Post-dilatation for Optimization of Drug-eluting Stents (DES) Deployment Assessed by Intravascular Ultrasound Multicenter Analysis (PODIUM)
|ClinicalTrials.gov Identifier: NCT01103765|
Recruitment Status : Unknown
Verified June 2011 by Recherches et etudes en sciences sociales et sante, France.
Recruitment status was: Recruiting
First Posted : April 15, 2010
Last Update Posted : June 16, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Implant||Procedure: post dilatation after stent deployment Procedure: stent deployment without post-dilatation||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||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.|
|Study Start Date :||April 2010|
|Estimated Primary Completion Date :||November 2011|
|Estimated Study Completion Date :||November 2011|
Placebo Comparator: classic strategy
after drug-eluting stent(DES) deployment perform of Intravascular ultrasound analysis without post-dilatation
Procedure: stent deployment without post-dilatation
stent deployment without systematic post dilatation
Active Comparator: 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.
Procedure: post dilatation after stent deployment
Post-dilatation with a noncompliant balloon larger 0.25mm than stent balloon.
- Optimal stent deployment defined by IVUS analysis [ Time Frame: at 18 months ]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
- Complications of percutaneous coronary intervention (PCI) [ Time Frame: at day0, at day1, at the end of hospitalisation and year1 ]Death,Myocardial infarction, coronary dissection, intracoronary thrombosis, target vessel revascularisation.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01103765
|Contact: Georgios SIDERIS, MD||33(1) firstname.lastname@example.org|
|Contact: Olivier VARENNE, MD||33(1) email@example.com|
|Service de cardiologie interventionnelle - Hôpital Lariboisière||Recruiting|
|Paris, France, 75010|
|Contact: Georgios SIDERIS, MD 33(1) 49-95-82-04 firstname.lastname@example.org|
|Contact: Olivier VARENNE, MD 33(1) 58-41-16-53 email@example.com|
|Principal Investigator: Georgios SIDERIS, MD|
|Principal Investigator:||Georgios SIDERIS, MD||Assistance Publique - Hôpitaux de Paris|