A Comparison Between Paclitaxel-eluting Balloon in Combination With BMS Implantation vs Conventional Balloon and DES Implantation
NCT ID: NCT01637896
Last Updated: 2012-07-12
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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TERMINATED
PHASE4
125 participants
INTERVENTIONAL
2010-06-30
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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DEB+BMS
drug-eluting balloon predilation and bare metal stent implantation
DEB+BMS
drug-eluting balloon predilation and bare metal stent implantation
POBA+DES
conventional balloon predilation and drug-eluting stent implantation
POBA+DES
conventional balloon predilation and drug-eluting stent implantation
Interventions
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DEB+BMS
drug-eluting balloon predilation and bare metal stent implantation
POBA+DES
conventional balloon predilation and drug-eluting stent implantation
Eligibility Criteria
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Inclusion Criteria
* angina or stress test positive for ischemia
* de novo coronary stenosis\>50%
Exclusion Criteria
* severe chronic kidney disease
* allergy to Paclitaxel
* contraindication for combined antiplatelet treatment
* life expectancy \<1 year
* hypersensitivity or contraindication to one of the study drugs
* lack of consent
18 Years
ALL
No
Sponsors
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Leonardo Bolognese, MD
OTHER
Responsible Party
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Leonardo Bolognese, MD
Director
Principal Investigators
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Leonardo Bolognese, MD
Role: PRINCIPAL_INVESTIGATOR
San Donato Hospital
Locations
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Cardiovascular Department, Ospedale S.Donato
Arezzo, AR, Italy
Countries
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Other Identifiers
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Arezzo000
Identifier Type: -
Identifier Source: org_study_id