NCT06558474Recruiting
Optimization of Percutaenous Coronary Intervention With Liberal Use of Post-dilatation
Optimization of Percutaneous Coronary Intervention After Stent Implantation With Liberal Use of High-pressure Non-compliant Balloon Post-dilatation Versus Contemporary Practice
Source: ClinicalTrials.gov · Last updated 7 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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. 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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 12000 (estimated)
- First submitted
- 14 Aug 2024
- Start date
- 1 Sept 2023
- Primary completion date
- 1 Jun 2025
- Lead sponsor
- Cathreine BV
- Diseases
- Coronary artery disease
- NCT number
- NCT06558474
What you commit to
- Study type: Observational
- Planned participants: 12000
- From 1 Sept 2023 to the primary completion date, 1 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- \- If a patient has multiple PCIs within 365 days, only the first procedure is included.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Catharina hospital Coordinator of this site? Confirm its status | Eindhoven | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.