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

BiOSS LIM C Stent Registry in Bifurcated Lesions

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Procedure: Coronary angioplasty with stent implantation

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitari Vall d'Hebron
    • Contact: Imanol Otaegui, MD
  • León, Spain, 24071
    • Recruiting
    • Hospital Universitario de Leon
    • Contact: Armando Pérez de Prado, MD, PhD
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Recruiting
      • Hospital Universitari Parc Tauli
      • Contact: Eduard Bosch, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with coronary artery disease; (coronary artery disease)	Procedure: Coronary angioplasty with stent implantation; Coronary angioplasty with BiOSS LIM C stent implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
MACE	Cumulative rate of major adverse cardiovascular events (MACE) including cardiac	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target vessel revascularization	Target vessel revascularization	30 days
Percentage of stent struts malposition	Percentage of stent struts malposition	30 days
contrast media volume	contrast media volume	1 day
Angioplasty time	Angioplasty time	1 day

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Investigators: Principal Investigator: Imanol Otaegui, MD, Hospital Universitari Vall d'hebron Barcelona, Spain

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2018
• Primary Completion (Anticipated): December 30, 2019
• Study Completion (Anticipated): December 30, 2019

Study Registration Dates

• First Submitted: March 16, 2018
• First Submitted That Met QC Criteria: March 16, 2018
• First Posted (Actual): March 23, 2018

Study Record Updates

• Last Update Posted (Actual): November 27, 2019
• Last Update Submitted That Met QC Criteria: November 26, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Drug-eluting stent; Dedicated bifurcation stent; Cobalt-chromium; Sirolimus-eluting stent
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: BIOSS