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

V

Vall d'Hebron University Hospital (HUVH)

Status

Unknown

Conditions

Coronary Artery Disease

Treatments

Procedure: Coronary angioplasty with stent implantation

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

100 participants in 1 patient group

Patients with coronary artery disease
Description:
(coronary artery disease)
Treatment:
Procedure: Coronary angioplasty with stent implantation

Trial contacts and locations

3

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Central trial contact

Imanol Otaegui, MD; Imanol Otaegui

Data sourced from clinicaltrials.gov

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