Zenith® TXD Post-market Surveillance in Japan

NCT02663739 | Completed

• 1 other identifier: 13-12
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 27

Brief Summary

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

Conditions

Aortic Dissection

Keywords

Stanford type B aortic dissection; Malperfusion; Rupture; Acute disease; Endovascular procedures

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Aortic Dissection

Treating patients with acute complicated Stanford Type B aortic dissection with the Zenith® TXD

Device: Zenith® TXD

Interventions

Zenith® TXD DEVICE

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

Aortic Dissection

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients in Japan treated with TXD at investigational sites.

You may qualify if:

• Patients with thoracic aortic dissection, including attempted cases
• Patients with acute Stanford type B aortic dissection, including attempted cases

You may not qualify if:

• Stanford type A aortic dissection and/or chronic type B aortic dissection

Sponsors & Collaborators

• Cook Group Incorporated: lead

Study Sites (27)

Kokura Memorial Hospital

Fukuoka, 802-8555, Japan

Location

Kyushu University Hospital

Fukuoka, 812-8582, Japan

Location

Minami Tohoku Hospital

Fukushima, 963-8563, Japan

Location

Iwaki Kyoritsu Hospital

Fukushima, 973-8555, Japan

Location

Hospital Hakodate Hokkaido

Hokkaido, 041-8680, Japan

Location

Steel Memorial Muroran Hospital

Hokkaido, 050-0076, Japan

Location

Hyogo Brain and Heart Center

Hyōgo, 670-0981, Japan

Location

Mie University Hospital

Mie, 514-8507, Japan

Location

Sendai Kousei Hospital

Miyagi, 980-0873, Japan

Location

Shinshu University Hospital

Nagoya, 390-8621, Japan

Location

Tenri Hospital

Nara, 632-8552, Japan

Location

University of the Ryukyus Hospital

Okinawa, 903-0215, Japan

Location

Morinomiya Hospital

Osaka, 536-0025, Japan

Location

Matsubara Tokushukai Hospital

Osaka, 580-0032, Japan

Location

Kinki University Hospital, Faculty of Medicine

Osaka, 589-8511, Japan

Location

Oita University Hospital

Ōita, 879-5593, Japan

Location

Saitama International Medical Center

Saitama, 350-1298, Japan

Location

Dokkyo Medical Univercity Hospital

Tochigi, 321-0293, Japan

Location

Saiseikai Utsunomiya Hospital

Tochigi, 321-0974, Japan

Location

Jikei University School of Medicine

Tokyo, 105-8471, Japan

Location

Tokyo Medical University Hospital

Tokyo, 160-0023, Japan

Location

Keio University Hospital

Tokyo, 160-8582, Japan

Location

Tokyo Women's Medical University Hospital

Tokyo, 162-8666, Japan

Location

Japanese Red Cross Musashino Hospital

Tokyo, 180-8610, Japan

Location

Yamagata Prefectural Central Hospital

Yamagata, 990-2292, Japan

Location

Nihonkai General Hospital

Yamagata, 998-8501, Japan

Location

Yamaguchi Grand Medical Center

Yamaguchi, 747-8511, Japan

Location

MeSH Terms

Conditions

Aortic Dissection; Rupture; Acute Disease

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases; Wounds and Injuries; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2016
• First Posted: January 26, 2016
• Study Start: March 1, 2015
• Primary Completion: March 28, 2023
• Study Completion: March 28, 2023
• Last Updated: June 7, 2023

Record last verified: 2023-06

Locations

JP (27)