Post-dilatation for Optimization of Drug-eluting Stents (DES) Deployment Assessed by Intravascular Ultrasound Multicenter Analysis

Study Overview
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Brief Summary
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Comparison with use of Intravascular Ultrasound (IVUS) analysis of two methods of percutaneous coronary interventions (PCI) with drug eluting stent: 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.

Detailed Description
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Stent expansion of DES using current stent deliver systems is frequently suboptimal. Further more smaller minimal stent area (MSA) and stent underexpansion following deployment of DES are strong predictors of stent thrombosis and (TVR) target vessel revascularization. The investigators hypothesize than adjunctive postdilatation with noncompliant balloon can improve DES deployment. 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.

Official Title
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A Prospective Randomized Multicenter Study of the Efficacy and Safety of Systematic Post -Dilatation With Noncompliant Balloon After Successful Drug-eluting Stent Implantation. IVUS Analysis.

Conditions
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Implant

Intervention / Treatment
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* Procedure: post dilatation after stent deployment
* Procedure: stent deployment without post-dilatation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Successful drug eluting stent implantation in a native coronary artery Exclusion Criteria: Percutaneous coronary intervention (PCI) of Left main coronary artery; Myocardial infarction; Acute coronary syndrome; Emergency PCI; PCI for in-stent restenosis;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: classic strategy<br>after drug-eluting stent(DES) deployment perform of Intravascular ultrasound analysis without post-dilatation | Procedure: stent deployment without post-dilatation<br>* stent deployment without systematic post dilatation<br>|
| Active Comparator: post-dilatation strategy<br>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. | Procedure: post dilatation after stent deployment<br>* Post-dilatation with a noncompliant balloon larger 0.25mm than stent balloon.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optimal stent deployment defined by IVUS analysis | The primary endpoint is optimum stent deployment. For defining the optimal stent deployment we use the IVUS criteria adopted in the MUSIC study: Complete apposition without underexpansion and with symmetric stent expansion. All patients(group A and B) will have IVUS analysis for defining optimal stent deployment | at 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications of percutaneous coronary intervention (PCI) | Death,Myocardial infarction, coronary dissection, intracoronary thrombosis, target vessel revascularisation. | at day0, at day1, at the end of hospitalisation and year1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-dilatation, noncompliant balloon, optimal stent deployment of drug-eluting stent, Intravascular ultrasound (IVUS), Optimal stent deployment defined by intravascular ultrasound analysis