTrials.gov ID
- NCT02663739
- Acronym / sponsor ID
- 13-12
- Conditions
- Aortic Dissection
- Keywords
- Stanford type B aortic dissection, Malperfusion, Rupture, Acute disease, Endovascular procedures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- 28 Mar 2023 (actual)
- Study completion
- 28 Mar 2023 (actual)
- First posted
- 26 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a post-market surveillance study required by Japanese Regulatory Authorities as a condition of approval
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aortic Dissection | – | Device: Zenith® TXDTreating patients with acute complicated Stanford Type B aortic dissection with the Zenith® TXD |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients in Japan treated with TXD at investigational sites.
Key inclusion criteria (2 listed)
- Patients with thoracic aortic dissection, including attempted cases
- Patients with acute Stanford type B aortic dissection, including attempted cases
Key exclusion criteria (1 listed)
- Stanford type A aortic dissection and/or chronic type B aortic dissection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zenith® TXDZenith® TXD Dissection Stent Graft System for treatment of patients with aortic dissection of the descending thoracic aorta | Device | Aortic Dissection |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masaaki Kato, MD study chair
Morinomiya Hospital
Kimihiko Kichikawa, MD study chair
Nara Medical University Hospital
Hideyuki Shimizu, MD study chair
Keio University Hospital
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Dissection, run by Cook Group Incorporated at 27 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of major adverse events (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023; AzTrials last refreshed its copy on 26 Oct 2026.