Coroflex® ISAR NEO PMCF Study y ( rEPIC07 )
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Coronary Artery Disease (CAD) and high risk of bleeding
|
Device: Coroflex® ISAR NEO coronary stent system
Patients in whom treatment with Coroflex® ISAR NEO coronary stent system has been attempted
|
| Coronary Artery Disease (CAD)
|
Device: Coroflex® ISAR NEO coronary stent system
Patients in whom treatment with Coroflex® ISAR NEO coronary stent system has been attempted
|
Outcome Measures
Primary Outcome Measures
- Safety Endpoint. Freedom from Target Lesion Failure [7 days]
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)
- Efficacy Endpoint. Freedom fromTarget Lesion Failure [7 days]
Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, and new Target Lesion Revascularization (TLR).
Secondary Outcome Measures
- Freedom from Accidental dislodgement of the stent [During percutaneous coronary intervention (PCI)]
Freedom from Accidental dislodgement of the stent
- Freedom from Balloon rupture [During PCI]
Freedom from Balloon rupture
- Freedom from Hypotube rupture [During PCI]
Freedom from Hypotube rupture
- Freedom from Complicated withdrawal [During PCI]
Freedom from Complicated withdrawal
- Freedom from Coronary perforation [During PCI]
Freedom from Coronary perforation
- Freedom from Coronary dissection >C [During PCI]
Freedom from Coronary dissection >C
- Freedom from No reflow [During PCI]
Freedom from No reflow
- Freedom from Coronary thrombosis [During PCI]
Freedom from Coronary thrombosis
Eligibility Criteria
Criteria
Inclusion Criteria:
Coroflex® ISAR NEO is intended to be used for
-
Patients must be at least 18 years of age AND
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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:
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Patients with express refusal by the patient to participate in the study.
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Patients pregnant women and lactating women.
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Patients with acute coronary syndrome (ACS) in a situation of cardiogenic shock (Killip 4).
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Patients with contraindications or hypersensitivity to sirolimus.
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Patients with a life expectancy of less than 2 years.
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Patients included in other clinical trials.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Fundación EPIC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- Coroflex® ISAR NEO PMCF Study