Clinical trial NCT06913530: European Multicentre Study of Long-term Results Following Visceral Arteries Revascularization: the E-VisAR Study
Official title: European Multicentre Study of Long-term Results Following Visceral Arteries Revascularization: the E-VisAR Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Visceral Artery Aneurysm
Mesenteric Artery Ischemia
Renal Artery Aneurysm
Renal Artery Stenosis
Renal Artery Stenosis Atherosclerotic
Renal Artery Fibromuscular Dysplasia
Chronic Mesenteric Ischemia
Visceral Artery Dissection
Mesenteric Artery Dissection
Lead sponsor: Azienda Ospedaliero-Universitaria di Modena
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Overall survival
timeFrame: one, three, and five years
Secondary outcomes:
measure: Technical success
timeFrame: one, three, and five years
measure: Clinical success
timeFrame: one, three, and five years
measure: Long-term patency
timeFrame: one, three, and five years
measure: Reintervention rates
timeFrame: one, three, and five years
Other outcomes:
Locations:
Study officials:
References: