Status:
RECRUITING
PRospective Evaluation of Complete Revascularization in Patients With multiveSsel Disease Excluding chroNic Total Occlusions
Lead Sponsor:
Erasmus Medical Center
Conditions:
Multi Vessel Coronary Artery Disease
Non-ST Elevation Myocardial Infarction
Eligibility:
All Genders
18-85 years
Phase:
NA
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...
Detailed Description
The PRESENT is an investigator-initiated, prospective, multicenter, non-randomized, single arm, OPG study. The objective performance goal is based on past results of CABG namely a rate of 7% MACCE at ...
Eligibility Criteria
Inclusion
- 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
- 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.
- Left main coronary artery disease
- Patients who cannot give informed consent or have a life expectancy of less than 12 months.
- 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.
- Patients with an extreme LAD tortuosity imparing OCT catheter advancement
- 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.
- Previous coronary artery bypass grafting (CABG).
- Patient requiring additional cardiac surgery within 6 months.
- 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.
Key Trial Info
Start Date :
November 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 18 2027
Estimated Enrollment :
609 Patients enrolled
Trial Details
Trial ID
NCT05230446
Start Date
November 18 2021
End Date
November 18 2027
Last Update
February 9 2022
Active Locations (1)
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1
Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3015 GD