Aortic Aneurysm, AbdominalNCT03187522
An European Union (EU) Post-Approval Registry of the TREO® Stent-Graft
A study testing TREO Stent-Graft System in people with Aortic Aneurysm, Abdominal, run by Bolton Medical at 16 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Abdominal
- What is being tested?
- TREO Stent-Graft System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 16 sitesin 7 countries
- Study dates
- 22 Jun 2017to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
16 sites in 7 countries.
16 sites in 7 countries
Belgium3 sites
Imelda Hospital
Bonheiden, 2820
Imeldaziekenhuis
Bonheiden
AZ Sint Blasius
Dendermonde
Germany3 sites
Bonifatius Hospital
Lingen
University Clinic and St. Franziskus Hospital Muenster
Münster, D-48145
University Hospital Tübingen
Tübingen
United Kingdom3 sites
Addenbrooke's Hospital, Cambridge University Hospitals
Cambridge
Manchester Royal Infirmary, Central Manchester University Hospitals
Manchester
John Radcliffe Hospital, Oxford University Hospitals
Oxford
Spain2 sites
Hospital Clinic Barcelona
Barcelona, 08036
Complexo Hospitalario Universitario de Ourense
Ourense
Switzerland2 sites
Centro Vascolare Ticino, Ospedale Regionale di Lugano
Lugano, 6903
Civico, Ospedale Regionale
Lugano
About this study
Official title: 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.
Read the 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).
- Conditions
- Aortic Aneurysm, Abdominal
- Being tested
- TREO Stent-Graft System
- Keywords
- AAA, Abdominal Aortic Aneurysms
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TREO Stent-Graft SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| TREO Stent-Graft | Experimental | Patients who receive a TREO Abdominal Stent-Graft System Receives: Device: TREO Stent-Graft System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aneurysm-related mortality
Measured: 30 days post-procedure
Stroke (excluding transient ischemic attack)
Measured: 30 days post-procedure
Myocardial infarction
Raised cardiac enzymes within 30 days of the procedure
Measured: 30 days post-procedure
Renal failure
Renal failure requiring renal replacement therapy (excluding renal insufficiency)
Measured: 30 days post-procedure
Respiratory failure
excluding chronic obstructive pulmonary disease or pulmonary complications)
Measured: 30 days post-procedure
Paraplegia
(excluding paraparesis)
Measured: 30 days post-procedure
Bowel ischemia
A restriction in blood supply to tissues in the bowels
Measured: 30 days post-procedure
Treated aneurysm rupture
Measured: 30 days post-procedure
Secondary outcomes (5)
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
Measured: 30 days post-procedure
Limb Ischemia
Rate of clinically-evident ischemia, subcategorized by embolism or thrombosis, tabulated by the frequency of major amputation.
Measured: 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.
Measured: 5 years
Vascular access complications
Injuries to vessels as a result of the endovascular procedure.
Measured: 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.
Measured: One year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start22 Jun 2017
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Why it stopped: Post Market Study terminated early due to the launch and subsequent incorporation of the study into the Terumo Aortic Endovascular Registry (TiGER-001).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Aneurysm, AbdominalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bolton Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bolton Medical Espana SLU
- Responsible party
- Sponsor
- Investigators
- Giovanni Torsello, MD, PhD, Principal investigator, Center of Vascular and Endovascular Surgery, Munster University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187522
- Sponsor's protocol ID
- IP-0020-16
- Status last verified
- Jun 2020
- First submitted
- 11 Jun 2017
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An EU Post-Approval Registry of the TREO® Stent-Graft for Patients With Infrarenal Abdominal Aortic Aneurysms
- ClinicalTrials.gov ID
- NCT03187522
- Acronym / sponsor ID
- IP-0020-16
- Conditions
- Aortic Aneurysm, Abdominal
- Keywords
- AAA, Abdominal Aortic Aneurysms
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Post Market Study terminated early due to the launch and subsequent incorporation of the study into the Terumo Aortic Endovascular Registry (TiGER-001).
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Bolton MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Bolton Medical Espana SLU
- Study start
- 22 Jun 2017 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 15 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, multi-center, post-market clinical follow-up, non-randomized registry of patients treated with the TREO stent-graft
| Arm | Type | Receives |
|---|---|---|
| TREO Stent-Graft | Experimental | Device: TREO Stent-Graft SystemPatients who receive a TREO Abdominal Stent-Graft System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TREO Stent-Graft SystemThe 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. | Device | TREO Stent-Graft |
Primary outcome
Aneurysm-related mortality
Time frame: 30 days post-procedure
Stroke (excluding transient ischemic attack)
Time frame: 30 days post-procedure
Myocardial infarction
Time frame: 30 days post-procedure
Raised cardiac enzymes within 30 days of the procedure
Renal failure
Time frame: 30 days post-procedure
Renal failure requiring renal replacement therapy (excluding renal insufficiency)
Respiratory failure
Time frame: 30 days post-procedure
excluding chronic obstructive pulmonary disease or pulmonary complications)
Paraplegia
Time frame: 30 days post-procedure
(excluding paraparesis)
Bowel ischemia
Time frame: 30 days post-procedure
A restriction in blood supply to tissues in the bowels
Treated aneurysm rupture
Time frame: 30 days post-procedure
5 secondary outcomes
Major Adverse Events (MAE) at the follow-up time points
Time frame: 30 days post-procedure
Limb Ischemia
Time frame: 30 days post-procedure
Secondary procedures
Time frame: 5 years
Vascular access complications
Time frame: Vascular access will be evaluated on day of index procedure (implant)
Patient-reported quality of life (QOL)
Time frame: One year follow-up
Results and safety
The study was stopped early (reason given: Post Market Study terminated early due to the launch and subsequent incorporation of the study into the Terumo Aortic Endovascular Registry (TiGER-001).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Torsello, MD, PhD principal investigator
Center of Vascular and Endovascular Surgery, Munster University Hospital
16 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TREO Stent-Graft System in people with Aortic Aneurysm, Abdominal, run by Bolton Medical at 16 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Belgium, Germany, United Kingdom, Netherlands, Spain and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Post Market Study terminated early due to the launch and subsequent incorporation of the study into the Terumo Aortic Endovascular Registry (TiGER-001).). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aneurysm-related mortality (time frame: 30 days post-procedure). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.