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

RecruitingNot applicableNCT05230446
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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).

Study details

Official title
PRospective Evaluation of Complete Revascularization in Patients With multiveSsel Disease Excluding chroNic Total Occlusions
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
Sponsor
Erasmus Medical Center
Start date
2021-11-18
Primary completion
2023-11-18
Sex
All
Age range
from 18 Years to 85 Years
Results posted
No results posted in this snapshot
Countries
Netherlands
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05230446