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

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

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.

Study Overview

• Status: Terminated
• Conditions: Aortic Aneurysm, Abdominal
• Intervention / Treatment: Device: TREO Stent-Graft System

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).

• Study Type: Interventional
• Enrollment (Actual): 174
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Bonheiden, Belgium, 2820
    • Imelda Hospital
  • Bonheiden, Belgium
    • Imeldaziekenhuis
  • Dendermonde, Belgium
    • AZ Sint Blasius
• Germany
  • Lingen, Germany
    • Bonifatius Hospital
  • Muenster, Germany, D-48145
    • University Clinic and St. Franziskus Hospital Muenster
  • Tübingen, Germany
    • University Hospital Tübingen
• Italy
  • Bolzano, Italy
    • Compensorio Sanitario Bolzano
• Netherlands
  • Groningen, Netherlands
    • UMC Groningen
  • Utrecht, Netherlands
    • UMCU
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic Barcelona
  • Ourense, Spain
    • Complexo Hospitalario Universitario de Ourense
• Switzerland
  • Lugano, Switzerland, 6903
    • Centro Vascolare Ticino, Ospedale Regionale di Lugano
  • Lugano, Switzerland
    • Civico, Ospedale Regionale
• United Kingdom
  • Cambridge, United Kingdom
    • Addenbrooke's Hospital, Cambridge University Hospitals
  • Manchester, United Kingdom
    • Manchester Royal Infirmary, Central Manchester University Hospitals
  • Oxford, United Kingdom
    • John Radcliffe Hospital, Oxford University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TREO Stent-Graft; Patients who receive a TREO Abdominal Stent-Graft System	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aneurysm-related mortality		30 days post-procedure
Stroke (excluding transient ischemic attack)		30 days post-procedure
Myocardial infarction	Raised cardiac enzymes within 30 days of the procedure	30 days post-procedure
Renal failure	Renal failure requiring renal replacement therapy (excluding renal insufficiency)	30 days post-procedure
Respiratory failure	excluding chronic obstructive pulmonary disease or pulmonary complications)	30 days post-procedure
Paraplegia	(excluding paraparesis)	30 days post-procedure
Bowel ischemia	A restriction in blood supply to tissues in the bowels	30 days post-procedure
Treated aneurysm rupture		30 days post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Limb Ischemia	Rate of clinically-evident ischemia, subcategorized by embolism or thrombosis, tabulated by the frequency of major amputation.	30 days post-procedure
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
Vascular access complications	Injuries to vessels as a result of the endovascular procedure.	Vascular access will be evaluated on day of index procedure (implant)
Patient-reported quality of life (QOL)	Health outcomes using the EuroQol Five Dimensions Questionnaire (EQ-5D) standardized EuroQol instrument.	One year follow-up

Collaborators and Investigators

• Sponsor: Bolton Medical
• Collaborators: Bolton Medical Espana SLU
• Investigators: Principal Investigator: Giovanni Torsello, MD, PhD, Center of Vascular and Endovascular Surgery, Munster University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2017
• Primary Completion (Actual): December 30, 2020
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: June 11, 2017
• First Submitted That Met QC Criteria: June 13, 2017
• First Posted (Actual): June 15, 2017

Study Record Updates

• Last Update Posted (Actual): March 3, 2021
• Last Update Submitted That Met QC Criteria: March 1, 2021
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: AAA; Abdominal Aortic Aneurysms
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: IP-0020-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No