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NCT Number: NCT06558474

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Catharina Hospital

Eindhoven, North Brabant, 5623 EJ, Netherlands

Location status: Recruiting

Location contact

Koen Teeuwen, MD, PhD

CONTACT

040-2398360

Konrad van Beek, MD

CONTACT

[email protected]

040 239 9111

About this study

The Netherlands Heart Registration (NHR) is an independent organization in which Dutch hospitals prospectively register standard sets of baseline, procedural and outcome data for all invasive cardiac procedures, including PCI. Data provided to the NHR are extensively checked on completeness and quality, reviewed with audit reports by independent trained research nurses and discussed by cardiologists in registration committees. Multiple audits are conducted annually by the NHR for data validation and verification. A waiver for informed consent for analysis with the data of the NHR data registry is obtained.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Liberal post-dilatation strategy during PCI

Behavioral

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

Primary outcomes

  1. Occurrence of target vessel revascularization, myocardial infarction and all-cause mortality

    Time frame: 30 day

    The primary composite end point of major adverse cardiac events is the occurrence of target vessel revascularization, myocardial infarction and all-cause mortality.

Secondary outcomes

  1. All cause mortality

    Time frame: 30 days, 1 year

    all cause mortality, confirmed by verifying the vital status of a patient in the Personal Records Database.

  2. Target vessel revascularization

    Time frame: 30 days and 1 year

    Target vessel revascularization, defined as a revascularization by percutaneous coronary intervention or coronary artery bypass grafting in the same vessel(s) that had been treated at the index procedure, excluding staged procedures.

  3. Myocardial infarction

    Time frame: 30 day

    Myocardial infarction, defined as an increase and/or decrease in one or more cardiac biomarkers by at least one value above the 99th percentile of the upper limit where at least one of the following symptoms is present: 1) symptoms appropriate to ischemia, 2) new significant ST-segment or T-wave abnormalities or bundle branch block, 3) development of pathological Q-waves on the electrocardiogram (ECG), 4) imaging demonstrated new loss of viable myocardial tissue or new wall motion abnormalities, 5) identification of intracoronary thrombus on angiography or autopsy.

Study contacts

Contact information is provided by the study sponsor or research team.

K Teeuwen, MD, PhD

CONTACT

[email protected]

+ 31 040 239 9111

K.A.J. Beek, MD

CONTACT

[email protected]

+ 31 040 239 9111

Sponsors and collaborators

Lead sponsor

Cathreine BV

Other

Collaborators

  • Medtronic

Registry information

Official study title

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

Acronym: OPTIMIZE-PCI

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Aug 16, 2024
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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