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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05698732
Other study ID # Coroflex® ISAR NEO PMCF Study
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 4, 2023
Est. completion date February 1, 2027

Study information

Verified date May 2024
Source Fundación EPIC
Contact koldobika García San Román, MD, PhD
Phone 0034696704643
Email koldobikags@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

International, Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Coroflex® ISAR NEO coronary stent system to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Coroflex® ISAR NEO coronary stent system sirolimus eluting stent.


Description:

The objective of this international, multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the Coroflex® ISAR NEO coronary stent system 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 3000
Est. completion date February 1, 2027
Est. primary completion date February 1, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Coroflex® ISAR NEO is intended to be used for - Patients must be at least 18 years of age AND - The patient must fulfill the standard recommendations for Percutaneous Coronary Intervention (PCI) based on the last European Society of Cardiology (ESC) recommendations within his/ her regular treatment or that the use of the product has already been decided within the regular planning of the patient's treatment AND - Patients with Novo lesion length 2-4 mm AND - Informed consent signed Exclusion Criteria: - Patients with express refusal by the patient to participate in the study. - Patients pregnant women and lactating women. - Patients with acute coronary syndrome (ACS) in a situation of cardiogenic shock (Killip 4). - Patients with contraindications or hypersensitivity to sirolimus. - Patients with a life expectancy of less than 2 years. - Patients included in other clinical trials.

Study Design


Intervention

Device:
Coroflex® ISAR NEO coronary stent system
Patients in whom treatment with Coroflex® ISAR NEO coronary stent system has been attempted

Locations

Country Name City State
Spain Hospital Universitario de Badajoz Badajoz
Spain Hospital Universitari Germans Trias I Pujol Badalona
Spain Hospital Universitario de Cruces Barakaldo
Spain Hospital Universitari Vall D Hebron Barcelona
Spain Hospital Universitario San Pedro de Alcantara Cáceres
Spain Hospital General Universitario de Ciudad Real Ciudad Real
Spain Hospital Universitario A Coruña Coruña
Spain Hospital Universitario Juan Ramon Jimenez Huelva
Spain Hospital Universitario de Leon León
Spain Hospital Universitario Lucus Agusti Lugo
Spain Hospital Clinico Universitario Lozano Blesa Zaragoza

Sponsors (1)

Lead Sponsor Collaborator
Fundación EPIC

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Knuuti J, Wijns W, Saraste A, Capodanno D, Barbato E, Funck-Brentano C, Prescott E, Storey RF, Deaton C, Cuisset T, Agewall S, Dickstein K, Edvardsen T, Escaned J, Gersh BJ, Svitil P, Gilard M, Hasdai D, Hatala R, Mahfoud F, Masip J, Muneretto C, Valgimigli M, Achenbach S, Bax JJ; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes. Eur Heart J. 2020 Jan 14;41(3):407-477. doi: 10.1093/eurheartj/ehz425. No abstract available. Erratum In: Eur Heart J. 2020 Nov 21;41(44):4242. — View Citation

Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available. Erratum In: Eur Heart J. 2019 Oct 1;40(37):3096. — View Citation

Ruiz-Nodar JM, Ferreiro JL. Tratamiento antitrómbotico tras revascularización percutánea en pacientes con indicación crónica de anticoagulación oral. REC Interv Cardiol. 2019;1(1):41-50.

Urban P, Mehran R, Colleran R, Angiolillo DJ, Byrne RA, Capodanno D, Cuisset T, Cutlip D, Eerdmans P, Eikelboom J, Farb A, Gibson CM, Gregson J, Haude M, James SK, Kim HS, Kimura T, Konishi A, Laschinger J, Leon MB, Magee PFA, Mitsutake Y, Mylotte D, Pocock S, Price MJ, Rao SV, Spitzer E, Stockbridge N, Valgimigli M, Varenne O, Windhoevel U, Yeh RW, Krucoff MW, Morice MC. Defining high bleeding risk in patients undergoing percutaneous coronary intervention: a consensus document from the Academic Research Consortium for High Bleeding Risk. Eur Heart J. 2019 Aug 14;40(31):2632-2653. doi: 10.1093/eurheartj/ehz372. — 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, stent thrombosis (Academic Research Consortium definitive/ probable), and new Target Lesion Revascularization (TLR) 7 days
Primary 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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