Ischemic Heart Disease Clinical Trial
— rEPIC04EOfficial title:
Essential Pro Post-Market Clinical Follow-up Study
Verified date | January 2024 |
Source | Fundación EPIC |
Contact | FUNDACION EPIC |
Phone | 987225638 |
iepic[@]fundacionepic.org | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Fundación EPIC |
Spain,
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
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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