Using intracoronary imaging more often to improve outcomes of complex coronary stenting
Optimization of Complex Percutaneous Coronary Intervention With Liberal Use of Intracoronary Imaging Versus Contemporary Practice
This project tests whether more frequent use of intracoronary imaging during complex stenting procedures for adults with complicated coronary artery disease leads to better stent results and fewer major complications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 11092 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cathreine BV Academic / other |
| Locations | 1 site (Eindhoven, North Brabant) |
| Trial ID | NCT07114393 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (age ≥18) in the Netherlands undergoing PCI for complex coronary lesions recorded in the NHR—such as left main disease, severe calcification, chronic total occlusion, ostial or long lesions, or bifurcation disease—are the intended participants.
Not a fit: Patients with simple, non-complex coronary lesions, those not undergoing PCI, or patients treated outside participating Dutch centers or not entered in the NHR are unlikely to benefit from this registry project.
Why it matters
Potential benefit: If successful, wider use of intracoronary imaging could lead to better stent expansion and fewer repeat heart procedures or major cardiac events for patients with complex coronary disease.
How similar studies have performed: Previous randomized trials and studies of intracoronary imaging in complex PCI have shown improved stent expansion and reductions in major adverse cardiovascular events, so this work builds on existing successful evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Eindhoven, North Brabant
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.