Abdominal Aortic Aneurysm, Surgery, Thoracic Aortic Aneurysm
Conditions
Brief summary
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.
Detailed description
Post Market registry collecting real world, post-approval safety, performance, patient reported outcomes and health economic data on patients treated with Terumo Aortic endovascular stent-grafts in standard clinical practice.
Interventions
DEVICEThoracic
Implant of a Relay stent graft system
DEVICEAbdominal
Implant with an Anaconda or Treo Stent graft system
DEVICECustom Device
Implant of a Fenestrated device such as Fenestrated Anaconda or Fenestrated TREO, Relay Branch or other customised device
DEVICEIlliac Artery
Implant with an Anaconda Iliac leg only
Sponsors
Vascutek Ltd.
Bolton Medical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 o Emergent cases (typically younger patients with traumatic injuries) are not excluded if there is IRB/EC agreement to allow consent after intervention (i.e. consent to study participation, not to treatment) or use of a Legally Authorized Representative (LAR). * Willingness to comply with the registry protocol * Willingness to adhere to follow-up visits Note: Patients currently enrolled and actively participating within the TREO registry (IP-0020-16) can have their data migrated from TREO to the TiGER registry where local EC approval has been obtained and the patient has been reconsented to TiGER for longer follow-up.
Exclusion criteria
Patient is unable or unwilling to comply with the study follow-up regime. Patient is contraindicated per the IFU, or has any other medical, social or psychological problems that in the opinion of the investigator preclude them from receiving treatment as well as the procedures and evaluations pre and post procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aortic Related Mortality | 30 days post implant | Defined as any death occurring within 30 days of implant, due to rupture or following any procedure intended to treat the target lesion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success | Day 0 | 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). |
| Composite Clinical Success | 1 year | 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) |
| Additional Endpoints | 1 year | 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.) |
Countries
Belgium, France, Germany, Italy, Netherlands, Portugal, Spain, Switzerland, United Kingdom, United States
Contacts
CONTACTMichelle Durnan
CONTACTSammy Jassal
Outcome results
None listed