BiOSS Study (BiOSS LIM C Stent Registry in Bifurcated Lesions)
NCT ID: NCT03475563
Last Updated: 2019-11-27
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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UNKNOWN
100 participants
OBSERVATIONAL
2018-08-16
2019-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Patients with coronary artery disease
(coronary artery disease)
Coronary angioplasty with stent implantation
Coronary angioplasty with BiOSS LIM C stent implantation
Interventions
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Coronary angioplasty with stent implantation
Coronary angioplasty with BiOSS LIM C stent implantation
Eligibility Criteria
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Inclusion Criteria
* Clinical indication of coronary angioplasty in bifurcated lesion.
* Bifurcated lesions with both distal branches at least 2 mm in diameter.
* The lesion must be located in the main branch, with a severe stenosis by visual estimation at some point in the main branch, with or without involvement of the lateral branch.
* Express acceptance and signature of informed consent.
Exclusion Criteria
* Exclusive involvement of the lateral branch (Medina lesion 001).
* Contraindication for antiplatelet treatment.
* Lesions due to restenosis.
* Lesions in saphenous grafts.
* Total chronic occlusions.
* Cardiogenic shock.
18 Years
ALL
No
Sponsors
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Hospital Universitari Vall d'Hebron Research Institute
OTHER
Responsible Party
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Principal Investigators
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Imanol Otaegui, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitari Vall d'hebron Barcelona, Spain
Locations
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Hospital Universitari Parc Taulí
Sabadell, Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitario de León
León, , Spain
Countries
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Central Contacts
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Imanol Otaegui
Role: CONTACT
Facility Contacts
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Eduard Bosch, MD
Role: primary
Imanol Otaegui, MD
Role: primary
Armando Pérez de Prado, MD, PhD
Role: primary
References
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Gil RJ, Bil J, Dzavik V, Vassilev D, Kern A, Formuszewicz R, Zalewska-Adamiec M, Dobrzycki S. Regular Drug-Eluting Stent vs Dedicated Coronary Bifurcation BiOSS Expert Stent: Multicenter Open-Label Randomized Controlled POLBOS I Trial. Can J Cardiol. 2015 May;31(5):671-8. doi: 10.1016/j.cjca.2014.12.024. Epub 2014 Dec 24.
Gil RJ, Bil J, Vassiliev D, Inigo Garcia LA. First-in-man study of dedicated bifurcation sirolimus-eluting stent: 12-month results of BiOSS LIM(R) Registry. J Interv Cardiol. 2015 Feb;28(1):51-60. doi: 10.1111/joic.12180.
Gil RJ, Bil J, Grundeken MJ, Inigo Garcia LA, Vassilev D, Kern A, Pawlowski T, Wykrzykowska JJ, Serruys PW. Long-term effectiveness and safety of the sirolimus-eluting BiOSS LIM(R) dedicated bifurcation stent in the treatment of distal left main stenosis: an international registry. EuroIntervention. 2016 Nov 20;12(10):1246-1254. doi: 10.4244/EIJY15M10_05.
Other Identifiers
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BIOSS
Identifier Type: -
Identifier Source: org_study_id
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