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

March 1, 2021 updated by: Bolton Medical

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
174

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Aneurysm-related mortality
Time Frame: 30 days post-procedure
30 days post-procedure
Stroke (excluding transient ischemic attack)
Time Frame: 30 days post-procedure
30 days post-procedure
Myocardial infarction
Time Frame: 30 days post-procedure
Raised cardiac enzymes within 30 days of the procedure
30 days post-procedure
Renal failure
Time Frame: 30 days post-procedure
Renal failure requiring renal replacement therapy (excluding renal insufficiency)
30 days post-procedure
Respiratory failure
Time Frame: 30 days post-procedure
excluding chronic obstructive pulmonary disease or pulmonary complications)
30 days post-procedure
Paraplegia
Time Frame: 30 days post-procedure
(excluding paraparesis)
30 days post-procedure
Bowel ischemia
Time Frame: 30 days post-procedure
A restriction in blood supply to tissues in the bowels
30 days post-procedure
Treated aneurysm rupture
Time Frame: 30 days post-procedure
30 days post-procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Major Adverse Events (MAE) at the follow-up time points
Time Frame: 30 days post-procedure
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
Time Frame: 30 days post-procedure
Rate of clinically-evident ischemia, subcategorized by embolism or thrombosis, tabulated by the frequency of major amputation.
30 days post-procedure
Secondary procedures
Time Frame: 5 years
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
Time Frame: Vascular access will be evaluated on day of index procedure (implant)
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)
Time Frame: One year follow-up
Health outcomes using the EuroQol Five Dimensions Questionnaire (EQ-5D) standardized EuroQol instrument.
One year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bolton Medical

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bolton Medical Espana SLU

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Giovanni Torsello, MD, PhD, Center of Vascular and Endovascular Surgery, Munster University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 22, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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