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)
Kokura Memorial Hospital
🇯🇵Fukuoka, Japan
Kyushu University Hospital
🇯🇵Fukuoka, Japan
Minami Tohoku Hospital
🇯🇵Fukushima, Japan
Iwaki Kyoritsu Hospital
🇯🇵Fukushima, Japan
Hospital Hakodate Hokkaido
🇯🇵Hokkaido, Japan
Steel Memorial Muroran Hospital
🇯🇵Hokkaido, Japan
Hyogo Brain and Heart Center
🇯🇵Hyogo, Japan
Mie University Hospital
🇯🇵Mie, Japan
Sendai Kousei Hospital
🇯🇵Miyagi, Japan
Shinshu University Hospital
🇯🇵Nagoya, Japan
Scroll for more (17 remaining)Kokura Memorial Hospital🇯🇵Fukuoka, Japan