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

Recruiting now · Not applicable

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

In brief

This prospective, multicenter, non-randomized, single arm, objective performance goal (OPG) study is designed to evaluate clinical outcomes after complete revascularization by PCI and imaging guidance (OCT) in patients with multivessel coronary artery disease including left anterior descending (LAD) presenting with stable angina, or documented silent ischemia, or non-ST segment elevation acute coronary syndrome (NSTE-ACS).

Key facts

Study ID

NCT05230446

Run by

Erasmus Medical Center

People needed

609

Starts

2021-11-18

Expected to finish

2027-11-18

Last updated by the study team

2022-02-09

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years, ≤85 years
• 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
• 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.
• The patient is willing and able to cooperate with study procedures and required follow up visits
• 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

You may not qualify if…

• Age <18 years and > 85 years.
• Single coronary vessel disease.
• No left anterior descending lesion.
• Patients in cardiogenic shock.
• Patients with STEMI.
• 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.
• Left main coronary artery disease
• Patients who cannot give informed consent or have a life expectancy of less than 12 months.
• 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.
• Patients with an extreme LAD tortuosity imparing OCT catheter advancement
• 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.
• Previous coronary artery bypass grafting (CABG).
• Patient requiring additional cardiac surgery within 6 months.
• 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 it is running

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

Full record on ClinicalTrials.gov

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