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NCT05292092 Clinical Trial

Essential Pro PMCF Study ( rEPIC04E )

Ischemic Heart Disease Clinical Trial

— rEPIC04E  

Official title:
Essential Pro Post-Market Clinical Follow-up Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05292092
Other study ID # Essential Pro 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 2024
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 Essential Pro to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Essential Pro.

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 Essential Pro 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 176
Est. completion date March 30, 2025
Est. primary completion date February 2, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient treated with Essential Pro according to routine hospital practice and following instructions for use - Informed consent signed Exclusion Criteria: • Not meet inclusion criteria

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Essential pro
Patients in whom treatment with (Essential Pro) has been attempted

Locations
Country Name City State
Spain Hospital Punta de Europa Algeciras
Spain Hospital Clinic de Barcelona Barcelona
Spain Hospital Universitario de Jerez de la Frontera Jerez De La Frontera
Spain Hospital Universitario de Leon León
Spain Hospital Universitario Regional de Malaga Málaga
Spain Hospital Universitario de Puerto Real Puerto Real
Spain Hospital Universitario Marques de Valdecilla Santander

Sponsors (1)
Lead Sponsor Collaborator
Fundación EPIC

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Gruntzig A. Transluminal dilatation of coronary-artery stenosis. Lancet. 1978 Feb 4;1(8058):263. doi: 10.1016/s0140-6736(78)90500-7. No abstract available. — View Citation

Jeger RV, Farah A, Ohlow MA, Mangner N, Mobius-Winkler S, Leibundgut G, Weilenmann D, Wohrle J, Richter S, Schreiber M, Mahfoud F, Linke A, Stephan FP, Mueller C, Rickenbacher P, Coslovsky M, Gilgen N, Osswald S, Kaiser C, Scheller B; BASKET-SMALL 2 Investigators. Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial. Lancet. 2018 Sep 8;392(10150):849-856. doi: 10.1016/S0140-6736(18)31719-7. Epub 2018 Aug 28. — View Citation

Wu X, Li L, He L. Drug-Coated Balloon versus Drug-Eluting Stent in Patients with Small-Vessel Coronary Artery Disease: A Meta-Analysis of Randomized Controlled Trials. Cardiol Res Pract. 2021 Apr 13;2021:1647635. doi: 10.1155/2021/1647635. eCollection 2021. — View Citation

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 (MI) and a new Target Lesion Revascularization (TLR). 12 months
Secondary Efficacy Endpoint. Freedom from Target Lesion Failure (TLF) Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, and new Target Lesion Revascularization (TLR). 12 months
Secondary Freedom from Balloon rupture Freedom from Balloon rupture During percutaneous coronary intervention (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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