Post-dilatation for Optimization of Drug-eluting Stents (DES) Deployment Assessed by Intravascular Ultrasound Multicenter Analysis
NCT ID: NCT01103765
Last Updated: 2011-06-16
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
220 participants
INTERVENTIONAL
2010-04-30
2011-11-30
Brief Summary
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After successful drug eluting stent implantation, patients were randomized into two groups: Group A had no further dilatation, and Group B had additional post-dilatation with a noncompliant balloon. The investigators performed IVUS analysis in groups A and B just before randomization and after post-dilatation in group B.
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Detailed Description
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After successful drug eluting stent implantation, patients will be randomized into two groups: Group A with no further dilatation, and Group B with additional post-dilatation with a noncompliant balloon. The investigators will performed IVUS analysis in groups A and B just before randomization and after post-dilatation in group B. Post dilatation will be performed with noncompliant balloon and with a nominal diameter 0.25mm larger than stent balloon.
The primary endpoint is optimum stent deployment. For defining the optimal stent deployment the investigators use the IVUS criteria adopted in the MUSIC study: Complete apposition without underexpansion and with symmetric stent expansion.
Patients are eligible after successful drug-eluting stent implantation in a native coronary artery. Patients with myocardial infarction or acute coronary syndrome will be excluded from the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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classic strategy
after drug-eluting stent(DES) deployment perform of Intravascular ultrasound analysis without post-dilatation
stent deployment without post-dilatation
stent deployment without systematic post dilatation
post-dilatation strategy
After drug-eluting stent (DES) deployment IVUS analysis and systematic post-dilatation with noncompliant balloon 0.25mm larger than stent balloon. After post dilatation new IVUS analysis.
post dilatation after stent deployment
Post-dilatation with a noncompliant balloon larger 0.25mm than stent balloon.
Interventions
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post dilatation after stent deployment
Post-dilatation with a noncompliant balloon larger 0.25mm than stent balloon.
stent deployment without post-dilatation
stent deployment without systematic post dilatation
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Myocardial infarction;
* Acute coronary syndrome;
* Emergency PCI;
* PCI for in-stent restenosis;
18 Years
75 Years
ALL
No
Sponsors
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Recherches et etudes en sciences sociales et sante, France
NETWORK
Responsible Party
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Assistance Publique - Hôpitaux de Paris
Principal Investigators
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Georgios SIDERIS, MD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Service de cardiologie interventionnelle - Hôpital Lariboisière
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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UK0801
Identifier Type: -
Identifier Source: org_study_id
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