European Multicentre Study of Long-term Results Following Visceral Arteries Revascularization: the E-VisAR Study

NCT06913530 | Not Yet Recruiting

• 1 other identifier: E-VisAR
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  one, three, and five years

Secondary Outcomes (4)

• Technical success

  one, three, and five years

• Clinical success

  one, three, and five years

• Long-term patency

  one, three, and five years

• Reintervention rates

  one, three, and five years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Modena: lead

MeSH Terms

Conditions

Renal Artery Obstruction

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Nicola Leone, MD

CONTACT

+39 0593961225; evisarstudy@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: April 6, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): June 1, 2030
• Last Updated: April 6, 2025

Record last verified: 2025-03