Evaluating complete revascularization in patients with multivessel coronary artery disease

PRospective Evaluation of Complete Revascularization in Patients With multiveSsel Disease Excluding chroNic Total Occlusions

This study is testing if a specific heart procedure can improve health outcomes for people with multiple blocked arteries who experience chest pain or other heart issues.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 609 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Erasmus Medical Center (other)
• Locations: 1 site (Rotterdam, South Holland)
• Trial ID: NCT05230446 on ClinicalTrials.gov

What this trial studies

This prospective, multicenter study aims to assess clinical outcomes following complete revascularization using percutaneous coronary intervention (PCI) and optical coherence tomography (OCT) guidance in patients with multivessel coronary artery disease. The study focuses on individuals presenting with stable angina, silent ischemia, or non-ST segment elevation acute coronary syndrome (NSTE-ACS). The primary endpoint is a composite of major adverse cardiovascular and cerebrovascular events at one year post-procedure, with secondary endpoints extending to five years. Eligible patients include those aged 18 to 85 years with multivessel disease but without chronic total occlusions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 85 years with multivessel coronary artery disease who are suitable for PCI.

Not a fit: Patients with single vessel disease, chronic total occlusions, or those in cardiogenic shock may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve clinical outcomes for patients with multivessel coronary artery disease by optimizing revascularization strategies.

How similar studies have performed: Previous studies have shown promising results with similar revascularization approaches, indicating potential for success in this study.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years, ≤85 years
2. The patient is an acceptable candidate for treatment with a drug eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, manufacturer's Instructions for Use and the Declaration of Helsinki
3. Patient indication, lesion length and vessel diameter of the target lesion(s) are according to the 'Instructions for Use' that comes with every Resolute Onyx (Zotarolimus-Eluting stent) system.
4. The patient is willing and able to cooperate with study procedures and required follow up visits
5. The subject or legal representative has been informed of the nature of the study and agrees to its provisions and has provided an EC approved written informed consent, including data privacy authorization

Exclusion Criteria:

1. Age \<18 years and \> 85 years.
2. Single coronary vessel disease.
3. No left anterior descending lesion.
4. Patients in cardiogenic shock.
5. Patients with STEMI.
6. Presence of a chronic total occlusion (CTO) defined as coronary lesion with Thrombolysis in Myocardial Infarction (TIMI) flow grade 0 on initial angiography present for more than or equal to 3 months.
7. Left main coronary artery disease
8. Patients who cannot give informed consent or have a life expectancy of less than 12 months.
9. Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or to any of the study medications, including both aspirin and P2Y12 inhibitors.
10. Patients with an extreme LAD tortuosity imparing OCT catheter advancement
11. Enrollment in another study with another investigational device or drug trial that has not reached the primary endpoint. The patient may only be enrolled once in the PRESENT study.
12. Previous coronary artery bypass grafting (CABG).
13. Patient requiring additional cardiac surgery within 6 months.
14. Women of childbearing potential who do not have a negative pregnancy test result within 7 days before the procedure, women who are known to be pregnant, or who are breastfeeding.

Where this trial is running

Rotterdam, South Holland

• Erasmus Medical Center — Rotterdam, South Holland, Netherlands (RECRUITING)

Study contacts

• Principal investigator: Roberto Diletti, MD PhD — Erasmus Medical Center
• Study coordinator: Roberto Diletti, MD PhD

Conditions: Multi Vessel Coronary Artery Disease, Non-ST Elevation Myocardial Infarction, Unstable Angina, Stable Angina, Coronary Artery Disease, Percutaneous Coronary Intervention, Optical Coherence Tomography