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

BiOSS LIM C Stent Registry in Bifurcated Lesions

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03475563

Acronym

BIOSS

Enrollment

100

Registered

2018-03-23

Start date

2018-08-16

Completion date

2019-12-30

Last updated

2019-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Drug-eluting stent, Dedicated bifurcation stent, Cobalt-chromium, Sirolimus-eluting stent

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

Interventions

PROCEDURECoronary angioplasty with stent implantation

Coronary angioplasty with BiOSS LIM C stent implantation

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.
MACE	30 days	Cumulative rate of major adverse cardiovascular events (MACE) including cardiac death, myocardial infarction (MI) and repeated revascularization of the target lesion (TLR)

Secondary

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

Countries

Spain

Contacts

Primary ContactImanol Otaegui, MD

iotaegui@vhebron.net+342746155

Backup ContactImanol Otaegui

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026