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

NCT ID: NCT03475563

Last Updated: 2019-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-16

Study Completion Date

2019-12-30

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with coronary artery disease

(coronary artery disease)

Coronary angioplasty with stent implantation

Intervention Type PROCEDURE

Coronary angioplasty with BiOSS LIM C stent implantation

Interventions

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Coronary angioplasty with stent implantation

Coronary angioplasty with BiOSS LIM C stent implantation

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Imanol Otaegui, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitari Vall d'hebron Barcelona, Spain

Locations

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Hospital Universitari Parc Taulí

Sabadell, Barcelona, Spain

Site Status RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitario de León

León, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Imanol Otaegui, MD

Role: CONTACT

+342746155

Imanol Otaegui

Role: CONTACT

Facility Contacts

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Eduard Bosch, MD

Role: primary

Imanol Otaegui, MD

Role: primary

Armando Pérez de Prado, MD, PhD

Role: primary

References

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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.

Reference Type RESULT
PMID: 25828372 (View on PubMed)

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.

Reference Type RESULT
PMID: 25689548 (View on PubMed)

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.

Reference Type RESULT
PMID: 26465375 (View on PubMed)

Other Identifiers

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BIOSS

Identifier Type: -

Identifier Source: org_study_id

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