Incidence and Predictors for Late Acquired Stent Malaposition of Drug-Eluting-Stents With Second-Generation Permanent and Biodegradable Polymer-Coatings - a Prospective, Randomized Comparison Using Optical Coherence Tomography
Sponsor study identifier
interventional
69
1 country
1
Study Start
October 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2013
Actual (reported)Study Completion
August 2013
Actual (reported)The polymers releasing the drug of first-generation drug-eluting stents (DES) may induce allergic reactions and inflammation, resulting in late-acquired stent malaposition (LASM) with uncoverage of struts, and risk of stent thrombosis. The incidence and predictors of LASM in DES with newer-generation polymers designed to improve biocompatibility are unknown.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2013
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2010
Date type not reportedThis date has not been verified as actual or estimated.
August 2013
Actual (reported)August 2013
Actual (reported)December 17, 2013
Actual (reported)December 24, 2013
Actual (reported)Number of stent struts with late acquired malaposition
1 year after stent implantation
number of stent struts with late acquired malaposition
2 years after stent implantation
Patients treated with EES
Patients treated with ZES
Patients treated with BES
Patients treated with EES
Patients treated with ZES
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Device product
Everolimus-Eluting Stent (EES)
The registry describes a device or delivery product. Its exact ingredients and actual exposure require separate evidence.
View registry recordMedical University of Vienna
Vienna, 1090, Austria
Thomas Neunteufl, Prof. Dr.
PI
69 participants (actual enrollment reported by the registry).
First Submitted
December 17, 2013
First Posted
December 24, 2013
Study Start
October 2010
Date type not reportedThis date has not been verified as actual or estimated.
Patients treated with BES
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Primary Completion
August 2013
Actual (reported)Study Completion
August 2013
Actual (reported)Last Updated
December 30, 2013
Record last verified: 2013-12
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Source: ClinicalTrials.gov.
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