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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05292014
Other study ID # ANGIOLITE PMCF Study
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 26, 2022
Est. completion date March 30, 2025

Study information

Verified date January 2023
Source Fundación EPIC
Contact FUNDACION EPIC
Phone 987225638
Email iepic@fundacionepic.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


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Study Design


Intervention

Device:
ANGIOLITE
Patients in whom treatment with ANGIOLITE has been attempted

Locations

Country Name City State
Spain 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 Hospital Universitario Marques de Valdecilla Santander
Spain Hospital Clinico Universitario de Santiago de Compostela Santiago De Compostela

Sponsors (1)

Lead Sponsor Collaborator
Fundación EPIC

Country where clinical trial is conducted

Spain, 

References & Publications (7)

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Outcome

Type Measure Description Time frame Safety issue
Primary 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) 7 days
Secondary 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). 7 days
Secondary Freedom from Accidental dislodgement of the stent Freedom from Accidental dislodgement of the stent During percutaneous coronary intervention (PCI)
Secondary Freedom from Balloon rupture Freedom from Balloon rupture During PCI
Secondary Freedom from Hypotube rupture Freedom from Hypotube rupture During PCI
Secondary Freedom from Complicated withdrawal Freedom from Complicated withdrawal During PCI
Secondary Freedom from Coronary perforation Freedom from Coronary perforation During PCI
Secondary Freedom from Coronary dissection >C Freedom from Coronary dissection >C During PCI
Secondary Freedom from No reflow Freedom from No reflow During PCI
Secondary Freedom from Coronary thrombosis Freedom from Coronary thrombosis During PCI
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