BiOSS Study (BiOSS LIM C Stent Registry in Bifurcated Lesions)

Coronary Artery Disease Clinical Trial

— BIOSS  

Official title:

BiOSS LIM C Stent Registry in Bifurcated Lesions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03475563
• Other study ID #: BIOSS
• Status: Recruiting
• Start date: August 16, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: November 2019
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: Imanol Otaegui, MD
• Phone: +342746155
• Email: iotaegui[@]vhebron.net
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Procedure:
• Coronary angioplasty with stent implantation
Coronary angioplasty with BiOSS LIM C stent implantation

Locations

Country	Name	City	State
Spain	Hospital Universitari Vall d`Hebron	Barcelona
Spain	Hospital Universitario de León	León
Spain	Hospital Universitari Parc Taulí	Sabadell	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Gil RJ, Bil J, Džavík 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 — View Citation

Gil RJ, Bil J, Grundeken MJ, Iñigo Garcia LA, Vassilev D, Kern A, Pawlowski T, Wykrzykowska JJ, Serruys PW. Long-term effectiveness and safety of the sirolimus-eluting BiOSS LIM® dedicated bifurcation stent in the treatment of distal left main stenosis: a — View Citation

Gil RJ, Bil J, Vassiliev D, Iñigo Garcia LA. First-in-man study of dedicated bifurcation sirolimus-eluting stent: 12-month results of BiOSS LIM® Registry. J Interv Cardiol. 2015 Feb;28(1):51-60. doi: 10.1111/joic.12180. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful angioplasty	After angiography: TIMI (thrombolysis in myocardial infarction ) 3 (both branches). With respect to reference diameter, none of the segments treated with stent has a residual stenosis> 30% or> 50% in those not treated with stent.	1 day
Primary	MACE	Cumulative rate of major adverse cardiovascular events (MACE) including cardiac death, myocardial infarction (MI) and repeated revascularization of the target lesion (TLR)	30 days
Primary	MACE	Cumulative rate of major adverse cardiovascular events (MACE) including cardiac	1 year
Secondary	Target vessel revascularization	Target vessel revascularization	30 days
Secondary	Percentage of stent struts malposition	Percentage of stent struts malposition	30 days
Secondary	contrast media volume	contrast media volume	1 day
Secondary	Angioplasty time	Angioplasty time	1 day