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BIfurcation Optimal Treatment Strategy With LYMus Eluting Dedicated Bifurcation Versus Convention Stent Randomized Study (BIOSS LIM)

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ClinicalTrials.gov Identifier: NCT01430364
Recruitment Status : Unknown
Verified December 2013 by Medica Cor Heart Hospital.
Recruitment status was:  Recruiting
First Posted : September 8, 2011
Last Update Posted : December 25, 2013
Sponsor:
Information provided by (Responsible Party):
Medica Cor Heart Hospital

Brief Summary:
Study aims: to compare two intervention strategies for bifurcation treatment - provisional T-stenting (PTS) with drug-eluting stent (sirolimus eluting), with kissing balloon inflation at the end of procedure - the best treatment strategy at the moment, with stenting of bifurcation lesions with dedicated bifurcation drug-eluting stent BiOSS Lym.

Condition or disease Intervention/treatment Phase
Coronary Bifurcation Stenosis Device: BIOSS LIM implantation Device: BIOSS Lim Device: CarloS Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: BIfurcation Optimal Treatment Strategy With LIMus Eluting Dedicated Bifurcation Versus Convention Stent Randomized Study
Study Start Date : September 2011
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : May 2014

Arm Intervention/treatment
Active Comparator: BIOSS implantation Device: BIOSS LIM implantation
BIOSS LIM is a dedicated bifurcation stent system with sirolymus elution.
Device: BIOSS Lim Device: CarloS



Primary Outcome Measures :
  1. Major adverse cardiac events (MACE) [ Time Frame: 12 months ]
    death, myocardial infarction (MI), target vessel revascularization (TVR)


Secondary Outcome Measures :
  1. Target lesion revascularization (TLR) [ Time Frame: 12 months ]
    Clinically driven revascularization rates.



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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  1. Inclusion Criteria

    • Subject at least 18 years of age.
    • Subject able to verbally confirm understandings of risks, benefits of receiving PCI for true bifurcation lesions, and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
    • Target main branch lesion(s) located in a native coronary artery with diameter of ≥ 2.5 mm and ≤ 4.5 mm. Target side branch lesion(s) located in a native coronary artery with diameter of ≥ 2.0 mm.
    • Target lesion(s) amenable for PCI with balloon angioplasty of the side branch.
  2. Exclusion Criteria

    • STEMI
    • Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
    • Subjects who refuse to give informed consent.
    • Subjects with LVEF<30%
    • Subjects with moderate or severe degree valvular heart disease or primary cardiomyopathy
    • Contraindications for 12 months DAP

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): NCT01430364


Contacts
Contact: Dobrin Vassilev, MD, PhD 00359886846550 dobrinv@gmail.com
Contact: Kristiyan Ivanov, MD 00359884460101 kristik@abv.bg

Locations
Bulgaria
Medica Cor Heart Hospital Recruiting
Ruse, Bulgaria, 7000
Contact: Dobrin Vassilev, MD, PhD    00359886846550    dobrinv@gmail.com   
Contact: Kristiyan Ivanov, MD    00359884460101    kristik@abv.bg   
Sponsors and Collaborators
Medica Cor Heart Hospital

Responsible Party: Medica Cor Heart Hospital
ClinicalTrials.gov Identifier: NCT01430364     History of Changes
Other Study ID Numbers: BIOSS LIM
First Posted: September 8, 2011    Key Record Dates
Last Update Posted: December 25, 2013
Last Verified: December 2013

Keywords provided by Medica Cor Heart Hospital:
coronary bifurcation stenosis
dedicated bifurcation stent
sirolymus
PTS
BiOSS Lym