NCT05230446 PRospective Evaluation of Complete Revascularization in Patients With multiveSsel Disease Excluding chroNic Total Occlusions
| NCT ID | NCT05230446 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Erasmus Medical Center |
| Condition | Multi Vessel Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 609 participants |
| Start Date | 2021-11-18 |
| Primary Completion | 2023-11-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 609 participants in total. It began in 2021-11-18 with a primary completion date of 2023-11-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
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.
Contact & Investigator
Roberto Diletti, MD PhD
PRINCIPAL INVESTIGATOR
Erasmus Medical Center
Frequently Asked Questions
Who can join the NCT05230446 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Multi Vessel Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05230446 currently recruiting?
Yes, NCT05230446 is actively recruiting participants. Contact the research team at r.diletti@erasmusmc.nl for enrollment information.
Where is the NCT05230446 trial being conducted?
This trial is being conducted at Rotterdam, Netherlands.
Who is sponsoring the NCT05230446 clinical trial?
NCT05230446 is sponsored by Erasmus Medical Center. The principal investigator is Roberto Diletti, MD PhD at Erasmus Medical Center. The trial plans to enroll 609 participants.