An European Union (EU) Post-Approval Registry of the TREO® Stent-Graft

Aortic Aneurysm, Abdominal Clinical Trial

Official title:

An EU Post-Approval Registry of the TREO® Stent-Graft for Patients With Infrarenal Abdominal Aortic Aneurysms

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03187522
• Other study ID #: IP-0020-16
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

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