Clinical trial NCT02663739: Zenith® TXD Post-market Surveillance in Japan
Official title: Zenith TXD Dissection Stent Graft System Usage Results Surveillance in Japan for Treating Acute Complicated Stanford Type B Aortic Dissection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Dissection
Keywords: Stanford type B aortic dissection
Malperfusion
Rupture
Acute disease
Endovascular procedures
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2016-01-26
Enrollment: 57
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients in Japan treated with TXD at investigational sites.

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


Eligibility criteria: 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

Primary outcomes:
measure: Rate of major adverse events
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Kokura Memorial Hospital
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Fukushima
country: Japan
facility: Minami Tohoku Hospital
city: Fukushima
country: Japan
facility: Iwaki Kyoritsu Hospital
city: Hokkaido
country: Japan
facility: Hospital Hakodate Hokkaido
city: Hokkaido
country: Japan
facility: Steel Memorial Muroran Hospital
city: Hyogo
country: Japan
facility: Hyogo Brain and Heart Center
city: Mie
country: Japan
facility: Mie University Hospital
city: Miyagi
country: Japan
facility: Sendai Kousei Hospital
city: Nagoya
country: Japan
facility: Shinshu University Hospital
city: Nara
country: Japan
facility: Tenri Hospital
city: Oita
country: Japan
facility: Oita University Hospital
city: Okinawa
country: Japan
facility: University of the Ryukyus Hospital
city: Osaka
country: Japan
facility: Morinomiya Hospital
city: Osaka
country: Japan
facility: Matsubara Tokushukai Hospital
city: Osaka
country: Japan
facility: Kinki University Hospital, Faculty of Medicine
city: Saitama
country: Japan
facility: Saitama International Medical Center
city: Tochigi
country: Japan
facility: Dokkyo Medical Univercity Hospital
city: Tochigi
country: Japan
facility: Saiseikai Utsunomiya Hospital
city: Tokyo
country: Japan
facility: Jikei University School of Medicine
city: Tokyo
country: Japan
facility: Tokyo Medical University Hospital
city: Tokyo
country: Japan
facility: Keio University Hospital
city: Tokyo
country: Japan
facility: Tokyo Women's Medical University Hospital
city: Tokyo
country: Japan
facility: Japanese Red Cross Musashino Hospital
city: Yamagata
country: Japan
facility: Yamagata Prefectural Central Hospital
city: Yamagata
country: Japan
facility: Nihonkai General Hospital
city: Yamaguchi
country: Japan
facility: Yamaguchi Grand Medical Center
Study officials:
affiliation: Morinomiya Hospital
name: Masaaki Kato, MD
role: STUDY_CHAIR
affiliation: Nara Medical University Hospital
name: Kimihiko Kichikawa, MD
role: STUDY_CHAIR
affiliation: Keio University Hospital
name: Hideyuki Shimizu, MD
role: STUDY_CHAIR
affiliation: The Cooper Health System
name: Joseph Lombardi, MD
role: STUDY_CHAIR
References: