ANGIOLITE PMCF Study ( rEPIC04F )

N/ACompletedNCT05292014

Fundación EPIC81 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Coronary Artery Disease (CAD)Ischemic Heart Disease

Interventions

ANGIOLITEDEVICE

Patients in whom treatment with ANGIOLITE has been attempted

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Hospital Clinic de Barcelona

Barcelona, Spain

H. Puerta Del Mar

Cadiz, Spain

Hospital Universitario de Leon

León, Spain

Hospital Universitario Virgen de La Victoria

Málaga, Spain

Outcomes

Primary Outcomes

Safety Endpoint. Freedom from Target Lesion Failure

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)

Time frame: 7 days

Secondary Outcomes

Efficacy Endpoint. Freedom fromTarget Lesion Failure

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

Time frame: 7 days

Freedom from Accidental dislodgement of the stent

Time frame: During percutaneous coronary intervention (PCI)

Freedom from Balloon rupture

Time frame: During PCI

Freedom from Hypotube rupture

Time frame: During PCI

Freedom from Complicated withdrawal

Time frame: During PCI

Freedom from Coronary perforation

Time frame: During PCI

Freedom from Coronary dissection >C

Freedom from Coronary dissection \>C

Time frame: During PCI

Data from ClinicalTrials.gov

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