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

This study is currently recruiting participants.
Verified September 2012 by Medica Cor Heart Hospital
Sponsor:
Information provided by (Responsible Party):
Medica Cor Heart Hospital
ClinicalTrials.gov Identifier:
NCT01430364
First received: September 3, 2011
Last updated: September 12, 2012
Last verified: September 2012
History of Changes
  Purpose

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 Intervention Phase
Coronary Bifurcation Stenosis
 Device: BIOSS LIM implantation
Device: BIOSS Lim
Device: CarloS
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: BIfurcation Optimal Treatment Strategy With LIMus Eluting Dedicated Bifurcation Versus Convention Stent Randomized Study

Further study details as provided by Medica Cor Heart Hospital:

Primary Outcome Measures:
  • Major adverse cardiac events (MACE) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    death, myocardial infarction (MI), target vessel revascularization (TVR)


Secondary Outcome Measures:
  • Target lesion revascularization (TLR) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Clinically driven revascularization rates.


Estimated Enrollment: 60
Study Start Date: September 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: BIOSS implantation Device: BIOSS LIM implantation
BIOSS LIM is a dedicated bifurcation stent system with sirolymus elution.
Device: BIOSS Lim Device: CarloS

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Medica Cor Heart Hospital
ClinicalTrials.gov Identifier: NCT01430364     History of Changes
Other Study ID Numbers: BIOSS LIM
Study First Received: September 3, 2011
Last Updated: September 12, 2012
Health Authority: Bulgaria: Ethics committee

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

Additional relevant MeSH terms:
Constriction, Pathologic
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 22, 2013