Trials Sponsors Conditions Drugs Pricing

Conditions

Aortic Dissection

Keywords

Stanford type B aortic dissectionMalperfusionRuptureAcute diseaseEndovascular 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® TXDDevice

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

Aortic Dissection

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-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

Sponsors & Collaborators

Cook Group Incorporated
Industrylead

Study Sites (27)

Kokura Memorial Hospital

Fukuoka, 802-8555, Japan

Kyushu University Hospital

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

MeSH Terms

Conditions

Aortic DissectionRuptureAcute Disease

Condition Hierarchy (Ancestors)

Dissection, Blood VesselAneurysmVascular DiseasesCardiovascular DiseasesAcute Aortic SyndromeAortic DiseasesWounds and InjuriesDisease AttributesPathologic ProcessesPathological 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

Enrollment

57 participants (actual enrollment reported by the registry).

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 2015

Date type not reported

This date has not been verified as actual or estimated.

Zenith® TXD Post-market Surveillance in Japan

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Aortic Dissection

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (27)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Aortic Dissection

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (27)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations