Coroflex® ISAR NEO PMCF Study

Official title

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

Overview

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.

Detailed 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.

Interventions

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

Primary outcome measures

• Safety Endpoint. Freedom from Target Lesion Failure [Time frame: 7 days]
• Efficacy Endpoint. Freedom fromTarget Lesion Failure [Time frame: 7 days]

Secondary outcome measures (8)

• Freedom from Accidental dislodgement of the stent [Time frame: During percutaneous coronary intervention (PCI)]
• Freedom from Balloon rupture [Time frame: During PCI]
• Freedom from Hypotube rupture [Time frame: During PCI]
• Freedom from Complicated withdrawal [Time frame: During PCI]
• Freedom from Coronary perforation [Time frame: During PCI]
• Freedom from Coronary dissection >C [Time frame: During PCI]
• Freedom from No reflow [Time frame: During PCI]
• Freedom from Coronary thrombosis [Time frame: During PCI]

Eligibility criteria

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 in whom anti-platelet and/or anti-coagulation therapy is contraindicated
• Patients with lesions, that possibly can not be treated successfully with Percutaneous transluminal Coronary Angioplasty (PTCA) or stent implantation
• Patients with known sensitivity to Sirolimus, the carrier Probucol, the procedural co-medication or the alloying component of the stent
• Patients with known sensitivity to contrast agents who cannot be premedicated.
• Patients with contraindications or hypersensitivity to sirolimus
• Patients with a life expectancy of less than 2 years
• Patients included in other clinical trials

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Spain · 14 centers

• Hospital Universitario A Coruña — A Coruña
• Hospital Universitario de Badajoz — Badajoz
• Hospital Universitari Germans Trias I Pujol — Badalona
• Hospital Universitario de Cruces — Barakaldo
• Hospital de la Santa Creu i Sant Pau — Barcelona
• Hospital Universitari Vall D Hebron — Barcelona
• Hospital Universitario San Pedro de Alcantara — Cáceres
• Hospital General Universitario de Ciudad Real — Ciudad Real
• … and 6 more centers

France · 8 centers

• Centre Hospitalier du Pays d'Aix — Aix-en-Provence
• Centre Hospitalier Ajaccio — Ajaccio
• CH Polyclinique Bordeaux Nord Aquitaine — Bordeaux
• University Hospital Center of Caen — Caen
• Hôpital Albert Schweitzer — Colmar
• Hospitalario Universitario (CHU) de Lille — Lille
• APHP -Hôpital Lariboisière — Paris
• Institut Arnault Tzanck — Saint-Laurent-du-Var

Publications

• 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 ri PMID 31116395
• 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/eurhear PMID 30165437
• 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 PMID 31504439
• 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.

Identifiers

NCT: NCT05698732 · Coroflex® ISAR NEO PMCF Study

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗