Status:
UNKNOWN
Side Branch Predilatation Strategy in Coronary Bifurcation Lesion Stenting (SBPS)
Lead Sponsor:
Medica Cor Heart Hospital
Conditions:
Coronary Ostium Stenosis
Myonecrosis
Eligibility:
All Genders
20-90 years
Phase:
PHASE4
Brief Summary
The role of Side Branch (SB) predilatation during coronary bifurcation lesion percutaneous coronary intervention (PCI) is still not established. The predilatation could potentially damage SB ostium by...
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
- ST-segment elevation myocardial infarction (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 left ventricle ejection fraction \<30%
- Subjects with moderate or severe degree valvular heart disease or primary cardiomyopathy
- Contraindications for 12 months double antiplatelet therapy
Exclusion
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2012
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01430377
Start Date
August 1 2011
End Date
May 1 2012
Last Update
September 8 2011
Active Locations (1)
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1
Medica Cor Heart Hospital
Rousse, Bulgaria, 7000