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

Launched by ERASMUS MEDICAL CENTER · Jan 25, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a procedure called complete revascularization using a method known as percutaneous coronary intervention (PCI) in patients with multivessel coronary artery disease. This condition means that multiple blood vessels in the heart are narrowed or blocked. The trial aims to see how well this treatment works when guided by advanced imaging technology called optical coherence tomography (OCT). It's open to adults aged 18 to 85 who have specific heart issues, such as stable angina (chest pain that comes and goes) or certain types of acute coronary syndrome, but not those with severe blockages or other serious conditions.

If you or a family member are interested in participating, you would need to meet certain criteria, such as being able to have a specific type of heart stent placed and agreeing to follow-up visits. Participants can expect to receive thorough care and monitoring throughout the trial. It's important to note that individuals with certain conditions, like severe blockages or recent heart surgery, are not eligible. This study is currently recruiting participants, and those who join will help us understand better ways to treat heart disease.

Gender

ALL

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.