Status:
UNKNOWN
BIfurcation Optimal Treatment Strategy With LYMus Eluting Dedicated Bifurcation Versus Convention Stent Randomized Study
Lead Sponsor:
Medica Cor Heart Hospital
Conditions:
Coronary Bifurcation Stenosis
Eligibility:
All Genders
20-90 years
Phase:
PHASE4
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 pr...
Detailed Description
The coronary bifurcation lesions pose a therapeutic problem with high rates of periprocedural complications, higher rates of in-stent restenosis and stent thrombosis. These are lesions where stenting ...
Eligibility Criteria
Inclusion
- 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.
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01430364
Start Date
September 1 2011
End Date
May 1 2014
Last Update
December 25 2013
Active Locations (1)
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1
Medica Cor Heart Hospital
Rousse, Bulgaria, 7000