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Status unknownNCT03475563BIOSSUpdated Nov 27, 2019

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

An observational study in Coronary Artery Disease, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Status unknown at 3 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-27.

Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Observational

The sponsor has not verified this record recently (last verified Nov 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • Drug-eluting stent
  • Dedicated bifurcation stent
  • Cobalt-chromium
  • Sirolimus-eluting stent
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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.
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
100 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes

Groups and cohorts

  • Patients with coronary artery disease

    (coronary artery disease)

    Procedure: Coronary angioplasty with stent implantation

Interventions

  • ProcedureCoronary angioplasty with stent implantation

    Coronary angioplasty with BiOSS LIM C stent implantation

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 day

  2. MACE

    Cumulative rate of major adverse cardiovascular events (MACE) including cardiac death, myocardial infarction (MI) and repeated revascularization of the target lesion (TLR)

    Time frame: 30 days

  3. MACE

    Cumulative rate of major adverse cardiovascular events (MACE) including cardiac

    Time frame: 1 year

Secondary outcomes

  1. Target vessel revascularization

    Target vessel revascularization

    Time frame: 30 days

  2. Percentage of stent struts malposition

    Percentage of stent struts malposition

    Time frame: 30 days

  3. contrast media volume

    contrast media volume

    Time frame: 1 day

  4. Angioplasty time

    Angioplasty time

    Time frame: 1 day

06

Study locations

3 of 3 sites recruiting
  • Hospital Universitari Parc Taulí
    Sabadell, Barcelona 08208, Spain
    • Eduard Bosch, MD · Contact
    Recruiting
  • Hospital Universitari Vall d'Hebron
    Barcelona, 08035, Spain
    • Imanol Otaegui, MD · Contact
    Recruiting
  • Hospital Universitario de León
    León, 24071, Spain
    • Armando Pérez de Prado, MD, PhD · Contact
    Recruiting
07

References and documents

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. PubMed 25828372 ↗
  • 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. PubMed 25689548 ↗
  • 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. PubMed 26465375 ↗
08

Registry details

Key details

Study ID
NCT03475563
Lead sponsor
Hospital Universitari Vall d'Hebron Research Institute
Responsible party
Sponsor
First posted
Mar 23, 2018
Start date
Aug 16, 2018
Primary completion
Dec 30, 2019 (estimated)
Completion
Dec 30, 2019 (estimated)
Last update
Nov 27, 2019

Study contacts

Imanol Otaegui, MD
Contact
iotaegui@vhebron.net
+342746155
Imanol Otaegui
Contact
Imanol Otaegui, MD
principal investigator · Hospital Universitari Vall d'hebron Barcelona, Spain

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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