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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03475563
Recruitment Status : Unknown
Verified November 2019 by Hospital Universitari Vall d'Hebron Research Institute.
Recruitment status was:  Recruiting
First Posted : March 23, 2018
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

Study Description
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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.

Condition or disease Intervention/treatment
Coronary Artery Disease Procedure: Coronary angioplasty with stent implantation

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: BiOSS LIM C Stent Registry in Bifurcated Lesions
Actual Study Start Date : August 16, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients with coronary artery disease
(coronary artery disease)
 Procedure: Coronary angioplasty with stent implantation
Coronary angioplasty with BiOSS LIM C stent implantation


Outcome Measures
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Primary Outcome Measures :
  1. Successful angioplasty [ Time Frame: 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.

  2. MACE [ Time Frame: 30 days ]
    Cumulative rate of major adverse cardiovascular events (MACE) including cardiac death, myocardial infarction (MI) and repeated revascularization of the target lesion (TLR)

  3. MACE [ Time Frame: 1 year ]
    Cumulative rate of major adverse cardiovascular events (MACE) including cardiac


Secondary Outcome Measures :
  1. Target vessel revascularization [ Time Frame: 30 days ]
    Target vessel revascularization

  2. Percentage of stent struts malposition [ Time Frame: 30 days ]
    Percentage of stent struts malposition

  3. contrast media volume [ Time Frame: 1 day ]
    contrast media volume

  4. Angioplasty time [ Time Frame: 1 day ]
    Angioplasty time


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03475563


Contacts
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Contact: Imanol Otaegui, MD +342746155 iotaegui@vhebron.net
Contact: Imanol Otaegui

Locations
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Spain
Hospital Universitari Parc Taulí Recruiting
Sabadell, Barcelona, Spain, 08208
Contact: Eduard Bosch, MD         
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Imanol Otaegui, MD         
Hospital Universitario de León Recruiting
León, Spain, 24071
Contact: Armando Pérez de Prado, MD, PhD         
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Investigators
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Principal Investigator: Imanol Otaegui, MD Hospital Universitari Vall d'hebron Barcelona, Spain
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT03475563    
Other Study ID Numbers: BIOSS
First Posted: March 23, 2018    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019
Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
Drug-eluting stent
Dedicated bifurcation stent
Cobalt-chromium
Sirolimus-eluting stent
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases