TBE Zone 2 PMS in Japan

Browse trials for

• Aortic Aneurysm, Thoracic 131
• Aortic Dissection 205
• Wounds and Injuries 2,217

Aortic Aneurysm, Thoracic

131 studies on the registry are indexed under Aortic Aneurysm, Thoracic; 33 are open to participants now.

This study's planned enrollment of 200 is above the median of 154 across 65 observational studies indexed under Aortic Aneurysm, Thoracic.

Lead sponsor

W.L.Gore & Associates is the lead sponsor of 96 studies on the registry; 20 are open to participants now.

Study population

Groups and cohorts

• TBE

  Device: Gore® TAG® Thoracic Aortic Branch Stent Graft System

Interventions

• DeviceGore® TAG® Thoracic Aortic Branch Stent Graft System

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

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

5. Serious Paraplegia

   Paraplegia secondary to spinal cord ischemia reported as a serious adverse event from sites.

   Time frame: 60 Months

6. Serious Paraparesis

   Paraparesis secondary to spinal cord ischemia reported as a serious adverse event from sites.

   Time frame: 60 Months

7. Renal Failure Requiring Dialysis

   Renal failure reported as a serious adverse event by sites and confirmed to require dialysis.

   Time frame: 60 Months

8. Additional Unanticipated Post-procedural Surgical or Interventional Procedure

   Additional unanticipated surgical procedure or endovascular procedure after the initial procedure. Anticipated or unanticipated status will be determined at the discretion of the investigator. Surgical procedures include conversion to thoracotomy, and endovascular procedures includes the placement of devices other than TBE. Endovascular procedures at the access site, lumbar drains for spinal cord ischemia, and procedures to address problems other than the treatment site (such as bare stent placement for intestinal ischemia due to dissection) do not apply.

   Time frame: 60 Months

9. Serious Device-related Ischemia

   Ischemia reported by sites as a serious adverse event determined to be related to the device.

   Time frame: 60 Months

10. Distal Device-related Thromboembolic Serious Adverse Event Requiring Intervention or Surgery

    Device-related ischemic adverse events reported by sites as serious adverse events that required bypass surgery, surgical procedures, or amputation, or that resulted in death.

    Time frame: 60 Months

11. Serious New Dissection

    New events of arterial dissection reported as serious adverse events by sites.

    Time frame: 60 Months

12. Serious Myocardial Infarction

    Myocardial infarction reported as a serious adverse event by the sites.

    Time frame: 60 Months

13. Serious Laryngeal or Phrenic Nerve Injury

    Nerve damage events reported by the sites as serious adverse events that required retreatment.

    Time frame: 60 Months

14. Serious Heart Failure/Hypotension

    Heart failure or hypotension reported as serious adverse events by the sites.

    Time frame: 60 Months

15. Aortic Enlargement in the Region Encompassed by the Initial Lesion

    An increase of 5 mm or more in arterial diameter at the affected area compared to images taken at the first follow-up after initial treatment.

    Time frame: 60 Months

16. Endoleak

    Serious adverse events reported or confirmed by imaging by the sites. The definitions of each type of endoleaks are as follows: * Type I endoleak is defined as a sealing failure at one of the attachment sites of the graft to the vessel wall. Arterial flow therefore leaks alongside the graft and into the perigraft space. * Type Ia: Proximal leak * Type Ib: Distal leak * Type Ic: Inadequate seal at distal landing zone for side branch component * Type II endoleak is defined as retrograde flow from branch arteries arising from the treated segment of the aorta. * Type III endoleak * Type IIIA endoleak : Attachment of aortic components (aortic-aortic). * Type IIIB endoleak : Fabric tear or disruption. * Type IIIC endoleak:: Attachment of aortic component-side-branch or side-branch-side-branch * Type IV endoleak is defined as flow through porous fabric. * Indeterminate : Endoleak detected with unknown source.

    Time frame: 60 Months

17. Loss of Device Integrity

    Defined as any of the following: * Wire fractures identified in the sealing row stents of the aortic component (AC), branch component (SB) or aortic extender (AE). * Stent kinking: Narrowing of the stent graft associated with demonstrable angulation in any of the stent components, with demonstrable flow * Disruption / tears in the graft component of the stent graft * Transient (compression) or permanent stent-graft collapse (invagination) following complete device deployment, resulting in an overall reduction in the aortic or branch vessel luminal diameter. * If the device loses function due to other malfunctions

    Time frame: 60 Months

18. Loss of Aortic or Aortic Branch Patency

    No flow or contrast detected through the implanted aortic or side branch devices or distal CTAG devices after the index endovascular procedure.

    Time frame: 60 Months

19. Migration

    Longitudinal movement of all or part of the device for a distance ≥10 mm, as confirmed by CT scan, relative to anatomical landmarks and device positioning at the first post-operative CT scan.

    Time frame: 60 Months

20. False Lumen Perfusion through the Primary Entry Tear (Dissection Patients only)

    Flow from a proximal aortic source through the primary intimal tear into the aortic false lumen (similar to a Type IA endoleak after treatment of aneurysms).

    Time frame: 60 Months

21. Extension of a Dissection (Proximally or Distally) (Dissection Patients only)

    Among the aortic dissections reported by sites as serious adverse events, those in which proximal or distal progression of the lesion from the initial procedure was confirmed on imaging.

    Time frame: 60 Months

22. False Lumen Status in Treated and Untreated Segments (Dissection Patients only)

    The thrombosis state of the false lumen at the treated and untreated segments at the initial procedure is confirmed using the following three stages. * Patent is defined as flow present throughout the aortic false lumen in the absence of evidence of thrombus. * Partially thrombosed false lumen is defined as clot within the aortic false lumen that has a residual patent flow channel. * Thrombosed false lumen is defined as complete thrombosis of the aortic false lumen.

    Time frame: 60 Months

Individual participant data

Plan to share: No