Coroflex® ISAR NEO PMCF Study

Ischemic Heart Disease Clinical Trial

— rEPIC07  

Official title:

Coroflex® ISAR NEO Coronary Stent System Post-Market Clinical Follow-up Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05698732
• Other study ID #: Coroflex® ISAR NEO PMCF Study
• Status: Recruiting
• Start date: August 4, 2023
• Est. completion date: February 1, 2027

Study information

• Verified date: February 2024
• Source: Fundación EPIC
• Contact: koldobika García San Román, MD, PhD
• Phone: 0034696704643
• Email: koldobikags[@]hotmail.com
• Is FDA regulated: No
• 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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Disease (CAD)
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

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 Universitario San Pedro de Alcantara	Cáceres
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