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| Name | Class |
|---|---|
| Bolton Medical | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thoracic - TEVAR |
| ||
| Abdominal - EVAR |
| ||
| Custom Device |
| ||
| Other indications | Isolated Iliac Artery Aneurysm (IIAA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thoracic | Device | Implant of a Relay stent graft system |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 30 days post implant |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 1 Year |
| Health Economics |
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.
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michelle Durnan | Contact | +44 141 343 0195 | m.durnan@terumoaortic.com | |
| Sammy Jassal | Contact | +44 141 343 0195 | s.dhaliwal@terumoaortic.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Long Beach Memorial Medical Center | Recruiting | Long Beach | California | 90806 | United States |
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| 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 |
|
| Day 0 |
| 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) | 1 year |
| 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.) | 1 year |
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)
| From Procedure to 1 Year |
| Health Economics | The following health economic will also be summarized: Arterial access route and type (Percutaneous or Cut down) | Day 0 |
| Health Economics | The following health economic will also be summarized: Volume of contrast media used Volume of Blood loss Volume of Blood transfusion required | Day 0 |
| Health Economics | The following health economic will also be summarized: Type of Image fusion technology used Type of Magnet system used | Day 0 |
| University of Colorado Anschutz Medical Campus | Recruiting | Aurora | Colorado | 80045 | United States |
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| UC Health Memorial Hospital Center | Recruiting | Colorado Springs | Colorado | 80909 | United States |
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| Yale University | Recruiting | New Haven | Connecticut | 06520 | United States |
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| MedStar Washington Hospital Center | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
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| University of Florida | Recruiting | Gainesville | Florida | 32610 | United States |
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| Loyola University of Chicago (Loyola) | Recruiting | Chicago | Illinois | 60153 | United States |
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| Ascension St. Vincent Heart Center | Recruiting | Indianapolis | Indiana | 46260 | United States |
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| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| Cooper University Hospital | Recruiting | Camden | New Jersey | 08103 | United States |
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| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| University of Pittsburgh | Recruiting | Pittsburgh | Pennsylvania | 15232 | United States |
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| Ascension Texas Cardiovascular / UT Dell Medical School | Recruiting | Austin | Texas | 78705 | United States |
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| Baylor, Scott & White Health (BSW Health) | Recruiting | Texas City | Texas | 75093 | United States |
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| University of Utah | Recruiting | Salt Lake City | Utah | 84132 | United States |
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| University of Virgina | Recruiting | Charlottesville | Virginia | 22908 | United States |
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| Sentara Heart Hospital | Recruiting | Norfolk | Virginia | 22042 | United States |
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| Imeldaziekenhuis | Recruiting | Bonheiden | Belgium |
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| Clinques Uni. St Lucs | Withdrawn | Brussels | Belgium |
| Hôpital Pneumologique et Cardiovasculaire Louis-Pradel | Recruiting | Bron | France |
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| CHU St Etienne | Recruiting | Saint-Etienne | France |
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| Klinikum Augsburg | Recruiting | Augsburg | Germany |
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| Evangelisches Krankenhaus Hubertus | Recruiting | Berlin | Germany |
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| Klinikum Chemnitz | Recruiting | Chemnitz | Germany |
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| University Heart Center Freiburg | Recruiting | Freiburg im Breisgau | Germany |
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| Aortic Center University Hospital | Withdrawn | Göttingen | Germany |
| Bonifatius Hospital | Recruiting | Lingen | Germany |
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| St. Franziskus Hospital | Recruiting | Münster | Germany |
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| University Hospital Tübingen | Recruiting | Tübingen | Germany |
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| Policlinico Consorziale di Bari | Recruiting | Bari | Italy |
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| Compensorio Sanitario Bolzano | Recruiting | Bolzano | Italy |
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| Cagliari-Ospedale Brotzu | Recruiting | Cagliari | Italy |
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| Firenze Ospedale Careggi | Recruiting | Careggi | Italy |
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| Azienda Ospedaliera di Catania | Recruiting | Catania | Italy |
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| Uni. di Modena | Not yet recruiting | Modena | Italy |
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| Azienda Ospedaliera Universitaria Senese | Recruiting | Siena | Italy |
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| Maurizano Torino (turin) | Recruiting | Turin | Italy |
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| Turin Uni. Hospital | Not yet recruiting | Turin | Italy |
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| Vumc Amsterdam | Recruiting | Amsterdam | Netherlands |
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| Rijnstate Arnham | Recruiting | Arnhem | Netherlands |
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| Medisch Spectrum Twente | Recruiting | Enschede | Netherlands |
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| UMC Gronigen | Recruiting | Groningen | Netherlands |
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| St. Antonius Ziekenhuis | Not yet recruiting | Nieuwegein | 3430 | Netherlands |
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| Erasmus University Medical Center | Recruiting | Rotterdam | Netherlands |
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| Diakonessenhuis | Recruiting | Utrecht | Netherlands |
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| Centro Hospital Uni Lisboa Norte | Recruiting | Lisbon | Portugal |
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| Hospital de Santa Marta | Recruiting | Lisbon | Portugal |
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| CHU Sao Joao | Withdrawn | Porto | Portugal |
| Hospital Universitari Germans | Recruiting | Badalona | Spain |
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| Hospital Clinic i Provincial de Barcelona | Recruiting | Barcelona | Spain |
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| Hospital Universitari Valle Hebrón de Barcelona | Recruiting | Barcelona | Spain |
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| Hospital Universitario Central de Asturias, Oviedo | Recruiting | Oviedo | Spain |
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| Luzerner Kantonsspital | Recruiting | Lucerne | Switzerland |
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| Civico, Ospedale Regionale | Withdrawn | Lugano | Switzerland |
| Royal Derby Hospital | Not yet recruiting | Derby | United Kingdom |
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| Hull Royal Infirmary | Recruiting | Hull | United Kingdom |
|
| Manchester Royal Infirmary | Recruiting | Manchester | United Kingdom |
|
| Oxford University Hospital | Recruiting | Oxford | United Kingdom |
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D017545 | Aortic Aneurysm, Thoracic |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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