Optical Coherence Tomography Evaluation of a Biodegradable Polymer-based Drug-eluting Stent
NCT ID: NCT01060306
Last Updated: 2020-02-24
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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WITHDRAWN
OBSERVATIONAL
2010-01-31
2011-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Bare metal stent 1 month
Patients implanted with the bare metal stent Gazelle evaluated for neointimal coverage one month after implantation
No interventions assigned to this group
Biodegradable polymer stent 6 months
Patients implanted with the biodegradable polymer-based Biolimus A9-eluting stent (Biomatrix stent) evaluated for neointimal coverage after full drug elution and polymer biodegradation (6 months)
No interventions assigned to this group
Biodegradable polymer stent 7 months
Patients implanted with the biodegradable polymer-based Biolimus A9-eluting stent (Biomatrix stent) evaluated for neointimal coverage one month after full drug elution and polymer biodegradation (7 months)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* de novo lesion
* lesion length \<24 mm
* reference vessel diameter 3 mm
Exclusion Criteria
* life expectancy \<1 year
* allergy to any drug or substance use prior, during or after percutaneous coronary intervention
* chronic renal insufficiency
* low left ventricle ejection fraction (\<35%)
* recent acute myocardial infarction
* previous coronary intervention
* off-label indication to stenting
* participation in another investigation
* refusal to participate to the study
50 Years
85 Years
ALL
No
Sponsors
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Ospedale Santa Maria Goretti
OTHER
Responsible Party
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Gregory Sgueglia, MD
MD, PhD
Locations
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UOC Emodinamica e Cardiologia Interventistica - Ospedale Santa Maria Goretti
Latina, , Italy
Countries
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Other Identifiers
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SMG-005
Identifier Type: -
Identifier Source: org_study_id
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