Essential Pro PMCF Study ( rEPIC04E ) (rEPIC04E)

Essential Pro Post-Market Clinical Follow-up Study

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.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Heart Disease; Coronary Artery Disease (CAD)
• Intervention / Treatment: Drug: Essential pro

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 176

Contacts and Locations

• Study Contact: Name: FUNDACION EPIC; Phone Number: 987225638; Email: iepic@fundacionepic.org
• Study Contact Backup: Name: FUNDACION EPIC; Phone Number: 987225638; Email: admin@fundacionepic.org

Study Locations

• Spain
  • Algeciras, Spain, 11207
    • Recruiting
    • Hospital Punta de Europa
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clinic de Barcelona
  • Jerez De La Frontera, Spain, 11407
    • Recruiting
    • Hospital Universitario de Jerez de la Frontera
  • León, Spain, 24080
    • Recruiting
    • Hospital Universitario de Leon
  • Málaga, Spain, 29010
    • Recruiting
    • Hospital Universitario Regional de Málaga
  • Puerto Real, Spain, 11510
    • Recruiting
    • Hospital Universitario de Puerto Real
  • Santander, Spain, 39008
    • Recruiting
    • Hospital Universitario Marques de Valdecilla

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients treated with Essential Pro according to routine hospital practice and following instructions for use

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Coronary Artery Disease (CAD)	Drug: Essential pro; Patients in whom treatment with (Essential Pro) has been attempted

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from Complicated withdrawal	Freedom from Complicated withdrawal	During PCI
Freedom from Coronary perforation	Freedom from Coronary perforation	During PCI
Freedom from Coronary dissection >C	Freedom from Coronary dissection >C	During PCI
Freedom from No reflow	Freedom from No reflow	During PCI
Freedom from Coronary thrombosis	Freedom from Coronary thrombosis	During PCI
Freedom from Balloon rupture	Freedom from Balloon rupture	During percutaneous coronary intervention (PCI)
Freedom from Hypotube rupture	Freedom from Hypotube rupture	During PCI
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

Collaborators and Investigators

• Sponsor: Fundación EPIC

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2022
• Primary Completion (Estimated): February 2, 2025
• Study Completion (Estimated): March 30, 2025

Study Registration Dates

• First Submitted: March 14, 2022
• First Submitted That Met QC Criteria: March 14, 2022
• First Posted (Actual): March 23, 2022

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: MDR (Medical Device Regulations); PMCF (Post-Market Clinical Follow-up); Paclitaxel eluting coronary balloon dilatation catheter
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia
• Other Study ID Numbers: Essential Pro PMCF Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No