Visceral Artery AneurysmE-VisARNCT06913530
European Multicentre Study of Long-term Results Following Visceral Arteries Revascularization: the E-VisAR Study
An observational study of Visceral Artery Aneurysm and Mesenteric Artery Ischemia, run by Azienda Ospedaliero-Universitaria di Modena.
Trial summary
Visceral arteries pathologies are a broad-spectrum of conditions with an extremely low incidence, estimated at 9.2% and 6.2% per 100,000 inhabitants for chronic and acute mesenteric ischemia, respectively, and 0.01-0.2% for aneurysms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Visceral Artery Aneurysm, Mesenteric Artery Ischemia, Renal Artery Aneurysm
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 1 Jun 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Starting from the study launch, all patients with indication for visceral vessel revascularization will be referred to the study staff for enrollment in the prospective cohort. Assessment of the patient will be performed by a vascular surgeon being part of the Medical Staff. After revascularization, clinical and imaging outcomes will be evaluated at short- (within one year), mid- (three-five years), and long-term (> five years) follow-up. For the retrospective cohort, patients' enrollment eligibility (inclusion/exclusion criteria are listed below) and anamnestic, clinical, and morphological data will be reviewed and collected. Data collection for the retrospective cohort will include all eligible patients who have undergone visceral vessels revascularization up to 20 years from the study launch and regardless of the follow-up time. The two cohorts will be independently followed during the study period.
Who may be able to join
- Patients presenting with atherosclerotic disease, aneurysms, or dissection;
- Pathologies involving one or more visceral vessels (celiac, mesenteric, renal arteries, and their branches);
- Patients receiving revascularization, both surgical and endovascular, in elective and urgent/emergent settings;
- For the retrospective cohort, patients who underwent revascularization up to 20 years from the study launch regardless of the follow-up time.
Who cannot join
- Absence of follow-up imaging available and/or reported in follow-up medical reports;
- For the retrospective cohort, a follow-up shorter than three years.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Visceral arteries pathologies are a broad-spectrum of conditions with an extremely low incidence, estimated at 9.2% and 6.2% per 100,000 inhabitants for chronic and acute mesenteric ischemia, respectively, and 0.01-0.2% for aneurysms. The literature regarding the topic is limited in number and fragmented, having multiple vessels involved along with rare conditions caused by different aetiologies. However, these diseases are of utmost importance considering that acute presentation is common and the treatment in urgent setting is challenging and still facing high mortality rates. There are still several grey areas regarding the treatment of these pathologies. The last decades showed an increasing utilization of an endovascular approach to treat visceral vessel diseases. On one hand, the early- and mid-term superiority of endovascular revascularization vs. open surgical repair has been demonstrated considering the reduction of morbidity and mortality, and length of stay. However, publications reporting long-term (> five years) are still lacking.
This study is a real-word, ambispective, multi-arm, multicenter study that aims to evaluate the long-term results of visceral vessel revascularization in different diseases, districts, and approaches. Patients will be divided according to the target vessel and index disease. For each subgroup, a comparison between endovascular and open repair will be performed.
Read more
The primary outcome is to compare endovascular and open approach in terms of survival, further divided into overall and disease-related mortality, during long term follow-up (> 5 years). Moreover, early and mid-term data should be considered to provide reliable results. This outcome will be stratified as well within each disease- specific arm.
At the study launch, data collection of patients who have undergone visceral vessels revascularization in the previous 20 years will begin. At the same time, all new cases of visceral vessel revascularization will be proposed for enrollment and follow-up in the prospective arm. The retrospective cohort will provide informative results regarding the long-term survival of these patients. This information will be used to adjust the sample size for the prospective cohort.
Read the detailed description
The 'European Multicentre Study of Long-term Results Following Visceral Arteries Revascularization: the E-VisAR study' is a real-word, ambispective, multi-arm, multicenter study that aims to evaluate the long-term results of visceral vessel revascularization in different diseases, districts, and approaches. Patients will be divided according to the target vessel and index disease. For each subgroup, a comparison between endovascular and open repair will be performed.
Given the study design and the current state of knowledge, here are some potential expected results:
Long-Term Survival Comparison:
The primary expectation is to provide robust, long-term data comparing endovascular and open surgical repair in visceral artery revascularization.
It's possible that the study will confirm the early and mid-term benefits of endovascular procedures in terms of reduced morbidity and mortality, extending these findings to long-term outcomes. However, it's also possible that certain subgroups (e.g., specific diseases, specific vessel involvement) may show different long-term results, with open repair potentially demonstrating superiority in some cases. Endovascular approach may demonstrate higher rate of re-intervention, or lower long term patency for certain diseases.
Disease-Specific Outcomes:
The study will likely reveal variations in outcomes based on the specific disease (e.g., chronic mesenteric ischemia vs. aneurysms). For example, aneurysms might show different long-term patency rates compared to stenotic lesions.
Identification of Risk Factors:
The large dataset will allow for the identification of risk factors associated with adverse long-term outcomes, such as specific comorbidities, anatomical variations, or procedural factors.
Refinement of Treatment Guidelines:
The long-term data will contribute to refining treatment guidelines for visceral artery pathologies, helping to optimize patient selection and procedural techniques.
Real World data:
This study will provide real world data, which is very important to validate the results of randomized control trials, which are often conducted on selected populations. In addition, randomized control trials have not been performed in this field and will likely never happen looking at the diseases limitations.
Relevance for Patients:
Improved Treatment Decisions:
Patients will benefit from more informed treatment decisions, as the study will provide clearer evidence on the long-term effectiveness of different revascularization approaches. This will lead to more personalized treatment plans, tailored to individual patient needs and risk factors.
Reduced Morbidity and Mortality:
By identifying optimal treatment strategies, the study has the potential to reduce morbidity and mortality associated with visceral artery pathologies.
Improved Quality of Life:
Successful revascularization can alleviate symptoms, improve nutritional status, and enhance the overall quality of life for patients with these conditions.
Better understanding of rare diseases:
These diseases are rare, and this study will provide more information to patients that suffer from them.
Relevance for Physicians:
Evidence-Based Practice:
The study will provide valuable evidence to support clinical decision-making, moving away from anecdotal experience and towards evidence-based practice.
Refined Treatment Strategies:
Physicians will gain a better understanding of the long-term outcomes of different revascularization techniques, allowing for more precise and effective treatment strategies.
Identification of High-Risk Patients:
The study will help identify patients at high risk for adverse outcomes, enabling physicians to implement preventive measures and closer monitoring.
Improved Patient Selection:
The data will help physicians to select the best treatment approach for each individual patient.
Contribution to the Field:
The study will contribute to the advancement of knowledge in the field of visceral artery pathologies, ultimately leading to better patient care.
Due to the multicenter nature of the study, this will help to standardize the care of these rare pathologies. In essence, the study is crucial for filling the knowledge gap regarding the long-term outcomes of visceral artery revascularization.
- Conditions
- Visceral Artery Aneurysm, Mesenteric Artery Ischemia, Renal Artery Aneurysm, Renal Artery Stenosis, Renal Artery Stenosis Atherosclerotic, Renal Artery Fibromuscular Dysplasia
- Medical subject headings
- Renal Artery Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective patients | Patients who have undergone visceral vessels revascularization of any kind up to 20 years prior to the study launch. | |
| Prospective patients | Patients enrolled in the study for a visceral vessel revascularization of any kind after the study launch. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
The primary outcome is to compare endovascular and open approach in terms of survival, further divided into overall and disease-related mortality. The outcome will be evaluated at early, mid-, and long-term follow-up, one, three, and five years respectively. This outcome will be stratified as well within each disease- specific arm.
Measured: one, three, and five years
Secondary outcomes (4)
Technical success
defined as successful revascularization meaning correct device positioning with <30% residual stenosis in case of stenotic/occlusive disease, correct sealing without endoleak in case of aneurysm exclusion, or the abscence of reperfusion for coils embolization of aneurysmal disease. The success is given without technical issue hindering device positioning and with no complication occurring during the intervention.
Measured: one, three, and five years
Clinical success
To compare endovascular and open approach in term of early, mid-, and long-term clinical success, meaning the absence of specific symptoms recurrence and revascularized vessel patency or successful aneurysm exclusion without endoleaks or reperfusion and aneurysm growth following embolization.
Measured: one, three, and five years
Long-term patency
To compare endovascular and open approaches in terms of early, mid-, and long-term patency, divided into primary, secondary, and assisted patency. Primary patency will be given if the revascularized artery will be patent at the time point. Secondary patency will be given for the patent artery following a reintervention performed for occlusion. Assisted patency will be given for those arteries requiring additional, non-planned, intervention aimed at maintaining patency, e.g. in case of severe stenosis.
Measured: one, three, and five years
Reintervention rates
To compare endovascular and open approach in term of long term reintervention rates, divided those performed for endoleak, aneurysm growth, restenosis, and occlusion based on index treatment.
Measured: one, three, and five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Visceral Artery 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
- Other
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Modena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Leone, Azienda Ospedaliero-Universitaria di Modena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913530
- Sponsor's protocol ID
- E-VisAR
- Acronym
- E-VisAR
- Status last verified
- Mar 2025
- First submitted
- 13 Feb 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Leone N, D'Oria M, Antoniou G, Koelemay MJ, De Bruin JL, Ronchey S, Baresi GF, van Noord D, Gombert A, Gennai S; EVisAR Study Survey Participantsdagger; EVisAR Study Survey Participants. International Cross Sectional Survey on the Management of Mesenteric Arterial Ischaemia and Renal Artery Stenosis from the European Visceral Artery Revascularisation Study Participants. EJVES Vasc Forum. 2026 Jul 10;66:49-57. doi: 10.1016/j.ejvsvf.2026.07.001. eCollection 2026.
PubMed 42668674
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Multicentre Study of Long-term Results Following Visceral Arteries Revascularization: the E-VisAR Study
- ClinicalTrials.gov ID
- NCT06913530
- Acronym / sponsor ID
- E-VisAR / E-VisAR
- Conditions
- Visceral Artery Aneurysm, Mesenteric Artery Ischemia, Renal Artery Aneurysm, Renal Artery Stenosis, Renal Artery Stenosis Atherosclerotic, Renal Artery Fibromuscular Dysplasia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ModenaUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 6 Apr 2025 (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.
Visceral arteries pathologies are a broad-spectrum of conditions with an extremely low incidence, estimated at 9.2% and 6.2% per 100,000 inhabitants for chronic and acute mesenteric ischemia, respectively, and 0.01-0.2% for aneurysms. The literature regarding the topic is limited in number and fragmented, having multiple vessels involved along with rare conditions caused by different aetiologies. However, these diseases are of utmost importance considering that acute presentation is common and the treatment in urgent setting is challenging and still facing high mortality rates. There are still several grey areas regarding the treatment of these pathologies. The last decades showed an increasing utilization of an endovascular approach to treat visceral vessel diseases. On one hand, the early- and mid-term superiority of endovascular revascularization vs. open surgical repair has been demonstrated considering the reduction of morbidity and mortality, and length of stay. However, publications reporting long-term (> five years) are still lacking.
This study is a real-word, ambispective, multi-arm, multicenter study that aims to evaluate the long-term results of visceral vessel revascularization in different diseases, districts, and approaches. Patients will be divided according to the target vessel and index disease. For each subgroup, a comparison between endovascular and open repair will be performed.
The primary outcome is to compare endovascular and open approach in terms of survival, further divided into overall and disease-related mortality, during long term follow-up (> 5 years). Moreover, early and mid-term data should be considered to provide reliable results. This outcome will be stratified as well within each disease- specific arm.
At the study launch, data collection of patients who have undergone visceral vessels revascularization in the previous 20 years will begin. At the same time, all new cases of visceral vessel revascularization will be proposed for enrollment and follow-up in the prospective arm. The retrospective cohort will provide informative results regarding the long-term survival of these patients. This information will be used to adjust the sample size for the prospective cohort.
Detailed description
The 'European Multicentre Study of Long-term Results Following Visceral Arteries Revascularization: the E-VisAR study' is a real-word, ambispective, multi-arm, multicenter study that aims to evaluate the long-term results of visceral vessel revascularization in different diseases, districts, and approaches. Patients will be divided according to the target vessel and index disease. For each subgroup, a comparison between endovascular and open repair will be performed.
Given the study design and the current state of knowledge, here are some potential expected results:
Long-Term Survival Comparison:
The primary expectation is to provide robust, long-term data comparing endovascular and open surgical repair in visceral artery revascularization.
It's possible that the study will confirm the early and mid-term benefits of endovascular procedures in terms of reduced morbidity and mortality, extending these findings to long-term outcomes. However, it's also possible that certain subgroups (e.g., specific diseases, specific vessel involvement) may show different long-term results, with open repair potentially demonstrating superiority in some cases. Endovascular approach may demonstrate higher rate of re-intervention, or lower long term patency for certain diseases.
Disease-Specific Outcomes:
The study will likely reveal variations in outcomes based on the specific disease (e.g., chronic mesenteric ischemia vs. aneurysms). For example, aneurysms might show different long-term patency rates compared to stenotic lesions.
Identification of Risk Factors:
The large dataset will allow for the identification of risk factors associated with adverse long-term outcomes, such as specific comorbidities, anatomical variations, or procedural factors.
Refinement of Treatment Guidelines:
The long-term data will contribute to refining treatment guidelines for visceral artery pathologies, helping to optimize patient selection and procedural techniques.
Real World data:
This study will provide real world data, which is very important to validate the results of randomized control trials, which are often conducted on selected populations. In addition, randomized control trials have not been performed in this field and will likely never happen looking at the diseases limitations.
Relevance for Patients:
Improved Treatment Decisions:
Patients will benefit from more informed treatment decisions, as the study will provide clearer evidence on the long-term effectiveness of different revascularization approaches. This will lead to more personalized treatment plans, tailored to individual patient needs and risk factors.
Reduced Morbidity and Mortality:
By identifying optimal treatment strategies, the study has the potential to reduce morbidity and mortality associated with visceral artery pathologies.
Improved Quality of Life:
Successful revascularization can alleviate symptoms, improve nutritional status, and enhance the overall quality of life for patients with these conditions.
Better understanding of rare diseases:
These diseases are rare, and this study will provide more information to patients that suffer from them.
Relevance for Physicians:
Evidence-Based Practice:
The study will provide valuable evidence to support clinical decision-making, moving away from anecdotal experience and towards evidence-based practice.
Refined Treatment Strategies:
Physicians will gain a better understanding of the long-term outcomes of different revascularization techniques, allowing for more precise and effective treatment strategies.
Identification of High-Risk Patients:
The study will help identify patients at high risk for adverse outcomes, enabling physicians to implement preventive measures and closer monitoring.
Improved Patient Selection:
The data will help physicians to select the best treatment approach for each individual patient.
Contribution to the Field:
The study will contribute to the advancement of knowledge in the field of visceral artery pathologies, ultimately leading to better patient care.
Due to the multicenter nature of the study, this will help to standardize the care of these rare pathologies. In essence, the study is crucial for filling the knowledge gap regarding the long-term outcomes of visceral artery revascularization.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective patients | – | –Patients who have undergone visceral vessels revascularization of any kind up to 20 years prior to the study launch. |
| Prospective patients | – | –Patients enrolled in the study for a visceral vessel revascularization of any kind after the study launch. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Starting from the study launch, all patients with indication for visceral vessel revascularization will be referred to the study staff for enrollment in the prospective cohort. Assessment of the patient will be performed by a vascular surgeon being part of the Medical Staff. After revascularization, clinical and imaging outcomes will be evaluated at short- (within one year), mid- (three-five years), and long-term (> five years) follow-up. For the retrospective cohort, patients' enrollment eligibility (inclusion/exclusion criteria are listed below) and anamnestic, clinical, and morphological data will be reviewed and collected. Data collection for the retrospective cohort will include all eligible patients who have undergone visceral vessels revascularization up to 20 years from the study launch and regardless of the follow-up time. The two cohorts will be independently followed during the study period.
Key inclusion criteria (4 listed)
- Patients presenting with atherosclerotic disease, aneurysms, or dissection;
- Pathologies involving one or more visceral vessels (celiac, mesenteric, renal arteries, and their branches);
- Patients receiving revascularization, both surgical and endovascular, in elective and urgent/emergent settings;
- For the retrospective cohort, patients who underwent revascularization up to 20 years from the study launch regardless of the follow-up time.
Key exclusion criteria (2 listed)
- Absence of follow-up imaging available and/or reported in follow-up medical reports;
- For the retrospective cohort, a follow-up shorter than three years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: one, three, and five years
The primary outcome is to compare endovascular and open approach in terms of survival, further divided into overall and disease-related mortality. The outcome will be evaluated at early, mid-, and long-term follow-up, one, three, and five years respectively. This outcome will be stratified as well within each disease- specific arm.
4 secondary outcomes
Technical success
Time frame: one, three, and five years
Clinical success
Time frame: one, three, and five years
Long-term patency
Time frame: one, three, and five years
Reintervention rates
Time frame: one, three, and five years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Derived from this study: PubMed 42668674Leone N, D'Oria M, Antoniou G, Koelemay MJ, De Bruin JL, Ronchey S, Baresi GF, van Noord D, Gombert A, Gennai S; EVisAR Study Survey Participantsdagger; EVisAR Study Survey Participants. International Cross Sectional Survey on the Management of Mesenteric Arterial Ischaemia and Renal Artery Stenosis from the European Visceral Artery Revascularisation Study Participants. EJVES Vasc Forum. 2026 Jul 10;66:49-57. doi: 10.1016/j.ejvsvf.2026.07.001. eCollection 2026.
Related trials for Visceral Artery Aneurysm
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Active, not recruitingObservational study
Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Global Registry
Peripheral Artery Disease, Popliteal Aneurysm
Not yet recruitingObservational study
HISTOACRYL® Used for Embolization of Thoracoabdominal Artery Bleeding
Hemorrhage, Gastrointestinal Hemorrhage
RecruitingObservational study
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Post-Market Clinical Follow-Up (PMCF) Observational Registry (RE-PROVE)
Aorto-iliac Occlusive Disease (AIOD), Visceral Artery Occlusive Disease (VAOD)
Not yet recruiting
EUS-guided Embolization of the Visceral Artery Aneurysm
Aneurysm
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Visceral Artery Aneurysm and Mesenteric Artery Ischemia, run by Azienda Ospedaliero-Universitaria di Modena.
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 4 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: opening soon, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicola Leone, MD (+39 0593961225, evisarstudy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: one, three, and five years). 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 NCT06913530, which also lists 1 linked publication.
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 6 Apr 2025.