Clinical trial NCT05292092: Essential Pro PMCF Study ( rEPIC04E )
Official title: Essential Pro Post-Market Clinical Follow-up Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease (CAD)
Ischemic Heart Disease
Keywords: MDR (Medical Device Regulations)
PMCF (Post-Market Clinical Follow-up)
Paclitaxel eluting coronary balloon dilatation catheter
Lead sponsor: Fundación EPIC
Sponsor class: OTHER
First posted: 2022-03-23
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with Essential Pro according to routine hospital practice and following instructions for use

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety Endpoint. Freedom from Target Lesion Failure
timeFrame: 12 months
Secondary outcomes:
measure: Efficacy Endpoint. Freedom from Target Lesion Failure (TLF)
timeFrame: 12 months
measure: Freedom from Balloon rupture
timeFrame: During percutaneous coronary intervention (PCI)
measure: Freedom from Hypotube rupture
timeFrame: During PCI
measure: Freedom from Complicated withdrawal
timeFrame: During PCI
measure: Freedom from Coronary perforation
timeFrame: During PCI
measure: Freedom from Coronary dissection >C
timeFrame: During PCI
measure: Freedom from No reflow
timeFrame: During PCI
measure: Freedom from Coronary thrombosis
timeFrame: During PCI
Other outcomes:
Locations:
city: Algeciras
country: Spain
facility: Hospital Punta de Europa
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Jerez De La Frontera
country: Spain
facility: Hospital Universitario de Jerez de la Frontera
city: León
country: Spain
facility: Hospital Universitario de Leon
city: Málaga
country: Spain
facility: Hospital Universitario Regional de Malaga
city: Puerto Real
country: Spain
facility: Hospital Universitario de Puerto Real
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
Study officials:
References:
citation: 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.
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.
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.