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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03187522
Other study ID # IP-0020-16
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date June 22, 2017
Est. completion date December 30, 2020

Study information

Verified date June 2020
Source Bolton Medical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Terminated
Enrollment 174
Est. completion date December 30, 2020
Est. primary completion date December 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
TREO Stent-Graft System
The TREO® Stent-Graft is designed for use in the management of patients with AAAs and is composed of self-expanding nitinol stents sutured to polyester vascular graft fabric.

Locations

Country Name City State
Belgium Imelda Hospital Bonheiden
Belgium Imeldaziekenhuis Bonheiden
Belgium AZ Sint Blasius Dendermonde
Germany Bonifatius Hospital Lingen
Germany University Clinic and St. Franziskus Hospital Muenster Muenster
Germany University Hospital Tübingen Tübingen
Italy Compensorio Sanitario Bolzano Bolzano
Netherlands UMC Groningen Groningen
Netherlands UMCU Utrecht
Spain Hospital Clinic Barcelona Barcelona
Spain Complexo Hospitalario Universitario de Ourense Ourense
Switzerland Centro Vascolare Ticino, Ospedale Regionale di Lugano Lugano
Switzerland Civico, Ospedale Regionale Lugano
United Kingdom Addenbrooke's Hospital, Cambridge University Hospitals Cambridge
United Kingdom Manchester Royal Infirmary, Central Manchester University Hospitals Manchester
United Kingdom John Radcliffe Hospital, Oxford University Hospitals Oxford

Sponsors (2)

Lead Sponsor Collaborator
Bolton Medical Bolton Medical Espana SLU

Countries where clinical trial is conducted

Belgium,  Germany,  Italy,  Netherlands,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Aneurysm-related mortality 30 days post-procedure
Primary Stroke (excluding transient ischemic attack) 30 days post-procedure
Primary Myocardial infarction Raised cardiac enzymes within 30 days of the procedure 30 days post-procedure
Primary Renal failure Renal failure requiring renal replacement therapy (excluding renal insufficiency) 30 days post-procedure
Primary Respiratory failure excluding chronic obstructive pulmonary disease or pulmonary complications) 30 days post-procedure
Primary Paraplegia (excluding paraparesis) 30 days post-procedure
Primary Bowel ischemia A restriction in blood supply to tissues in the bowels 30 days post-procedure
Primary Treated aneurysm rupture 30 days post-procedure
Secondary Major Adverse Events (MAE) at the follow-up time points MAE includes any of the following : Aneurysm-related mortality, Stroke (excluding transient ischemic attack), Myocardial infarction, Renal failure requiring renal replacement therapy (excluding renal insufficiency), Respiratory failure (excluding chronic obstructive pulmonary disease or pulmonary complications), Paraplegia (excluding paraparesis), Bowel ischemia, Treated aneurysm rupture 30 days post-procedure
Secondary Limb Ischemia Rate of clinically-evident ischemia, subcategorized by embolism or thrombosis, tabulated by the frequency of major amputation. 30 days post-procedure
Secondary Secondary procedures Freedom from aneurysm-related secondary procedures through five years follow-up. A questionnaire will be conducted. Investigators are required to conduct a lesion and device assessment at each follow-up visit. All secondary procedures reported will be treated descriptively in terms of results. 5 years
Secondary Vascular access complications Injuries to vessels as a result of the endovascular procedure. Vascular access will be evaluated on day of index procedure (implant)
Secondary Patient-reported quality of life (QOL) Health outcomes using the EuroQol Five Dimensions Questionnaire (EQ-5D) standardized EuroQol instrument. One year follow-up
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