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The study is a post-market surveillance study required by Japanese Regulatory Authorities as a condition of approval
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aortic Dissection | Treating patients with acute complicated Stanford Type B aortic dissection with the Zenith® TXD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zenith® TXD | Device | Zenith® TXD Dissection Stent Graft System for treatment of patients with aortic dissection of the descending thoracic aorta |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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All patients in Japan treated with TXD at investigational sites.
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| Name | Affiliation | Role |
|---|---|---|
| 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 Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kokura Memorial Hospital | Fukuoka | 802-8555 | Japan | |||
| Kyushu University Hospital |
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| ID | Term |
|---|---|
| D000784 | Aortic Dissection |
| D012421 | Rupture |
| D000208 | Acute Disease |
| ID | Term |
|---|---|
| D000094665 | Dissection, Blood Vessel |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Fukuoka |
| 812-8582 |
| Japan |
| Minami Tohoku Hospital | Fukushima | 963-8563 | Japan |
| Iwaki Kyoritsu Hospital | Fukushima | 973-8555 | Japan |
| Hospital Hakodate Hokkaido | Hokkaido | 041-8680 | Japan |
| Steel Memorial Muroran Hospital | Hokkaido | 050-0076 | Japan |
| Hyogo Brain and Heart Center | Hyōgo | 670-0981 | Japan |
| Mie University Hospital | Mie | 514-8507 | Japan |
| Sendai Kousei Hospital | Miyagi | 980-0873 | Japan |
| Shinshu University Hospital | Nagoya | 390-8621 | Japan |
| Tenri Hospital | Nara | 632-8552 | Japan |
| University of the Ryukyus Hospital | Okinawa | 903-0215 | Japan |
| Morinomiya Hospital | Osaka | 536-0025 | Japan |
| Matsubara Tokushukai Hospital | Osaka | 580-0032 | Japan |
| Kinki University Hospital, Faculty of Medicine | Osaka | 589-8511 | Japan |
| Oita University Hospital | Ōita | 879-5593 | Japan |
| Saitama International Medical Center | Saitama | 350-1298 | Japan |
| Dokkyo Medical Univercity Hospital | Tochigi | 321-0293 | Japan |
| Saiseikai Utsunomiya Hospital | Tochigi | 321-0974 | Japan |
| Jikei University School of Medicine | Tokyo | 105-8471 | Japan |
| Tokyo Medical University Hospital | Tokyo | 160-0023 | Japan |
| Keio University Hospital | Tokyo | 160-8582 | Japan |
| Tokyo Women's Medical University Hospital | Tokyo | 162-8666 | Japan |
| Japanese Red Cross Musashino Hospital | Tokyo | 180-8610 | Japan |
| Yamagata Prefectural Central Hospital | Yamagata | 990-2292 | Japan |
| Nihonkai General Hospital | Yamagata | 998-8501 | Japan |
| Yamaguchi Grand Medical Center | Yamaguchi | 747-8511 | Japan |
| D000094683 |
| Acute Aortic Syndrome |
| D001018 | Aortic Diseases |
| D014947 | Wounds and Injuries |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |