Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
3000 participants
OBSERVATIONAL
2023-08-04
2027-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Coronary Artery Disease (CAD) and high risk of bleeding
Coroflex® ISAR NEO coronary stent system
Patients in whom treatment with Coroflex® ISAR NEO coronary stent system has been attempted
Coronary Artery Disease (CAD)
Coroflex® ISAR NEO coronary stent system
Patients in whom treatment with Coroflex® ISAR NEO coronary stent system has been attempted
Interventions
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Coroflex® ISAR NEO coronary stent system
Patients in whom treatment with Coroflex® ISAR NEO coronary stent system has been attempted
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Fundación EPIC
OTHER
Responsible Party
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Locations
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Centre Hospitalier du Pays d'Aix
Aix-en-Provence, , France
Centre Hospitalier Ajaccio
Ajaccio, , France
University Hospital Center of Caen
Caen, , France
Hôpital Albert Schweitzer
Colmar, , France
Hospitalario Universitario (CHU) de Lille
Lille, , France
APHP -Hôpital Lariboisière
Paris, , France
Hospital Universitario A Coruña
A Coruña, , Spain
Hospital Universitario de Badajoz
Badajoz, , Spain
Hospital Universitari Germans Trias I Pujol
Badalona, , Spain
Hospital Universitario de Cruces
Barakaldo, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , 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 Juan Ramon Jimenez
Huelva, , Spain
Hospital Universitario de Leon
León, , Spain
Hospital Universitario Lucus Agusti
Lugo, , Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, , Spain
Countries
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Central Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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Coroflex® ISAR NEO PMCF Study
Identifier Type: -
Identifier Source: org_study_id
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