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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Recherches et etudes en sciences sociales et sante, France.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Recherches et etudes en sciences sociales et sante, France
ClinicalTrials.gov Identifier:
NCT01103765
First received: April 13, 2010
Last updated: June 14, 2011
Last verified: June 2011
  Purpose

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 Intervention Phase
Implant
Procedure: post dilatation after stent deployment
Procedure: stent deployment without post-dilatation
Phase 4

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

Further study details as provided by Recherches et etudes en sciences sociales et sante, France:

Primary Outcome Measures:
  • Optimal stent deployment defined by IVUS analysis [ Time Frame: at 18 months ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Complications of percutaneous coronary intervention (PCI) [ Time Frame: at day0, at day1, at the end of hospitalisation and year1 ] [ Designated as safety issue: Yes ]
    Death,Myocardial infarction, coronary dissection, intracoronary thrombosis, target vessel revascularisation.


Estimated Enrollment: 220
Study Start Date: April 2010
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01103765

Contacts
Contact: Georgios SIDERIS, MD 33(1) 01-49-95-82-04 georgios.sideris@lrb.aphp.fr
Contact: Olivier VARENNE, MD 33(1) 58-41-16-53 olivier.varenne@cch.aphp.fr

Locations
France
Service de cardiologie interventionnelle - Hôpital Lariboisière Recruiting
Paris, France, 75010
Contact: Georgios SIDERIS, MD    33(1) 49-95-82-04    georgios.sideris@lrb.aphp.fr   
Contact: Olivier VARENNE, MD    33(1) 58-41-16-53    olivier.varenne@cch.aphp.fr   
Principal Investigator: Georgios SIDERIS, MD         
Sponsors and Collaborators
Recherches et etudes en sciences sociales et sante, France
Investigators
Principal Investigator: Georgios SIDERIS, MD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Dr Georgios SIDERIS, Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01103765     History of Changes
Other Study ID Numbers: UK0801
Study First Received: April 13, 2010
Last Updated: June 14, 2011
Health Authority: France: Ministry of Health

Keywords provided by Recherches et etudes en sciences sociales et sante, France:
Post-dilatation
noncompliant balloon
optimal stent deployment of drug-eluting stent
Intravascular ultrasound (IVUS)
Optimal stent deployment defined by intravascular ultrasound analysis

Additional relevant MeSH terms:
Dilatation, Pathologic
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 31, 2014