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

Implant Clinical Trial

— PODIUM  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01103765
• Other study ID #: UK0801
• Status: Recruiting
• Phase: Phase 4
• First received: April 13, 2010
• Last updated: June 14, 2011
• Start date: April 2010
• Est. completion date: November 2011

Study information

• Verified date: June 2011
• Source: Recherches et etudes en sciences sociales et sante, France
• Contact: Georgios SIDERIS, MD
• Phone: 33(1) 01-49-95-82-04
• Email: georgios.sideris[@]lrb.aphp.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Implant

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
France	Service de cardiologie interventionnelle - Hôpital Lariboisière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Recherches et etudes en sciences sociales et sante, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes