Catharina Hospital
Eindhoven, North Brabant, 5623 EJ, Netherlands
Location status: Recruiting
Location contact
Koen Teeuwen, MD, PhD
CONTACT
Konrad van Beek, MD
CONTACT
NCT Number: NCT06558474
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Eindhoven, North Brabant, 5623 EJ, Netherlands
Location status: Recruiting
Koen Teeuwen, MD, PhD
CONTACT
Konrad van Beek, MD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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:
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.
Time frame: 30 days, 1 year
all cause mortality, confirmed by verifying the vital status of a patient in the Personal Records Database.
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.
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.
Contact information is provided by the study sponsor or research team.
K Teeuwen, MD, PhD
CONTACT
K.A.J. Beek, MD
CONTACT
Cathreine BV
Other
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
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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