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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAzienda Ospedaliero-Universitaria di Modena

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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 design

Treatments tested in this trial

  • Not listed

Trial groups

500 Participants
are grouped into 2 trial groups

Locations

This trial has no locations