PRospective Evaluation of Complete Revascularization in Patients With multiveSsel Disease Excludi… (NCT05230446) | Clinical Trial Compass
RecruitingNot Applicable
PRospective Evaluation of Complete Revascularization in Patients With multiveSsel Disease Excluding chroNic Total Occlusions
Netherlands609 participantsStarted 2021-11-18
Plain-language 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).
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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.