Abdominal Aortic AneurismNCT03439423
Control Post Endovascular Treatment of Aortic Aneurisms Through Magnetic Resonance and Ultrasound (SAFEVAR)
An observational study of Abdominal Aortic Aneurism, run by IRCCS Policlinico S. Donato at 1 site in Italy.
Trial summary
The aims of this study are to verify non-inferiority of magnetic resonance (MR) without contrast agent associated to color-Doppler ultrasound for the diagnosis of endoleaks after endovascular aortic repair (EVAR), to evaluate both the economical and biological cost-effectiveness of such diagnostic algorithm as an… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurism
- What is being tested?
- CT with contrast agent, MR without contrast agent and Color-Doppler Ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- 9 Mar 2016to 12 Sep 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent endovascular aortic repair
Who may be able to join
- patients older than 18
- informed written consent
- with either thoracic or abdominal aortic endoprosthesis
Who cannot join
- lack of informed written consent
- patients with absolute contraindications to magnetic resonance imaging
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Controllo Dopo Trattamento Endovascolare di Aneurismi Aortici Mediante Risonanza Magnetica Senza Mezzo di Contrasto ed Ecografia Con Color-doppler: Accuratezza Diagnostica, Analisi Costo-efficacia e Impatto Sul Management Del Paziente
The aims of this study are to verify non-inferiority of magnetic resonance (MR) without contrast agent associated to color-Doppler ultrasound for the diagnosis of endoleaks after endovascular aortic repair (EVAR), to evaluate both the economical and biological cost-effectiveness of such diagnostic algorithm as an alternative to computed tomography (CT) with contrast agent, and to analyze its impact on both patients work-flow and infrastructure logistics
Read the detailed description
In this prospective observational study, 250 patients who underwent EVAR will be studied. They will be enrolled after referral for a CT with contrast agent at IRCCS Policlinico San Donato or at ASST Santi Paolo e Carlo. Those with absolute contraindications to RM will be excluded.
All enrolled subjects will undergo MR with contrast agent and color-Doppler ultrasound after CT. Before and after each examination, they will be submitted a questionnaire to evaluate their perception towards the former, and both costs and exposure deriving from such examinations will be evaluated along with patients' responses. Moreover, both CT and MR along with color-Doppler ultrasound will be analyzed with regards to human resources management, operational management, patients' clinical workflow and organization.
All CT examinations will be independently evaluated by two radiologists with 4- and 8-year expertise in thoracic or abdominal CT. Results obtained from CT examinations will be used as a reference standard using the "worst case scenario" method: if either reader reported endoleak, the CT will be considered positive. The more experienced reader will anonymously and randomly repeat CT evaluation after 1 month.
For CMR examinations, a 15-minute protocol will be used on a 1.5-T device. The following sequences will be performed:
- steady state free-precession (true-FISP)
- half-Fourier single shot spin-echo (HASTE) All examinations will be independently and blindly evaluated by the same two radiologists as CT examinations, and they will be considered positive if areas (even smaller than 5 mm) of alterate signal in comparison to surrounding muscle in the same slice are present inside the aneurismatic sac. The more experienced reader will anonymously and randomly repeat CT evaluation after 1 month.
Color-Doppler ultrasound will be performed with a 1-5 MHz probe, by a radiologist with 7-year expertise in aortic ultrasound, blinded to MR and CT results. Ultrasound images will be evaluated both directly and through spectral flow study.
The sample size was calculated assuming an alpha error of 5%, 90% power and 10% endoleak prevalence. In order to prove a negative predictive value of MR without contrast agent and color-Doppler ultrasound not inferior to 90%, 250 patients should be enrolled.
- Conditions
- Abdominal Aortic Aneurism
- Being tested
- CT with contrast agent, MR without contrast agent, Color-Doppler Ultrasound, Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT with contrast agentRadiation
MR without contrast agentDiagnostic test
on 1.5-T unit, with the following sequences:
- steady-state free-precession (true-FISP)
- half-Fourier single shot spin-echo (HASTE)
Color-Doppler UltrasoundDiagnostic test
QuestionnaireOther
regarding their perception of examinations
| Study group | Role | What they receive |
|---|---|---|
| Patients who underwent EVAR | Not described Receives: Radiation: CT with contrast agent; Diagnostic Test: MR without contrast agent; Diagnostic Test: Color-Doppler Ultrasound; Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and negative predictive value
CT exams with contrast agent will be interpreted by 2 independent and blinded radiologists. The results of enhanced CT will be used as reference standard basing to "worst case scenario" method, i.e. it will be considered positive when one or both readers will report the presence of endoleak. Moreover, in the same way, the most expert reader will repeat the reading after 1 month compared to the first reading. Enhanced 1.5-T MRI will be conducted using true-FISP and HASTE sequences.
The same 2 readers will evaluate the exams comparing to the previous CT exams. Images will be considered positive for the presence of endoleak if inside the aneurysmal sac excluded there will be an area of altered signal compared to adjacent muscles displayed in the same layers. The most experienced reader will repeat the exam reading 1 month later.
The 1,5 MHz Color-Doppler ultrasound will be performed by a radiologist with 7 y of experience in vascular ultrasound of the aorta, blinded to the enhanced CT.
Measured: 2 year
Secondary outcomes (6)
Efficacy of the two diagnostic approaches
A systematic review of the literature will be performed and the data will be used to compare the efficacy of the two diagnostic approaches.
Measured: 2 year
Patient's perception
To evaluate and compare the patient's perception of the examination performed (both MR and CT-free MCD and CT), we will use a EuroQoL5 questionnaire. Patients will be asked to complete the questionnaire before and after each survey. Regarding the economic costs, we will compare the main medical costs (equipment, drugs, used devices, personnel, etc.) to complete the two different diagnostic strategies compared.
Measured: 2 year
Economic costs
Regarding the economic costs, we will compare the main medical costs (equipment, drugs, used devices, personnel, etc.) to complete the two different diagnostic strategies compared.
Measured: 2 year
Patient management
To investigate how the introduction of new technologies in the health field questions the traditional organizational dynamics, two treatments will be examined and compared in terms of human resources, operational management of the treatment process, clinical pathway of the patient and organizational structure.
Measured: 2 year
Involvement of professionals
All the professionals involved in the new diagnostic strategy will be interviewed to identify the organizational strengths and weaknesses related to the new diagnostic strategy in order to allow ad-hoc interventions to improve the process.
Measured: 2 year
Patient acceptance and satisfaction
Regarding the level of patient acceptance and satisfaction, a questionnaire will be proposed and, the results will provide important information to identify the strengths and weaknesses of the treatment and to refine the procedure in order to maximize patient satisfaction.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start9 Mar 2016
- Primary completion12 Sep 2022
- Study completion12 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurismStudies of the same condition, open and under way.
- More trials run by IRCCS Policlinico S. DonatoThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Sardanelli, IRCCS Policlinico S. Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03439423
- Sponsor's protocol ID
- SAFEVAR_v02
- Status last verified
- Sep 2022
- First submitted
- 2 Feb 2018
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controllo Dopo Trattamento Endovascolare di Aneurismi Aortici Mediante Risonanza Magnetica Senza Mezzo di Contrasto ed Ecografia Con Color-doppler: Accuratezza Diagnostica, Analisi Costo-efficacia e Impatto Sul Management Del Paziente
- ClinicalTrials.gov ID
- NCT03439423
- Acronym / sponsor ID
- SAFEVAR_v02
- Conditions
- Abdominal Aortic Aneurism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- IRCCS Policlinico S. DonatoUniversity, hospital or other
- Study start
- 9 Mar 2016 (actual)
- Primary completion
- 12 Sep 2022 (actual)
- Study completion
- 12 Sep 2022 (actual)
- First posted
- 20 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.
The aims of this study are to verify non-inferiority of magnetic resonance (MR) without contrast agent associated to color-Doppler ultrasound for the diagnosis of endoleaks after endovascular aortic repair (EVAR), to evaluate both the economical and biological cost-effectiveness of such diagnostic algorithm as an alternative to computed tomography (CT) with contrast agent, and to analyze its impact on both patients work-flow and infrastructure logistics
Detailed description
In this prospective observational study, 250 patients who underwent EVAR will be studied. They will be enrolled after referral for a CT with contrast agent at IRCCS Policlinico San Donato or at ASST Santi Paolo e Carlo. Those with absolute contraindications to RM will be excluded.
All enrolled subjects will undergo MR with contrast agent and color-Doppler ultrasound after CT. Before and after each examination, they will be submitted a questionnaire to evaluate their perception towards the former, and both costs and exposure deriving from such examinations will be evaluated along with patients' responses. Moreover, both CT and MR along with color-Doppler ultrasound will be analyzed with regards to human resources management, operational management, patients' clinical workflow and organization.
All CT examinations will be independently evaluated by two radiologists with 4- and 8-year expertise in thoracic or abdominal CT. Results obtained from CT examinations will be used as a reference standard using the "worst case scenario" method: if either reader reported endoleak, the CT will be considered positive. The more experienced reader will anonymously and randomly repeat CT evaluation after 1 month.
For CMR examinations, a 15-minute protocol will be used on a 1.5-T device. The following sequences will be performed:
- steady state free-precession (true-FISP)
- half-Fourier single shot spin-echo (HASTE) All examinations will be independently and blindly evaluated by the same two radiologists as CT examinations, and they will be considered positive if areas (even smaller than 5 mm) of alterate signal in comparison to surrounding muscle in the same slice are present inside the aneurismatic sac. The more experienced reader will anonymously and randomly repeat CT evaluation after 1 month.
Color-Doppler ultrasound will be performed with a 1-5 MHz probe, by a radiologist with 7-year expertise in aortic ultrasound, blinded to MR and CT results. Ultrasound images will be evaluated both directly and through spectral flow study.
The sample size was calculated assuming an alpha error of 5%, 90% power and 10% endoleak prevalence. In order to prove a negative predictive value of MR without contrast agent and color-Doppler ultrasound not inferior to 90%, 250 patients should be enrolled.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who underwent EVAR | – | Radiation: CT with contrast agent, Diagnostic Test: MR without contrast agent, Diagnostic Test: Color-Doppler Ultrasound, Other: Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent endovascular aortic repair
Key inclusion criteria (3 listed)
- patients older than 18
- informed written consent
- with either thoracic or abdominal aortic endoprosthesis
Key exclusion criteria (2 listed)
- lack of informed written consent
- patients with absolute contraindications to magnetic resonance imaging
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 |
|---|---|---|
| CT with contrast agent | Radiation | Patients who underwent EVAR |
| MR without contrast agenton 1.5-T unit, with the following sequences: * steady-state free-precession (true-FISP) * half-Fourier single shot spin-echo (HASTE) | Diagnostic test | Patients who underwent EVAR |
| Color-Doppler Ultrasound | Diagnostic test | Patients who underwent EVAR |
| Questionnaireregarding their perception of examinations | Other | Patients who underwent EVAR |
Primary outcome
Sensitivity and negative predictive value
Time frame: 2 year
CT exams with contrast agent will be interpreted by 2 independent and blinded radiologists. The results of enhanced CT will be used as reference standard basing to "worst case scenario" method, i.e. it will be considered positive when one or both readers will report the presence of endoleak. Moreover, in the same way, the most expert reader will repeat the reading after 1 month compared to the first reading. Enhanced 1.5-T MRI will be conducted using true-FISP and HASTE sequences. The same 2 readers will evaluate the exams comparing to the previous CT exams. Images will be considered positive for the presence of endoleak if inside the aneurysmal sac excluded there will be an area of altered signal compared to adjacent muscles displayed in the same layers. The most experienced reader will repeat the exam reading 1 month later. The 1,5 MHz Color-Doppler ultrasound will be performed by a radiologist with 7 y of experience in vascular ultrasound of the aorta, blinded to the enhanced CT.
6 secondary outcomes
Efficacy of the two diagnostic approaches
Time frame: 2 year
Patient's perception
Time frame: 2 year
Economic costs
Time frame: 2 year
Patient management
Time frame: 2 year
Involvement of professionals
Time frame: 2 year
Patient acceptance and satisfaction
Time frame: 2 year
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 13 Sep 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurism, run by IRCCS Policlinico S. Donato at 1 site in Italy.
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 3 inclusion and 2 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 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Sensitivity and negative predictive value (time frame: 2 year). 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 13 Sep 2022.