Completed

rEPIC04FANGIOLITE Post-Market Clinical Follow-up Study

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Arterial Occlusive Diseases+5

+ Arteriosclerosis

+ Cardiovascular Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: September 2022
See protocol details

Summary

Principal SponsorFundación EPIC
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 26, 2022

Actual date on which the first participant was enrolled.

The objective of this multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the Angiolite Sirolimus Eluting Stent in a NON-SELECTED, Real World population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device regulation requirements for post-market clinical follow-up.

Official TitleANGIOLITE Post-Market Clinical Follow-up Study
NCT05292014
Principal SponsorFundación EPIC
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

81 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arterial Occlusive DiseasesArteriosclerosisCardiovascular DiseasesCoronary Artery DiseaseCoronary DiseaseHeart DiseasesVascular DiseasesMyocardial Ischemia

Criteria

Inclusion Criteria: * Patients treated with ANGIOLITE according to routine hospital practice and following instructions for use * Informed consent signed Exclusion Criteria: • Not meet inclusion criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 6 locations

Suspended

Hospital Clinic de Barcelona

Barcelona, SpainOpen Hospital Clinic de Barcelona in Google Maps
Suspended

H. Puerta Del Mar

Cadiz, Spain
Suspended

Hospital Universitario de Leon

León, Spain
Suspended

Hospital Universitario Virgen de La Victoria

Málaga, Spain
Completed6 Study Centers