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

ConditionsVisceral Artery AneurysmMesenteric Artery IschemiaRenal Artery AneurysmRenal Artery StenosisRenal Artery Stenosis AtheroscleroticRenal Artery Fibromuscular DysplasiaChronic Mesenteric IschemiaVisceral Artery DissectionMesenteric Artery Dissection
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

This trial does not accept healthy volunteers

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 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.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

500 Participants
are grouped into 2 trial groups
Group A: Retrospective patients
Group B: Prospective patients

Trial outcomes

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.

Time frame
one, three, and five years

Secondary outcomes

1

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.

Time frame
one, three, and five years
2

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.

Time frame
one, three, and five years
3

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.

Time frame
one, three, and five years
4

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.

Time frame
one, three, and five years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Azienda Ospedaliero-Universitaria di Modena

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: