Health TrialsbyHealthPanel

TBE Zone 2 PMS in Japan

ConditionsAneurysm ThoracicDissection of Aorta, ThoracicTrauma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorW.L.Gore & Associates

About this trial

The goal of this surveillance is to confirm the TBE device's safety and efficacy in patients treated with proximal landing in Zone 2 in the post-marketing period.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Those who are suitable for use of TBE according to the Japan package insert.

Thoracic aortic aneurysm,

Traumatic transection, and

Complicated Stanford type B aortic dissection (including dissecting aortic aneurysm) who have not responded to medical therapy.

Disqualifiers

N/A

Trial population

Patients who attempted implant of TBE in Zone 2 during the enrollment period of this surveillance.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Gore® TAG® Thoracic Aortic Branch Stent Graft System

    Device

    Patients who attempted implant of TBE in Zone 2 during the enrollment period of this surveillance.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: TBE1 intervention

Trial outcomes

Primary outcomes

1

Device Technical Success at the Initial Procedure

All of the following must be met. * Successful access and delivery * Patency of devices * The absence of unanticipated additional procedure related to the device, procedure, or withdrawal of the delivery system

Time frame
Initial procedure
2

Aortic Rupture of the Treatment Lesion

Rupture in the treated segment of the vessel (e.g., aorta or branch) verified with direct observation or CT / CTA scan.

Time frame
60 Months
3

Lesion-related Mortality and All-cause Death

Lesion-related Mortality definition Deaths that meet any of the following criteria: * All deaths within 30 days after the initial procedure during the initial hospitalization or secondary procedures resulting from the treated lesion or endovascular treatment (e.g., procedures for retrograde dissection, loss of patency, loss of device integrity, endoleak, migration, aortic dilation, aneurysm rupture) * All deaths related to the treated lesion or device (e.g., aneurysm rupture, retrograde dissection resulting in fatal cardiac tamponade) Not applicable if there is evidence to support no relationship to the lesion.

Time frame
60 Months
4

Disable Stroke

Stroke is the acute onset of symptoms consistent with focal or multifocal central nervous system (CNS) injury caused by vascular blockage resulting in ischemia or vascular rupture resulting in hemorrhage, that: Persists for \> 24 hours or until death

Time frame
60 Months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

W.L.Gore & Associates

Lead sponsor

CMIC Co, Ltd. Japan

Collaborator

Source ClinicalTrials.gov
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