Using intracoronary imaging more often to improve outcomes of complex coronary stenting

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational quality-improvement project using prospectively collected data from the Netherlands Heart Registration (NHR) to compare outcomes when intracoronary imaging is used liberally versus contemporary practice in complex percutaneous coronary interventions. Adult patients treated for complex lesions (left main, severely calcified lesions, chronic total occlusions, ostial or long lesions, bifurcations) who are recorded in the NHR will be included. The NHR data are audited for completeness and quality and include baseline, procedural and outcome measures; informed-consent waiver has been obtained for registry analysis. The project will analyze procedural metrics (for example stent expansion and apposition), and clinical outcomes such as major adverse cardiovascular events to inform practice improvement.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* All patients above the age of 18, included in the Netherlands Heart Registration (NHR) quality database after receiving PCI in complex coronary lesions, will be included in the analyses of this project.
* Meeting one or more of the following complexity criteria:

  * Left main: A stenosis of \>50% and/or a FFR ≤ 0.80 and iFR ≤ 0.89 in the left main.
  * Severely calcified lesion: Defined as use of calcium modification therapy (e.g. cutting balloon, scoring balloon, rotablation, orbital atherectomy, intravascular lithotripsy).
  * Chronic total occlusion: Coronary CTO is defined as an obstruction of the coronary artery with the following classic lesion characteristics:

    * TIMI flow 0
    * Absence of contrast stasis at the site of the proximal capillaries
    * Presence of collateral vessels
    * Estimated occlusion duration of at least 3 months.
  * Ostial lesion: Lesion at the origin (within 5 mm) of a major coronary vessel (LM, LAD, RCX and RCA).
  * Long lesion: A vessel treated with one or multiple stents with a total stent length of ≥38 mm is considered a long lesion.
  * Bifurcation (true): A coronary artery narrowing occurring adjacent to, and/or involving, the origin of a significant side branch ≥ 2.5mm. Only true bifurcation will be included, i.e. medina 1,1,1/1,0,1/0,1,1.
  * In-stent restenosis: A reduction ≥50% of the luminal diameter within the previously stented segment or the vessel segments 5 mm proximal and distal to the stent (the "stent edges"), as assessed by coronary angiography.

Exclusion Criteria:

\- Non complex PCI

Where it's running

• Catharina hospital Eindhoven
  Eindhoven, North Brabant, Netherlands Recruiting

Study contacts

• Study coordinator: Koen Teeuwen, MD PhD
• Email: koen.teeuwen@catharinaziekenhuis.nl
• Phone: + 31 040 239 9111

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• µQFR to check side‑branch narrowing after a single stent in bifurcation coronary arteries

  This study will test whether µQFR from a single angiographic view can correctly detect functionally important side‑branch narrowing after single‑stent treatment in adults with obstructive coronary artery disease involving bifurcations.

  Recruiting Shanghai Zhongshan Hospital · Shanghai, Shanghai Municipality · NCT07116083

• Comparing two methods for treating significant left main coronary artery disease

  This study is testing whether two different ways of treating serious left main coronary artery disease can lead to better heart health for patients over two years.

  Recruiting at 38 sites Asan Medical Center · Hong Kong and 48 other locations · NCT05829889

• μFR-guided Drug-Coated Balloon Angioplasty vs Angiography-guided Angioplasty in Coronary Artery Disease

  This trial tests whether using computational μFR guidance during drug-coated balloon angioplasty is better than standard angiography guidance for people with de novo coronary artery lesions.

  Recruiting Centro Cardiologico Monzino · Cosenza, CS and 3 other locations · NCT07917234

• Gastric Ultrasound Before CABG to See if Heart Function Changes Stomach Contents

  This study checks whether people with weaker heart function before elective CABG have different stomach contents seen on ultrasound.

  Recruiting Adiyaman University · Adıyaman · NCT07898215

• Can preoperative photon-counting CT help predict heart recovery after bypass surgery?

  This observational study tests whether a preoperative photon-counting CT can help predict heart function 3 months after coronary bypass surgery in adults with coronary artery disease.

  Recruiting Chinese PLA General Hospital · Beijing · NCT07883499

• Real-World Drug-Coated Balloon Angioplasty in Coronary Artery Disease

  This registry tests how drug-coated balloons perform in everyday clinical practice for adults with coronary artery disease undergoing PCI.

  Recruiting at 5 sites Hospital Arnau de Vilanova · Mexico City, Mexico City and 4 other locations · NCT07875088

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.