ImplantPhase 4PODIUMNCT01103765
Post-dilatation for Optimization of Drug-eluting Stents (DES) Deployment Assessed by Intravascular Ultrasound Multicenter Analysis
A Phase 4 study testing post dilatation after stent deployment and stent deployment without post-dilatation in people with Implant, run by Recherches et etudes en sciences sociales et sante, France at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Implant
- What is being tested?
- post dilatation after stent deployment and stent deployment without post-dilatation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2010to Nov 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Successful drug eluting stent implantation in a native coronary artery
Who cannot join
- Percutaneous coronary intervention (PCI) of Left main coronary artery;
- Myocardial infarction;
- Acute coronary syndrome;
- Emergency PCI;
- PCI for in-stent restenosis;
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de cardiologie interventionnelle - Hôpital Lariboisière
Paris, 75010
Georgios SIDERIS, MD, 33(1) 49-95-82-04, georgios.sideris@lrb.aphp.fr
Olivier VARENNE, MD, 33(1) 58-41-16-53, olivier.varenne@cch.aphp.fr
About this study
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.
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.
Read the 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.
- Conditions
- Implant
- Being tested
- post dilatation after stent deployment, stent deployment without post-dilatation
- Keywords
- Post-dilatation, noncompliant balloon, optimal stent deployment of drug-eluting stent, Intravascular ultrasound (IVUS), Optimal stent deployment defined by intravascular ultrasound analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
post dilatation after stent deploymentProcedure or surgery
Post-dilatation with a noncompliant balloon larger 0.25mm than stent balloon.
stent deployment without post-dilatationProcedure or surgery
stent deployment without systematic post dilatation
| Study group | Role | What they receive |
|---|---|---|
| classic strategy | Placebo comparator | after drug-eluting stent(DES) deployment perform of Intravascular ultrasound analysis without post-dilatation Receives: Procedure: stent deployment 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. Receives: Procedure: post dilatation after stent deployment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 18 months
Secondary outcomes (1)
Complications of percutaneous coronary intervention (PCI)
Death,Myocardial infarction, coronary dissection, intracoronary thrombosis, target vessel revascularisation.
Measured: at day0, at day1, at the end of hospitalisation and year1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionNov 2011 (estimated)
- Study completionNov 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Recherches et etudes en sciences sociales et sante, France
- Sponsor type
- Research network
- Investigators
- Georgios SIDERIS, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01103765
- Sponsor's protocol ID
- UK0801
- Acronym
- PODIUM
- Status last verified
- Jun 2011
- First submitted
- 13 Apr 2010
- Last updated
- 16 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01103765
- Acronym / sponsor ID
- PODIUM / UK0801
- Conditions
- Implant
- Keywords
- Post-dilatation, noncompliant balloon, optimal stent deployment of drug-eluting stent, Intravascular ultrasound (IVUS), Optimal stent deployment defined by intravascular ultrasound analysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Recherches et etudes en sciences sociales et sante, FranceResearch network
- Study start
- Apr 2010
- Primary completion
- Nov 2011 (estimated)
- Study completion
- Nov 2011 (estimated)
- First posted
- 15 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| classic strategy | Placebo comparator | Procedure: stent deployment without post-dilatationafter drug-eluting stent(DES) deployment perform of Intravascular ultrasound analysis without post-dilatation |
| post-dilatation strategy | Active comparator | Procedure: post dilatation after stent deploymentAfter 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Successful drug eluting stent implantation in a native coronary artery
Key exclusion criteria (5 listed)
- Percutaneous coronary intervention (PCI) of Left main coronary artery;
- Myocardial infarction;
- Acute coronary syndrome;
- Emergency PCI;
- PCI for in-stent restenosis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| post dilatation after stent deploymentPost-dilatation with a noncompliant balloon larger 0.25mm than stent balloon. | Procedure or surgery | post-dilatation strategy |
| stent deployment without post-dilatationstent deployment without systematic post dilatation | Procedure or surgery | classic strategy |
Primary outcome
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
1 secondary outcome
Complications of percutaneous coronary intervention (PCI)
Time frame: at day0, at day1, at the end of hospitalisation and year1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georgios SIDERIS, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing post dilatation after stent deployment and stent deployment without post-dilatation in people with Implant, run by Recherches et etudes en sciences sociales et sante, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Georgios SIDERIS, MD (33(1) 01-49-95-82-04, georgios.sideris@lrb.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal stent deployment defined by IVUS analysis (time frame: at 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2011.