Zenith® TXD Post-market Surveillance in Japan
- Conditions
- Aortic Dissection
- Interventions
- Device: Zenith® TXD
- Registration Number
- NCT02663739
- Lead Sponsor
- Cook Group Incorporated
- Brief Summary
The study is a post-market surveillance study required by Japanese Regulatory Authorities as a condition of approval
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57
- Patients with thoracic aortic dissection, including attempted cases
- Patients with acute Stanford type B aortic dissection, including attempted cases
- Stanford type A aortic dissection and/or chronic type B aortic dissection
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Aortic Dissection Zenith® TXD Treating patients with acute complicated Stanford Type B aortic dissection with the Zenith® TXD
- Primary Outcome Measures
Name Time Method Rate of major adverse events 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (27)
Kyushu University Hospital
🇯🇵Fukuoka, Japan
Minami Tohoku Hospital
🇯🇵Fukushima, Japan
Hyogo Brain and Heart Center
🇯🇵Hyogo, Japan
Hospital Hakodate Hokkaido
🇯🇵Hokkaido, Japan
Tenri Hospital
🇯🇵Nara, Japan
Kinki University Hospital, Faculty of Medicine
🇯🇵Osaka, Japan
Saiseikai Utsunomiya Hospital
🇯🇵Tochigi, Japan
Japanese Red Cross Musashino Hospital
🇯🇵Tokyo, Japan
Kokura Memorial Hospital
🇯🇵Fukuoka, Japan
Iwaki Kyoritsu Hospital
🇯🇵Fukushima, Japan
Steel Memorial Muroran Hospital
🇯🇵Hokkaido, Japan
Mie University Hospital
🇯🇵Mie, Japan
Sendai Kousei Hospital
🇯🇵Miyagi, Japan
Shinshu University Hospital
🇯🇵Nagoya, Japan
Morinomiya Hospital
🇯🇵Osaka, Japan
Oita University Hospital
🇯🇵Oita, Japan
Matsubara Tokushukai Hospital
🇯🇵Osaka, Japan
University of the Ryukyus Hospital
🇯🇵Okinawa, Japan
Saitama International Medical Center
🇯🇵Saitama, Japan
Dokkyo Medical Univercity Hospital
🇯🇵Tochigi, Japan
Jikei University School of Medicine
🇯🇵Tokyo, Japan
Keio University Hospital
🇯🇵Tokyo, Japan
Tokyo Women's Medical University Hospital
🇯🇵Tokyo, Japan
Tokyo Medical University Hospital
🇯🇵Tokyo, Japan
Yamagata Prefectural Central Hospital
🇯🇵Yamagata, Japan
Nihonkai General Hospital
🇯🇵Yamagata, Japan
Yamaguchi Grand Medical Center
🇯🇵Yamaguchi, Japan