Health TrialsbyHealthPanel

Terumo Aortic Global Endovascular Registry

ConditionsAbdominal Aortic AneurysmThoracic Aortic AneurysmSurgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVascutek Ltd.

About this trial

Multi-arm, multi-center, open label, prospective observational registry designed to obtain safety and performance data on the use of CE marked and custom Terumo Aortic endovascular grafts.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Minimum age as per local regulations

Indication for aortic endovascular repair with an approved or CE marked by a Regulatory body or custom-made Terumo Aortic Endovascular graft

Ability to provide informed consent

Willingness to comply with the registry protocol

Disqualifiers

None

Trial population

US ONLY:TEVAR patients treated with a RelayPro Device. Patients requiring urgent or elective endovascular treatment of thoracic aortic aneurysm, pseudoaneurysm, dissection, PAU, transection or IMH. OUS: TEVAR- Patients requiring urgent/elective endovascular treatment of thoracic aortic aneurysm, pseudoaneurysm, dissection, PAU or IMH. Abdominal - EVAR Patients requiring urgent/elective endovascular treatment of infrarenal abdominal aortic aneurysm. Custom Device - FEVAR Patients with a documented thoracic/abdominal pathology suitable for elective treatment using a custom Terumo endovascular device. Ascending/Type A Dissections. Other- Isolated Iliac Artery Aneurysm .Patients requiring urgent or elective endovascular treatment of isolated Iliac Artery Aneurysms. As new indications/devices are approved those may also be captured.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Thoracic

    Device

    Implant of a Relay stent graft system

  • Abdominal

    Device

    Implant with an Anaconda or Treo Stent graft system

  • Custom Device

    Device

    Implant of a Fenestrated device such as Fenestrated Anaconda or Fenestrated TREO, Relay Branch or other customised device

  • Illiac Artery

    Device

    Implant with an Anaconda Iliac leg only

Treatment groups

1,000 Participants
are divided into 4 treatment groups
Group A: Thoracic - TEVAR1 intervention
Group B: Abdominal - EVAR1 intervention
Group C: Custom Device1 intervention
Group D: Other indications1 intervention

Trial outcomes

Primary outcomes

1

Aortic Related Mortality

Defined as any death occurring within 30 days of implant, due to rupture or following any procedure intended to treat the target lesion

Time frame
30 days post implant

Secondary outcomes

1

Technical Success

defined as: Successful delivery of the device through the vasculature (i.e. ability to deliver the implant to the intended location without the need for unanticipated corrective intervention related to delivery). Deployment of the endovascular stent-graft in the planned location with coverage of the target lesion (or entry tear in the case of dissection);Absence of unplanned coverage or aortic branch vessels; Patency of the endovascular stent-graft, absence of device deformations (e.g. kinks, stent eversion, maldeployment, misaligned deployment) requiring unplanned placement of an additional device within the endovascular stentgraft, and;Successful withdrawal (i.e. successful withdrawal of the delivery system, without the need for unanticipated corrective intervention related to withdrawal). Absence of Type Ia, Type Ib, Type IIIa and IIIb endoleak that extends beyond 30 days by confirmatory imaging (CTA, magnetic resonance angiography \[MRA\], or duplex ultrasound).

Time frame
Day 0
2

Composite Clinical Success

defined as the absence of: Target lesion related mortality Type Ia, Ib, IIIa and IIIb endoleak Graft infection Stent patency \<50% Target lesion aortic rupture Conversion to open repair Arrest of the original pathological process (e.g., total aortic diameter expansion \>5 mm in the aorta that has a study endograft, embolization from penetrating ulcer, extension of dissection, false lumen perfusion) or a new aortic pathology as a result of the intervention (e.g., pseudoaneurysm, dissection, intramural hematoma, unintentional adverse dissection septum rupture, stent-graft induced aortic wall injury, new aortobronchial/tracheal or aortoenteric fistula formation)

Time frame
1 year
3

Additional Endpoints

All-cause mortality Safety (MAEs, all related adverse events) Target lesion reintervention, all secondary interventions Device performance based on imaging assessments of all morphological variables (aortic remodeling, all endoleaks, any loss of patency, stent-graft migration, device integrity, etc.)

Time frame
1 year

Other outcomes

1

Patient Outcome measure

• Post-operative return to normal activities - employment, household activities, social life and hobbies (return to normal activities will be recorded at one year visit only)

Time frame
1 Year
2

Health Economics

The following health economic will also be summarized: Total procedure time (mins) Fluoroscopy time (mins) Blood loss (ml) Blood transfusion required (ml) Time in ICU (hours/mins) Time to hospital discharge (days) Total Procedure time (mins) Total anesthesia time (hours) Total Procedure to discharge time (hours/days)

Time frame
From Procedure to 1 Year
3

Health Economics

The following health economic will also be summarized: Arterial access route and type (Percutaneous or Cut down)

Time frame
Day 0
4

Health Economics

The following health economic will also be summarized: Volume of contrast media used Volume of Blood loss Volume of Blood transfusion required

Time frame
Day 0

Sponsors and contacts

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

Vascutek Ltd.

Lead sponsor

Bolton Medical

Collaborator

Source ClinicalTrials.gov
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