Optimization of Complex Percutaneous Coronary Intervention With Liberal Use of Intracoronary Imaging Versus Contemporary Practice

NCT07114393 | Recruiting

• 1 other identifier: CathreineBV-OP2
• Study Type: observational
• Target: 11,092
• Locations: 1 country
• Sites: 1

Brief Summary

Coronary artery disease remains a leading cause of mortality worldwide and is commonly treated with percutaneous coronary intervention (PCI). Typically, PCI is guided by invasive coronary angiography (ICA). However, ICA has inherent limitations in accurately assessing vessel dimensions, calcium burden, circumferential tissue and whether a stent has achieved full expansion. Therefore ICA alone is insufficient for guiding stent optimization, especially in complex lesions which are most vulnerable to long-term stent failure. To overcome the limitations of ICA, intracoronary imaging can be used to guide and optimize PCI. The advantages of intracoronary imaging include obtaining larger lumen areas, better stent expansion and strut apposition, full lesion stent coverage and identifying stent complications. Multiple randomized studies have shown that these advantages translate into a reduction in major adverse cardiovascular events (MACE) in complex PCI. Consequently, the recommendation for intracoronary imaging has been upgraded in the most recent guidelines. Despite robust evidence supporting its benefits, intracoronary imaging remains relatively underused in real-world practice and in the Netherlands it is only used in 7% of complex PCI procedures. This underutilization may be attributed to several factors, including operator and hospital-dependent issues such as lack of experience, reluctance to spend additional time on intracoronary imaging and concerns about its cost-effectiveness. Therefore, initiating an implementation project to incorporate intracoronary imaging into routine use in the catheterization lab during complex PCI would be highly valuable. Such a project could make imaging-guided PCI the standard of care in complex PCI. Additionally, it could evaluate the cost-effectiveness of routine intracoronary imaging during complex PCI. For this reason we designed the OPTIMIZE-PCI II, a national registry-based quality improvement project. This project is aimed at implementing a liberal intracoronary imaging-guided strategy for complex PCI across multiple centres in the Netherlands, with data extraction from the Netherlands Heart Registration (NHR) database. The objective of the OPTIMIZE-PCI II is to establish a routine use of intracoronary imaging in complex PCI, to determine if this approach reduces adverse cardiac events in real-world practice, and evaluate its cost-effectiveness.

Conditions

Chronic Total Occlusion (CTO); Bifurcation Coronary Artery Disease; Coronary Artery Disease; Coronary Artery Disease (Left Main)

Keywords

percutaneous coronary intervention; intracoronary imaging; stent optimization; complex coronary artery disease

Outcome Measures

Primary Outcomes (1)

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

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

  1 year

Secondary Outcomes (5)

• Occurrence of all cause mortality

  30 days, 1 year

• Occurrence of target vessel revascularization

  30 days and 1 year

• Occurrence of myocardial infarction

  30 days 1 year

• Occurrence of stent thrombosis

  30 days, 1 year

• Occurrence of target lesion revascularization

  30 days, 1 year

Study Arms (2)

Pre-implementation cohort

This group will serve as the control cohort before implementation of a new intracoronary imaging protocol. Data from the national PCI registry, which will be supplemented with an additional set of procedural variables. Data on the percentage of use of intracoronary imaging in complex coronary lesions by the individual interventional cardiologist will be collected. This will establish a benchmark from which individual interventional cardiologists must increase their use of intracoronary imaging. This will be the pre-implementation cohort that will be used as the comparator in the final evaluation.

Post-implementation cohort

This is the cohort in which a new intracoronary imaging protocol will be implemented. Main goal of this protocol is the increase the use of intracoronary imaging during complex PCI in the Netherlands. The duration of this phase will be approximately 1-2 year.

Behavioral: Liberal use of intracoronary imaging during complex PCI

Interventions

Liberal use of intracoronary imaging during complex PCI BEHAVIORAL

A new protocol regarding use of intracoronary imaging will be implemented in multiple PCI centers in the Netherlands. Main goal of this protocol will be to increase the use of imaging in complex PCI in the Netherlands. Moreover operators will be trained according to the new protocol and on site training will be organized to improve the skills in using imaging during complex PCI.Operators are requested to use of intracoronary imaging preferentially in all complex coronary lesions, but at least increase their use with at least 50% and minimum of 25% of the cases. Throughout the second phase, individual participating operators will receive personalized feedback on their use of intracoronary imaging at multiple intervals. Based on this result, the implementation process will be refined as necessary. These intermediate measurements will also be shared with all participating centres anonymous.

Post-implementation cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population exists of patients registered in our national PCI registration of the Netherlands Heart Registration after receiving complex PCI. All indications are included (ACS and non-ACS, OHCA, cardiogenic shock).

You may qualify if:

• 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.

You may not qualify if:

• \- Non complex PCI

Sponsors & Collaborators

• Salveo Diagnostics: collaborator
• Boston Scientific Corporation: collaborator
• Abbott Medical Devices: collaborator
• Cathreine BV: lead
• Philips Healthcare: collaborator

Study Sites (1)

Catharina hospital Eindhoven

Eindhoven, North Brabant, 5623EJ, Netherlands

RECRUITING

Related Publications (4)

• Koskinas KC, Nakamura M, Raber L, Colleran R, Kadota K, Capodanno D, Wijns W, Akasaka T, Valgimigli M, Guagliumi G, Windecker S, Byrne RA. Current use of intracoronary imaging in interventional practice - Results of a European Association of Percutaneous Cardiovascular Interventions (EAPCI) and Japanese Association of Cardiovascular Interventions and Therapeutics (CVIT) Clinical Practice Survey. EuroIntervention. 2018 Jul 20;14(4):e475-e484. doi: 10.4244/EIJY18M03_01.

  PMID: 29537966 BACKGROUND

• Bresnahan JF, Kitchell BB, Wildman MF. Facial hair barbering in rats. Lab Anim Sci. 1983 Jun;33(3):290-1.

  PMID: 6876735 BACKGROUND

• Stone GW, Christiansen EH, Ali ZA, Andreasen LN, Maehara A, Ahmad Y, Landmesser U, Holm NR. Intravascular imaging-guided coronary drug-eluting stent implantation: an updated network meta-analysis. Lancet. 2024 Mar 2;403(10429):824-837. doi: 10.1016/S0140-6736(23)02454-6. Epub 2024 Feb 21.

  PMID: 38401549 BACKGROUND

• van Beek KAJ, Timmermans MJC, Derks L, Cheng JM, Kraaijeveld AO, Arkenbout EK, Schotborgh CE, Brouwer J, Claessen BE, Lipsic E, Polad J, van Nunen LX, Sjauw K, van Veghel D, Tonino PA, Teeuwen K; 'on behalf of the PCI registration committee of The Netherlands Heart Registration'. Contemporary Use of Post-Dilatation for Stent Optimization During Percutaneous Coronary Intervention; Results From the Netherlands Heart Registration. Catheter Cardiovasc Interv. 2025 Mar;105(4):870-877. doi: 10.1002/ccd.31404. Epub 2025 Jan 8.

  PMID: 39777867 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Koen Teeuwen, MD PhD

CONTACT

+ 31 040 239 9111; koen.teeuwen@catharinaziekenhuis.nl

Konrad AJ van Beek, MD

CONTACT

+ 31 040 239 9111; konrad.v.beek@catharinaziekenhuis.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 11, 2025
• Study Start: April 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

NL (1)