Actively Recruiting

Age: 18Years +
All Genders
NCT06558474

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

Led by Cathreine BV · Updated on 2025-08-07

12000

Participants Needed

1

Research Sites

139 weeks

Total Duration

On this page

Sponsors

C

Cathreine BV

Lead Sponsor

M

Medtronic

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • All patients older than 18 years who undergo PCI for any reason are included in the Netherlands Heart Registration and in the study analysis
Not Eligible

You will not qualify if you...

  • Only the first PCI procedure is included if a patient has multiple PCIs within 365 days

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Catharina Hospital

Eindhoven, North Brabant, Netherlands, 5623 EJ

Actively Recruiting

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Research Team

K

K Teeuwen, MD, PhD

CONTACT

K

K.A.J. Beek, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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