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

• Conditions: Coronary Artery Disease
• Interventions: Procedure: Coronary angioplasty with stent implantation

• Registration Number: NCT03475563
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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.

Study Timeline

• Study First Submitted: 2018-03-16
• Study First Submitted QC: 2018-03-16
• Study First Posted: 2018-03-23
• Study Start: 2018-08-16
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-26
• Last Update Posted: 2019-11-27
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with coronary artery disease	Coronary angioplasty with stent implantation	(coronary artery disease)

Primary Outcome Measures

Name	Time	Method
MACE	1 year	Cumulative rate of major adverse cardiovascular events (MACE) including cardiac
Successful angioplasty	1 day	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.

Secondary Outcome Measures

Name	Time	Method
Target vessel revascularization	30 days	Target vessel revascularization
contrast media volume	1 day	contrast media volume
Percentage of stent struts malposition	30 days	Percentage of stent struts malposition
Angioplasty time	1 day	Angioplasty time

Trial Locations

Locations (3)

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Universitario de León; 🇪🇸 León, Spain

Hospital Universitari Parc Taulí; 🇪🇸 Sabadell, Barcelona, Spain