Liberal balloon widening after stent placement in coronary artery disease procedures
Studies wider balloon use after stenting in adults with coronary artery disease.
Key facts
- Who runs it
- Cathreine BV
- Where
- Eindhoven, NetherlandsSee the site
- Trial code
- Registry title
- Optimization of Percutaenous Coronary Intervention With Liberal Use of Post-dilatation
- Status
- Recruiting
- People taking part
- 12,000 people, planned
- Started
- 1 Sept 2023
- Planned end
- 1 May 2026
- Type of study
- Observational, 2 groups
- Treatments tested
- Liberal post-dilatation strategy during PCI
- Record updated
- 7 August 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial uses a national heart registry in the Netherlands. It includes adults who have a procedure to open blocked heart arteries (PCI), for any reason.
- Age
- Older than 18 years
- Sex
- All sexes
- Disease stage
- Any reason for having PCI
Main reasons for not taking part
- If a person has more than one PCI within 365 days, only the first procedure is included.
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- All patients >18 years old who undergo PCI for any indication are included in the register of the Netherlands Heart Registration and therefore included in the final analysis of this project
Who cannot take part
- If a patient has multiple PCIs within 365 days, only the first procedure is included
Where in Netherlands
- Catharina hospitalEindhoven, NetherlandsContact: Koen Teeuwen, MD, PhDTaking people
About the trial
What the trial wants to find out
To achieve optimal long-term clinical results after percutaneous coronary intervention (PCI), adequate deployment of stents is essential. Thorough expansion of the stent and full apposition of stent struts against the vessel wall are determining factors for preventing stent thrombosis and restenosis for bare-metal as well as drug-eluting stents (DES). Standard coronary angiography is limited in assessing accurate vessel size and characterizing tissues and calcium load. Therefore, stent underexpansion frequently occurs after stent deployment.
Read full original descriptionShow less
Post-dilation is often performed to achieve optimal stent expansion and reduce stent malapposition of stent struts, aiming to reduce stent thrombosis and restenosis both short term as long term. However, there are limited studies that have explored the effect of post-dilatation for stent optimization on clinical outcomes. As a result of the restricted evidence, there is no consensus whether post-dilatation should be used routinely in clinical practice and the extent to which post-dilatation is being utilized remains unclear.
For this reason, the OPTIMIZE PCI was designed, a national registry-based quality improvement project to implement a liberal post-dilatation strategy in multiple PCI centers in the Netherlands. As part of the OPTIMIZE-PCI, a retrospective observational analysis will eventually be conducted to evaluate whether adopting this strategy has led to improved clinical outcomes after PCI in terms of major adverse cardiac events.
The 2 groups in the trial
- Pre-intervention/implementation cohort
In the first phase, data additional to the national PCI registry will be analyzed retrospectively from all patients receiving PCI from January 2021 to January 2022. Data on the percentage of use of post-dilatation using high-pressure non-compliant (HPNC) balloon by the individual interventional cardiologist will be collected. This will establish a benchmark from which individual interventional cardiologists must increase their use of post-dilatation.
- Post-intervention/implementation cohort
During this implementation phase, all individual PCI operators of the participating centres will be informed to liberally use post-dilatation for stent optimization during PCI. Operators are requested to increase their use of post-dilatation with at least 20% or use post-diltation in at least 85% of the PCI's. Throughout the project, individual participating operators will receive individual feedback on the percentage use of post-dilatation with prospective data collection after 2, 4, 6, 9 and 12 months. Based on this result, the implementation process will be refined as necessary. The duration of this phase will be approximately 1 year per centre. Eventually a retrospective observational anlaysis, comparing the two cohorts, will be conducted to evaluate whether adopting this strategy has led to improved clinical outcomes after PCI in terms of major adverse cardiac events.
Treatment: Liberal post-dilatation strategy during PCI
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Optimization of Percutaneous Coronary Intervention After Stent Implantation With Liberal Use of High-pressure Non-compliant Balloon Post-dilatation Versus Contemporary Practice
- Plain-language title
- Liberal balloon widening after stent placement in coronary artery disease proceduresGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 7 August 2025