TBE Zone 2 PMS in Japan

Primary outcomes

1. Device Technical Success at the Initial Procedure

   Time frame: 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

2. Aortic Rupture of the Treatment Lesion

   Time frame: 60 Months

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

3. Lesion-related Mortality and All-cause Death

   Time frame: 60 Months

   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.

4. Disable Stroke

   Time frame: 60 Months

   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

5. Serious Paraplegia

   Time frame: 60 Months

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

6. Serious Paraparesis

   Time frame: 60 Months

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

7. Renal Failure Requiring Dialysis

   Time frame: 60 Months

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

8. Additional Unanticipated Post-procedural Surgical or Interventional Procedure

   Time frame: 60 Months

   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.

9. Serious Device-related Ischemia

   Time frame: 60 Months

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

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

    Time frame: 60 Months

    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.

11. Serious New Dissection

    Time frame: 60 Months

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

12. Serious Myocardial Infarction

    Time frame: 60 Months

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

13. Serious Laryngeal or Phrenic Nerve Injury

    Time frame: 60 Months

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

14. Serious Heart Failure/Hypotension

    Time frame: 60 Months

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

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

    Time frame: 60 Months

    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.

16. Endoleak

    Time frame: 60 Months

    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.

17. Loss of Device Integrity

    Time frame: 60 Months

    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

18. Loss of Aortic or Aortic Branch Patency

    Time frame: 60 Months

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

19. Migration

    Time frame: 60 Months

    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.

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

    Time frame: 60 Months

    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).

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

    Time frame: 60 Months

    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.

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

    Time frame: 60 Months

    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.