NCT06558474 Optimization of Percutaenous Coronary Intervention With Liberal Use of Post-dilatation
| NCT ID | NCT06558474 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cathreine BV |
| Condition | Coronary Artery Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 12,000 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2025-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 12,000 participants in total. It began in 2023-09-01 with a primary completion date of 2025-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: \- If a patient has multiple PCIs within 365 days, only the first procedure is included.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06558474 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06558474 currently recruiting?
Yes, NCT06558474 is actively recruiting participants. Contact the research team at koen.teeuwen@catharinaziekenhuis.nl for enrollment information.
Where is the NCT06558474 trial being conducted?
This trial is being conducted at Eindhoven, Netherlands.
Who is sponsoring the NCT06558474 clinical trial?
NCT06558474 is sponsored by Cathreine BV. The trial plans to enroll 12,000 participants.