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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| classic strategy | Placebo Comparator | after drug-eluting stent(DES) deployment perform of Intravascular ultrasound analysis without post-dilatation |
|
| post-dilatation strategy | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| post dilatation after stent deployment | Procedure | Post-dilatation with a noncompliant balloon larger 0.25mm than stent balloon. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Georgios SIDERIS, MD | Contact | 33(1) 01-49-95-82-04 | georgios.sideris@lrb.aphp.fr | |
| Olivier VARENNE, MD | Contact | 33(1) 58-41-16-53 | olivier.varenne@cch.aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Georgios SIDERIS, MD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de cardiologie interventionnelle - Hôpital Lariboisière | Recruiting | Paris | 75010 | France |
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| stent deployment without post-dilatation | Procedure | stent deployment without systematic post dilatation |
|