Clinical trial NCT03187522: An European Union (EU) Post-Approval Registry of the TREO® Stent-Graft
Official title: An EU Post-Approval Registry of the TREO® Stent-Graft for Patients With Infrarenal Abdominal Aortic Aneurysms
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Aortic Aneurysm, Abdominal
Keywords: AAA
Abdominal Aortic Aneurysms
Lead sponsor: Bolton Medical
Sponsor class: INDUSTRY
Collaborators: name: Bolton Medical Espana SLU
First posted: 2017-06-15
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective, multi-center, post-market clinical follow-up, non-randomized registry of patients treated with the TREO stent-graft
Primary purpose: TREATMENT

Brief summary: This is an EU sponsored trial and independent of the US trial registered under Clinicaltrials.gov ID NCT02009644.

The purpose of this registry is to gather clinical data on the safety and performance of the TREO Stent-Graft in patients with infrarenal abdominal aortic aneurysms. The registry is part of TREO's EU post-market surveillance plan providing long-term systematic clinical follow-up.

Detailed description: This is a prospective, multicenter, post-market clinical follow-up, non-randomized registry of the TREO Stent-Graft. Subjects diagnosed with infrarenal aortic aneurysms and treated with the TREO Stent-Graft or TREO aorto-uni-iliac (AUI) device can be included into the registry. Pre-procedure baseline data will be gathered as well as post-procedure assessments prior to hospital discharge and one to three months and 1, 2, 3, 4, and 5-year post-implantation.

The objective of the registry is to assess the clinical results and health economics of the TREO device in a real-world population of patients with infrarenal abdominal aortic aneurysms (AAA).

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Signed informed consent
* Willingness to comply with study follow-up
* Indication for elective endovascular repair
* Planned implantation of single Treo device system or aorto uni-iliac (AUI) device to include any auxiliary device components

Exclusion Criteria:

* Intolerance to contrast media
* Emergency procedure
* Chimneys or fenestrated device procedures
* Connective tissue disease (e.g., Marfan's syndrome)
* High probability of non-adherence to follow-up requirements
* Current participation in a concurrent trial that may confound study results
* Female of childbearing potential in whom pregnancy cannot be excluded
* Previous endovascular or surgical AAA repair

Primary outcomes:
measure: Aneurysm-related mortality
timeFrame: 30 days post-procedure
measure: Stroke (excluding transient ischemic attack)
timeFrame: 30 days post-procedure
measure: Myocardial infarction
timeFrame: 30 days post-procedure
measure: Renal failure
timeFrame: 30 days post-procedure
measure: Respiratory failure
timeFrame: 30 days post-procedure
measure: Paraplegia
timeFrame: 30 days post-procedure
measure: Bowel ischemia
timeFrame: 30 days post-procedure
measure: Treated aneurysm rupture
timeFrame: 30 days post-procedure
Secondary outcomes:
measure: Major Adverse Events (MAE) at the follow-up time points
timeFrame: 30 days post-procedure
measure: Limb Ischemia
timeFrame: 30 days post-procedure
measure: Secondary procedures
timeFrame: 5 years
measure: Vascular access complications
timeFrame: Vascular access will be evaluated on day of index procedure (implant)
measure: Patient-reported quality of life (QOL)
timeFrame: One year follow-up
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Imelda Hospital
city: Bonheiden
country: Belgium
facility: Imeldaziekenhuis
city: Dendermonde
country: Belgium
facility: AZ Sint Blasius
city: Lingen
country: Germany
facility: Bonifatius Hospital
city: Muenster
country: Germany
facility: University Clinic and St. Franziskus Hospital Muenster
city: Tübingen
country: Germany
facility: University Hospital Tübingen
city: Bolzano
country: Italy
facility: Compensorio Sanitario Bolzano
city: Groningen
country: Netherlands
facility: UMC Groningen
city: Utrecht
country: Netherlands
facility: UMCU
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
city: Ourense
country: Spain
facility: Complexo Hospitalario Universitario de Ourense
city: Lugano
country: Switzerland
facility: Centro Vascolare Ticino, Ospedale Regionale di Lugano
city: Lugano
country: Switzerland
facility: Civico, Ospedale Regionale
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital, Cambridge University Hospitals
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary, Central Manchester University Hospitals
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital, Oxford University Hospitals
Study officials:
affiliation: Center of Vascular and Endovascular Surgery, Munster University Hospital
name: Giovanni Torsello, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: