Clinical trial NCT03475563: BiOSS Study (BiOSS LIM C Stent Registry in Bifurcated Lesions)
Official title: BiOSS LIM C Stent Registry in Bifurcated Lesions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Keywords: Drug-eluting stent
Dedicated bifurcation stent
Cobalt-chromium
Sirolimus-eluting stent
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2018-03-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ischemic heart disease referred for coronary revascularization will be included with susceptible lesion of coronary intervention in bifurcation.

Brief summary: The BIOSS Lim C pharmacoactive Stent has characteristics of design that makes it very suitable for the treatment of bifurcational lesions . The objective of the study is providing deeper knowledge into the results of this stent in the treatment of bifurcational lesions.

Detailed description: The BIOSS Lim C pharmacoactive Stent has characteristics of design that makes it very suitable for the treatment of bifurcational lesions . The objective of the study is providing deeper knowledge into the results of this stent in the treatment of bifurcational lesions.

Eligibility criteria: Inclusion Criteria:

* Age over 18 years.
* 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:

* Express rejection of the patient to participate in the study.
* 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.

Primary outcomes:
measure: Successful angioplasty
timeFrame: 1 day
measure: MACE
timeFrame: 30 days
measure: MACE
timeFrame: 1 year
Secondary outcomes:
measure: Target vessel revascularization
timeFrame: 30 days
measure: Percentage of stent struts malposition
timeFrame: 30 days
measure: contrast media volume
timeFrame: 1 day
measure: Angioplasty time
timeFrame: 1 day
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Hospital Universitari Parc Taulí
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: León
country: Spain
facility: Hospital Universitario de León
Study officials:
affiliation: Hospital Universitari Vall d'hebron Barcelona, Spain
name: Imanol Otaegui, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.