Zenith® TXD Post-market Surveillance in Japan

Aortic Dissection Clinical Trial

Official title:

Zenith TXD Dissection Stent Graft System Usage Results Surveillance in Japan for Treating Acute Complicated Stanford Type B Aortic Dissection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02663739
• Other study ID #: 13-12
• Status: Completed
• Start date: March 2015
• Est. completion date: March 28, 2023

Study information

• Verified date: June 2023
• Source: Cook Group Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: March 28, 2023
• Est. primary completion date: March 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Dissection

Intervention

Device:
• Zenith® TXD
Zenith® TXD Dissection Stent Graft System for treatment of patients with aortic dissection of the descending thoracic aorta

Locations

Country	Name	City	State
Japan	Kokura Memorial Hospital	Fukuoka
Japan	Kyushu University Hospital	Fukuoka
Japan	Iwaki Kyoritsu Hospital	Fukushima
Japan	Minami Tohoku 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	Tenri Hospital	Nara
Japan	Oita University Hospital	Oita
Japan	University of the Ryukyus Hospital	Okinawa
Japan	Kinki University Hospital, Faculty of Medicine	Osaka
Japan	Matsubara Tokushukai Hospital	Osaka
Japan	Morinomiya Hospital	Osaka
Japan	Saitama International Medical Center	Saitama
Japan	Dokkyo Medical Univercity Hospital	Tochigi
Japan	Saiseikai Utsunomiya Hospital	Tochigi
Japan	Japanese Red Cross Musashino Hospital	Tokyo
Japan	Jikei University School of Medicine	Tokyo
Japan	Keio University Hospital	Tokyo
Japan	Tokyo Medical University Hospital	Tokyo
Japan	Tokyo Women's Medical University Hospital	Tokyo
Japan	Nihonkai General Hospital	Yamagata
Japan	Yamagata Prefectural Central Hospital	Yamagata
Japan	Yamaguchi Grand Medical Center	Yamaguchi

Sponsors (1)

Lead Sponsor	Collaborator
Cook Group Incorporated

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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