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NCT Number: NCT05292014

ANGIOLITE PMCF Study ( rEPIC04F )

Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Angiolite sirolimus eluting stent to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Angiolite sirolimus eluting stent.

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Key information

Conditions

Coronary Artery Disease (CAD) Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Ischemic Heart Disease Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Clinic de Barcelona, Barcelona, Spain

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Angiolite

Device

Patients in whom treatment with ANGIOLITE has been attempted

Primary outcomes

  1. Safety Endpoint. Freedom from Target Lesion Failure

    Time frame: 7 days

    Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, stent thrombosis (Academic Research Consortium definitive/ probable), and new Target Lesion Revascularization (TLR)

Secondary outcomes

  1. Efficacy Endpoint. Freedom fromTarget Lesion Failure

    Time frame: 7 days

    Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, and new Target Lesion Revascularization (TLR).

  2. Freedom from Accidental dislodgement of the stent

    Time frame: During percutaneous coronary intervention (PCI)

    Freedom from Accidental dislodgement of the stent

  3. Freedom from Balloon rupture

    Time frame: During PCI

    Freedom from Balloon rupture

  4. Freedom from Hypotube rupture

    Time frame: During PCI

    Freedom from Hypotube rupture

  5. Freedom from Complicated withdrawal

    Time frame: During PCI

    Freedom from Complicated withdrawal

  6. Freedom from Coronary perforation

    Time frame: During PCI

    Freedom from Coronary perforation

  7. Freedom from Coronary dissection >C

    Time frame: During PCI

    Freedom from Coronary dissection >C

  8. Freedom from No reflow

    Time frame: During PCI

    Freedom from No reflow

  9. Freedom from Coronary thrombosis

    Time frame: During PCI

    Freedom from Coronary thrombosis

Sponsors and collaborators

Lead sponsor

Fundación EPIC

Other

Registry information

Official study title

ANGIOLITE Post-Market Clinical Follow-up Study

Acronym: rEPIC04F

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 23, 2022
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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