Abdominal Aortic AneurysmRATIONALENCT03449875
Global Post-market Registry for the Treovance Stent-graft.
An observational study of Abdominal Aortic Aneurysm, run by Bolton Medical at 32 sites in 17 countries.
Trial summary
Patients with abdominal aortic aneurysms (AAA) suitable for endovascular aortic repair (EVAR) with Treovance were eligible to participate. Main inclusion criteria were: age 18-85 years; infrarenal AAA without significant infrarenal or distal iliac landing neck calcification or thrombus formation; infrarenal or distal… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- TREOVANCE® Stent-Graft with Navitel® Delivery System
- Type of treatment
- Medical device
- How many people
- 202 participants
- Where
- 32 sitesin 17 countries
- Study dates
- 5 Feb 2014to 11 Apr 2017
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects diagnosed with infrarenal aortic aneurysms requiring endovascular repair.
Who may be able to join
- Subject must be between the ages of 18 and 85.
- Subject must be diagnosed with an infrarenal abdominal aortic aneurysm (AAA), with or without iliac artery involvement, by CT with contrast performed within 3 months of planned implant procedure.
- Subject must have an infrarenal AAA that i. is > 4.5 cm in diameter for females and > 5 cm for males. ii. has increased in diameter by 0.5 cm in the last 6 months
- Subject must have i. infrarenal landing neck length of 10 mm or greater and an angle of less than 60 degrees relative to the long axis of the aneurysm (centerline at lowest renal to centerline at bifurcation) and a suprarenal neck angle of less than 45 degrees relative to the infrarenal neck axis and an inside diameter of 17 mm - 32 mm, or ii. infrarenal landing neck length of 15 mm or greater and an angle of between 60 and 75 degrees relative to the long axis of the aneurysm and a suprarenal neck angle of less than 45 degrees relative to the infrarenal neck axis and an inside diameter of 16 mm-30 mm
- Subject's infrarenal landing neck must i. have no significant calcification or thrombus formation, and ii. meet the vessel size requirements specified in the instructions for use (IFU) for the corresponding devices
- Subject must have lowest renal artery at least 9 cm from the aortic bifurcation
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- Subject must have a distal iliac landing neck with i. an inside diameter of 7 mm - 13 mm and a length of at least 10 mm, or ii. an inside diameter of >13 mm - 20 mm and a length of at least 15 mm
- Subject's distal iliac landing neck must i. have no significant calcification or thrombus formation, and ii. meet the vessel size requirements specified for the corresponding devices in the IFU
- Subject must have a total treatment length of at least 13 cm
- Subject must be willing and able to comply with 1-month, 6-month, and 12-month follow-up visits.
- Subject must have adequate vascular access (e.g., patent iliac or femoral arteries) for introduction of the Navitel® Delivery System which is 18F (6 mm) or 19F (6.3 mm) outer diameter based on size of device used. Alternatively, subject's anatomy is suitable for creation of an iliac conduit.
- Subject or Legally Authorized Representative (LAR) must agree to sign hospital issued Informed Consent Form
Who cannot join
- Subject is pregnant or lactating
- Subject has a dissection or a ruptured aneurysm (as determined by treating physician).
- Subject has a patent inferior mesenteric artery that cannot be sacrificed and an occluded or stenotic celiac and/or superior mesenteric artery
- Implant procedure as planned does not allow for at least one patent hypogastric artery left intact, unless both are occluded on pre-op imaging
- Subject has a lesion that cannot be crossed by a guide wire
- Proximal neck cannot increase by more than 20% over 15 mm; i.e., no conical necks
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- Subject has severe untreated coronary artery disease and/or unstable angina, significant areas of myocardium at risk (based on coronary angiogram or radionuclide scans), left ventricular ejection fraction < 20%, or recent diagnosis of CHF
- Subject has had a stroke or MI within 6 months of the planned treatment date
- Subject has chronic obstructive pulmonary disease requiring routine need for oxygen therapy outside the hospital setting (e.g., daily or nightly home use)
- Subject has an active systemic infection or is suspected of having an active systemic infection (e.g., AIDS/HIV, sepsis)
- Subject is morbidly obese (more than 100% over the ideal body weight or as defined by institutional standards) or has other clinical conditions that severely compromise or impair x-ray visualization of the aorta
- Subject has significant or circumferential mural thrombus in the proximal aortic neck
- Subject has a blood coagulation disorder or bleeding diathesis the treatment for which cannot be suspended pre- and post-repair
- Subject is in acute or chronic renal failure (creatinine > 2.5 mg/dL)
- Subject has less than two-year life expectancy as evidenced by factors prohibiting major medical intervention (e.g., presence of malignancy, severe cardiopulmonary disease, etc.)
- Subject is participating in another research study, has received investigational study drug within 30 days of planned procedure, or has received an investigational device within one year of planned procedure.
- Subject is confronted with other medical, social or psychological issues that the investigator believes may interfere with study treatment or follow-up. These reasons must be documented. An example may include adherence to a theological or personal doctrine with aversion or opposition to blood transfusion.
- Subject has had a prior AAA repair (endovascular or surgical)
- Subject has an untreatable allergy or sensitivity to contrast media, nitinol/nickel, or polyester
- Subject has undergone other major surgical or medical intervention within 45 days of the planned procedure or is planning to undergo other major surgical or medical intervention within 45 days post implantation (e.g., CABG, organ transplantation, renal stenting, etc.)
Trial locations and contacts
32 sites in 17 countries.
32 sites in 17 countries
Spain5 sites
Hospital HM Modelo
A Coruña
Hospital Germans Trias i Pujol
Badalona
Hospital Clínic de Barcelona
Barcelona
Hospital Universitario Ramón y Cajal
Madrid
Complexo Hospitalario Universitario de Ourense
Ourense
Germany4 sites
Deutsches Herzzentrum Berlin
Berlin
Bonifatius Hospital
Lingen
Theresienkrankenhaus und St. Hedwig-Klinik
Mannheim
Universitätsklinikum Tübingen
Tübingen
Italy3 sites
Casa Di Cura Villa Dei Fiori
Acerra
Azienda Ospedaliera San Camillo Forlanini
Roma
Azienda Ospedaliera Universitaria Senese
Siena
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
Chile2 sites
Hospital Barros Luco Trudeau
Santiago
Hospital de la Dirección de Previsión de Carabineros de Chile
Santiago
Greece2 sites
Evaggelismos General Hospital
Athens
Georgios Gennimatas Thessaloniki General Hospital
Thessaloniki
Netherlands2 sites
ZiekenhuisGroep Twente
Almelo
Universitair Medisch Centrum Utrecht
Utrecht
Sweden2 sites
Linköping University Hospital
Linköping
Karolinska University Hospital
Solna
Denmark1 site
Rigshospitalet, National Hospital and University of Copenhagen
Copenhagen
About this study
Official title: A Post-Market Surveillance Clinical Registry of the TREOVANCE® Stent-Graft for Patients With Infrarenal Abdominal Aortic Aneurysms
Patients with abdominal aortic aneurysms (AAA) suitable for endovascular aortic repair (EVAR) with Treovance were eligible to participate. Main inclusion criteria were: age 18-85 years; infrarenal AAA without significant infrarenal or distal iliac landing neck calcification or thrombus formation; infrarenal or distal iliac landing neck size requirements specified in the instructions for use. Main exclusion criteria: dissection/ruptured aneurysm or prior AAA endovascular or surgical repair. The primary endpoints were standard EVAR criteria.
Read the detailed description
The goal of the registry was to collect clinical data of TREOVANCE® device in subjects with infrarenal aortic aneurysms, specifically to evaluate if the diseased pathology is treated with an acceptable technical success rate, an acceptable complication rate and that the device performs as expected.
The following endovascular measures/parameters were assessed for preliminary performance at the follow-up intervals: delivery/deployment, stent-graft migration, stent-graft patency, stent-graft integrity, endoleak, aneurysm sac size changes, limb ischemia, and vascular access complications.
This registry was a prospective, multi-center, post-market non-randomized study. The goal was to gather safety and performance data on the device. Subjects diagnosed with infrarenal aortic aneurysms enrolled into the registry were treated with the TREOVANCE® Stent-Graft with Navitel® Delivery System. Pre-procedure baseline data was gathered as well as post-procedure assessments prior to hospital discharge and 1, 6, and 12 months post-implantation.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- TREOVANCE® Stent-Graft with Navitel® Delivery System
- 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.
TREOVANCE® Stent-Graft with Navitel® Delivery SystemDevice
Endovascular repair of abdominal aortic aneurysms.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects reporting Major Adverse Events
Primary safety outcome will be assessed by measurement of mortality and major morbidity rates through reporting of the following events:
- Death
- Stroke
- Myocardial Infarction
- Renal Failure requiring renal replacement therapy
- Respiratory Failure, defined as ventilator-dependent
- Paraparesis / Paraplegia (excludes paraparesis)
- Bowel ischemia
- Treated aneurysm rupture
Measured: Through 12 months
Secondary outcomes (9)
Rate of Device Delivery/Deployment Success
Device effectiveness will be measured through the rate of successful delivery and deployment during the index procedure
Measured: Procedure / Study Day 0
Rate of Stent-Graft Migration greater than 10mm
Device effectiveness will be measured by the rate of Stent-Graft Migration greater than 10mm as compared to the first post procedure imaging
Measured: 6 months and 12 months
Rate of Stent-Graft Patency
Device effectiveness will be measured by the rate of Stent-Graft Patency observed
Measured: 1 month, 6 months and 12 months
Rate of Stent-Graft Integrity
Device effectiveness will be measured by the rate of Stent-Graft Integrity observed
Measured: 1 month, 6 months and 12 months
Rate of Endoleaks
Device effectiveness will be measured by the rate of Endoleaks reported
Measured: 1 month, 6 months and 12 months
Rate of Aneurysm Sac Size Changes
Device effectiveness will be measured by the rate of Aneurysm Sac Size Changes at 6 months and 12 months as compared to the first post-procedure imaging
Measured: 6 months and 12 months
Rate of Limb Ischemia
Device effectiveness will be measured by the rate of Limb Ischemia resulting in limb loss
Measured: 1 month, 6 months and 12 months
Rate of Vascular Access Complications
Device effectiveness will be measured by the rate of Vascular Access Complications
Measured: 1 month, 6 months and 12 months
Rate of unintentional covering of renal arteries and / or hypogastric arteries
Device effectiveness will be measured by the rate of unintentional covering of renal arteries and / or hypogastric arteries during the index procedure
Measured: Procedure / Study Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start5 Feb 2014
- Primary completion11 Apr 2017
- Study completion11 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Abdominal Aortic AneurysmStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 202 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Bolton Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlo Setacci, MD, PhD, Study chair, Department of Medicine, Surgery and Neuroscience, University of Siena Viale Bracci 1, 53100 Siena, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03449875
- Sponsor's protocol ID
- IP-0024-17
- Acronym
- RATIONALE
- Status last verified
- Jun 2020
- First submitted
- 9 Jan 2018
- Last updated
- 26 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Murray D, Szeberin Z, Benevento D, Abdallah F, Palasciano G, Lescan M, Uberoi R, Setacci C. A comparison of clinical outcomes of abdominal aortic aneurysm patients with favorable and hostile neck angulation treated by endovascular repair with the Treovance stent graft. J Vasc Surg. 2020 Jun;71(6):1881-1889. doi: 10.1016/j.jvs.2019.07.096. Epub 2019 Nov 2.
PubMed 31690524Uberoi R, Setacci C, Lescan M, Lorido A, Murray D, Szeberin Z, Zubilewicz T, Riambau V, Chartrungsan A, Tessarek J; RATIONALE Investigators. Global Post-Market Clinical Follow-up of the Treovance Stent-Graft for Endovascular Aneurysm Repair: One-Year Results From the RATIONALE Registry. J Endovasc Ther. 2018 Dec;25(6):726-734. doi: 10.1177/1526602818803939. Epub 2018 Oct 3.
PubMed 30280649
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Market Surveillance Clinical Registry of the TREOVANCE® Stent-Graft for Patients With Infrarenal Abdominal Aortic Aneurysms
- ClinicalTrials.gov ID
- NCT03449875
- Acronym / sponsor ID
- RATIONALE / IP-0024-17
- Conditions
- Abdominal Aortic Aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Bolton MedicalIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2014 (actual)
- Primary completion
- 11 Apr 2017 (actual)
- Study completion
- 11 Apr 2017 (actual)
- First posted
- 28 Feb 2018 (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.
Patients with abdominal aortic aneurysms (AAA) suitable for endovascular aortic repair (EVAR) with Treovance were eligible to participate. Main inclusion criteria were: age 18-85 years; infrarenal AAA without significant infrarenal or distal iliac landing neck calcification or thrombus formation; infrarenal or distal iliac landing neck size requirements specified in the instructions for use. Main exclusion criteria: dissection/ruptured aneurysm or prior AAA endovascular or surgical repair. The primary endpoints were standard EVAR criteria.
Detailed description
The goal of the registry was to collect clinical data of TREOVANCE® device in subjects with infrarenal aortic aneurysms, specifically to evaluate if the diseased pathology is treated with an acceptable technical success rate, an acceptable complication rate and that the device performs as expected.
The following endovascular measures/parameters were assessed for preliminary performance at the follow-up intervals: delivery/deployment, stent-graft migration, stent-graft patency, stent-graft integrity, endoleak, aneurysm sac size changes, limb ischemia, and vascular access complications.
This registry was a prospective, multi-center, post-market non-randomized study. The goal was to gather safety and performance data on the device. Subjects diagnosed with infrarenal aortic aneurysms enrolled into the registry were treated with the TREOVANCE® Stent-Graft with Navitel® Delivery System. Pre-procedure baseline data was gathered as well as post-procedure assessments prior to hospital discharge and 1, 6, and 12 months post-implantation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects diagnosed with infrarenal aortic aneurysms requiring endovascular repair.
Key inclusion criteria (12 listed)
- Subject must be between the ages of 18 and 85.
- Subject must be diagnosed with an infrarenal abdominal aortic aneurysm (AAA), with or without iliac artery involvement, by CT with contrast performed within 3 months of planned implant procedure.
- Subject must have an infrarenal AAA that i. is > 4.5 cm in diameter for females and > 5 cm for males. ii. has increased in diameter by 0.5 cm in the last 6 months
- Subject must have i. infrarenal landing neck length of 10 mm or greater and an angle of less than 60 degrees relative to the long axis of the aneurysm (centerline at lowest renal to centerline at bifurcation) and a suprarenal neck angle of less than 45 degrees relative to the infrarenal neck axis and an inside diameter of 17 mm - 32 mm, or ii. infrarenal landing neck length of 15 mm or greater and an angle of between 60 and 75 degrees relative to the long axis of the aneurysm and a suprarenal neck angle of less than 45 degrees relative to the infrarenal neck axis and an inside diameter of 16 mm-30 mm
- Subject's infrarenal landing neck must i. have no significant calcification or thrombus formation, and ii. meet the vessel size requirements specified in the instructions for use (IFU) for the corresponding devices
Key exclusion criteria (20 listed)
- Subject is pregnant or lactating
- Subject has a dissection or a ruptured aneurysm (as determined by treating physician).
- Subject has a patent inferior mesenteric artery that cannot be sacrificed and an occluded or stenotic celiac and/or superior mesenteric artery
- Implant procedure as planned does not allow for at least one patent hypogastric artery left intact, unless both are occluded on pre-op imaging
- Subject has a lesion that cannot be crossed by a guide wire
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 |
|---|---|---|
| TREOVANCE® Stent-Graft with Navitel® Delivery SystemEndovascular repair of abdominal aortic aneurysms. | Device | – |
Primary outcome
Number of subjects reporting Major Adverse Events
Time frame: Through 12 months
Primary safety outcome will be assessed by measurement of mortality and major morbidity rates through reporting of the following events: * Death * Stroke * Myocardial Infarction * Renal Failure requiring renal replacement therapy * Respiratory Failure, defined as ventilator-dependent * Paraparesis / Paraplegia (excludes paraparesis) * Bowel ischemia * Treated aneurysm rupture
9 secondary outcomes
Rate of Device Delivery/Deployment Success
Time frame: Procedure / Study Day 0
Rate of Stent-Graft Migration greater than 10mm
Time frame: 6 months and 12 months
Rate of Stent-Graft Patency
Time frame: 1 month, 6 months and 12 months
Rate of Stent-Graft Integrity
Time frame: 1 month, 6 months and 12 months
Rate of Endoleaks
Time frame: 1 month, 6 months and 12 months
Rate of Aneurysm Sac Size Changes
Time frame: 6 months and 12 months
Rate of Limb Ischemia
Time frame: 1 month, 6 months and 12 months
Rate of Vascular Access Complications
Time frame: 1 month, 6 months and 12 months
Rate of unintentional covering of renal arteries and / or hypogastric arteries
Time frame: Procedure / Study Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
- Derived from this study: PubMed 31690524Murray D, Szeberin Z, Benevento D, Abdallah F, Palasciano G, Lescan M, Uberoi R, Setacci C. A comparison of clinical outcomes of abdominal aortic aneurysm patients with favorable and hostile neck angulation treated by endovascular repair with the Treovance stent graft. J Vasc Surg. 2020 Jun;71(6):1881-1889. doi: 10.1016/j.jvs.2019.07.096. Epub 2019 Nov 2.
- Derived from this study: PubMed 30280649Uberoi R, Setacci C, Lescan M, Lorido A, Murray D, Szeberin Z, Zubilewicz T, Riambau V, Chartrungsan A, Tessarek J; RATIONALE Investigators. Global Post-Market Clinical Follow-up of the Treovance Stent-Graft for Endovascular Aneurysm Repair: One-Year Results From the RATIONALE Registry. J Endovasc Ther. 2018 Dec;25(6):726-734. doi: 10.1177/1526602818803939. Epub 2018 Oct 3.
- Individual participant dataSharing planned: Undecided
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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.
Carlo Setacci, MD, PhD study chair
Department of Medicine, Surgery and Neuroscience, University of Siena Viale Bracci 1, 53100 Siena, Italy
32 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm, run by Bolton Medical at 32 sites in 17 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 12 inclusion and 20 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: finished, as of the sponsor's last update on 26 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Spain, Germany, Italy, United Kingdom, Chile and 12 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of subjects reporting Major Adverse Events (time frame: Through 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03449875, which also lists 2 linked publications.
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 26 Jun 2020.