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RECRUITING
NCT06558474

Optimization of Percutaenous Coronary Intervention With Liberal Use of Post-dilatation

Sponsor: Cathreine BV

View on ClinicalTrials.gov

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.

Official title: Optimization of Percutaneous Coronary Intervention After Stent Implantation With Liberal Use of High-pressure Non-compliant Balloon Post-dilatation Versus Contemporary Practice

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

12000

Start Date

2023-09-01

Completion Date

2026-05-01

Last Updated

2025-08-07

Healthy Volunteers

No

Interventions

BEHAVIORAL

Liberal post-dilatation strategy during PCI

A liberal post-dilatation strategy for stent optimization during PCI will be implemented in multiple centers in the Netherlands. This include an increase of post-dilatation use of at least 20% per operator, or a percentage of post-dilatation of at least 85%. Operators will be asked to enforce a very low threshold for post-dilatation in general, with a mandatory HPNC post-dilatation for the following indications: * In case of any calcification * Delta of ≥ 0.5mm between the distal and proximal reference diameter of the treated coronary segment * Stent length \>24 mm * Signs of incomplete stentframe-deployment on angiography or StentBoost * In case of CTO * In case of bifurcation PCI (Left main and non-left main) * Proximal Optimisation Technique (POT) with NC balloon * Final Kissing Balloon dilatation (FKB) with preferentially first sequential high-pressure inflations and final low pressure kiss both with NC balloons

Locations (1)

Catharina Hospital

Eindhoven, North Brabant, Netherlands