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

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.

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.

Study Overview

• Status: Unknown
• Conditions: Implant
• Intervention / Treatment: Procedure: stent deployment without post-dilatation; Procedure: post dilatation after stent deployment

Detailed Description

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
• Enrollment (Anticipated): 220
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Paris, France, 75010
    • Recruiting
    • Service de cardiologie interventionnelle - Hôpital Lariboisière
    • Contact: Olivier VARENNE, MD; Phone Number: 33(1) 58-41-16-53; Email: olivier.varenne@cch.aphp.fr
    • Contact: Georgios SIDERIS, MD; Phone Number: 33(1) 49-95-82-04; Email: georgios.sideris@lrb.aphp.fr
    • Principal Investigator: Georgios SIDERIS, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Recherches et etudes en sciences sociales et sante, France
• Investigators: Principal Investigator: Georgios SIDERIS, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Anticipated): November 1, 2011
• Study Completion (Anticipated): November 1, 2011

Study Registration Dates

• First Submitted: April 13, 2010
• First Submitted That Met QC Criteria: April 14, 2010
• First Posted (Estimate): April 15, 2010

Study Record Updates

• Last Update Posted (Estimate): June 16, 2011
• Last Update Submitted That Met QC Criteria: June 14, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Intravascular ultrasound (IVUS); Post-dilatation; noncompliant balloon; optimal stent deployment of drug-eluting stent; Optimal stent deployment defined by intravascular ultrasound analysis
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Dilatation, Pathologic
• Other Study ID Numbers: UK0801