Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT05230446

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

Sponsor: Erasmus Medical Center

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

609

Start Date

2021-11-18

Completion Date

2027-11-18

Last Updated

2022-02-09

Healthy Volunteers

Conditions

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

Interventions

DEVICE

PCI with OCT guidance

Procedure will be optimize using pre-and post-stent OCT imaging, to improve the accuracy of stent placement and reduce geographic miss, but also to prevent malapposition of the stent and to discover dissections.

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.

Locations (1)

Erasmus Medical Center

Rotterdam, South Holland, Netherlands