Side Branch Predilatation Strategy in Coronary Bifurcation Lesion Stenting (SBPS)
NCT ID: NCT01430377
Last Updated: 2011-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
120 participants
INTERVENTIONAL
2011-08-31
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SB predilatation
SB predilatation
Initial SB \[predilatation.
No SB predilatation
Without SB predilatation
Interventions
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SB predilatation
Initial SB \[predilatation.
No SB predilatation
Without SB predilatation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
90 Years
ALL
No
Sponsors
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Medica Cor Heart Hospital
OTHER
Responsible Party
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Dobrin Vassilev MD, PhD
Dobrin Vassilev MD, PhD
Locations
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Medica Cor Heart Hospital
Rousse, , Bulgaria
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SBPS
Identifier Type: -
Identifier Source: org_study_id
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