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

Primary Purpose

Aortic Aneurysm, Abdominal

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
TREO Stent-Graft System
Sponsored by
Bolton Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Aneurysm, Abdominal focused on measuring AAA, Abdominal Aortic Aneurysms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Imelda Hospital
  • Imeldaziekenhuis
  • AZ Sint Blasius
  • Bonifatius Hospital
  • University Clinic and St. Franziskus Hospital Muenster
  • University Hospital Tübingen
  • Compensorio Sanitario Bolzano
  • UMC Groningen
  • UMCU
  • Hospital Clinic Barcelona
  • Complexo Hospitalario Universitario de Ourense
  • Centro Vascolare Ticino, Ospedale Regionale di Lugano
  • Civico, Ospedale Regionale
  • Addenbrooke's Hospital, Cambridge University Hospitals
  • Manchester Royal Infirmary, Central Manchester University Hospitals
  • John Radcliffe Hospital, Oxford University Hospitals

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TREO Stent-Graft

Arm Description

Patients who receive a TREO Abdominal Stent-Graft System

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Limb Ischemia
Rate of clinically-evident ischemia, subcategorized by embolism or thrombosis, tabulated by the frequency of major amputation.
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.
Vascular access complications
Injuries to vessels as a result of the endovascular procedure.
Patient-reported quality of life (QOL)
Health outcomes using the EuroQol Five Dimensions Questionnaire (EQ-5D) standardized EuroQol instrument.

Full Information

First Posted
June 11, 2017
Last Updated
March 1, 2021
Sponsor
Bolton Medical
Collaborators
Bolton Medical Espana SLU
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1. Study Identification

Unique Protocol Identification Number
NCT03187522
Brief Title
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

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Terminated
Why Stopped
Post Market Study terminated early due to the launch and subsequent incorporation of the study into the Terumo Aortic Endovascular Registry (TiGER-001).
Study Start Date
June 22, 2017 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bolton Medical
Collaborators
Bolton Medical Espana SLU

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm, Abdominal
Keywords
AAA, Abdominal Aortic Aneurysms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a prospective, multi-center, post-market clinical follow-up, non-randomized registry of patients treated with the TREO stent-graft
Masking
None (Open Label)
Allocation
N/A
Enrollment
174 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TREO Stent-Graft
Arm Type
Experimental
Arm Description
Patients who receive a TREO Abdominal Stent-Graft System
Intervention Type
Device
Intervention Name(s)
TREO Stent-Graft System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Aneurysm-related mortality
Time Frame
30 days post-procedure
Title
Stroke (excluding transient ischemic attack)
Time Frame
30 days post-procedure
Title
Myocardial infarction
Description
Raised cardiac enzymes within 30 days of the procedure
Time Frame
30 days post-procedure
Title
Renal failure
Description
Renal failure requiring renal replacement therapy (excluding renal insufficiency)
Time Frame
30 days post-procedure
Title
Respiratory failure
Description
excluding chronic obstructive pulmonary disease or pulmonary complications)
Time Frame
30 days post-procedure
Title
Paraplegia
Description
(excluding paraparesis)
Time Frame
30 days post-procedure
Title
Bowel ischemia
Description
A restriction in blood supply to tissues in the bowels
Time Frame
30 days post-procedure
Title
Treated aneurysm rupture
Time Frame
30 days post-procedure
Secondary Outcome Measure Information:
Title
Major Adverse Events (MAE) at the follow-up time points
Description
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
Time Frame
30 days post-procedure
Title
Limb Ischemia
Description
Rate of clinically-evident ischemia, subcategorized by embolism or thrombosis, tabulated by the frequency of major amputation.
Time Frame
30 days post-procedure
Title
Secondary procedures
Description
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.
Time Frame
5 years
Title
Vascular access complications
Description
Injuries to vessels as a result of the endovascular procedure.
Time Frame
Vascular access will be evaluated on day of index procedure (implant)
Title
Patient-reported quality of life (QOL)
Description
Health outcomes using the EuroQol Five Dimensions Questionnaire (EQ-5D) standardized EuroQol instrument.
Time Frame
One year follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanni Torsello, MD, PhD
Organizational Affiliation
Center of Vascular and Endovascular Surgery, Munster University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imelda Hospital
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
Imeldaziekenhuis
City
Bonheiden
Country
Belgium
Facility Name
AZ Sint Blasius
City
Dendermonde
Country
Belgium
Facility Name
Bonifatius Hospital
City
Lingen
Country
Germany
Facility Name
University Clinic and St. Franziskus Hospital Muenster
City
Muenster
ZIP/Postal Code
D-48145
Country
Germany
Facility Name
University Hospital Tübingen
City
Tübingen
Country
Germany
Facility Name
Compensorio Sanitario Bolzano
City
Bolzano
Country
Italy
Facility Name
UMC Groningen
City
Groningen
Country
Netherlands
Facility Name
UMCU
City
Utrecht
Country
Netherlands
Facility Name
Hospital Clinic Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Complexo Hospitalario Universitario de Ourense
City
Ourense
Country
Spain
Facility Name
Centro Vascolare Ticino, Ospedale Regionale di Lugano
City
Lugano
ZIP/Postal Code
6903
Country
Switzerland
Facility Name
Civico, Ospedale Regionale
City
Lugano
Country
Switzerland
Facility Name
Addenbrooke's Hospital, Cambridge University Hospitals
City
Cambridge
Country
United Kingdom
Facility Name
Manchester Royal Infirmary, Central Manchester University Hospitals
City
Manchester
Country
United Kingdom
Facility Name
John Radcliffe Hospital, Oxford University Hospitals
City
Oxford
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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