Clinical trial NCT05230446: PRospective Evaluation of Complete Revascularization in Patients With multiveSsel Disease Excluding chroNic Total Occlusions
Official title: PRospective Evaluation of Complete Revascularization in Patients With multiveSsel Disease Excluding chroNic Total Occlusions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multi Vessel Coronary Artery Disease
Non-ST Elevation Myocardial Infarction
Unstable Angina
Stable Angina
Coronary Artery Disease
Percutaneous Coronary Intervention
Optical Coherence Tomography
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2022-02-09
Enrollment: 609
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 (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).

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 1-year follow-up. All patients with multivessel disease without chronic total occlusion (CTO) and accepted for PCI are eligible for inclusion

Primary endpoint The primary clinical endpoint of this study is a composite of death from any cause, stroke, myocardial infarction, or unplanned ischemia driven repeat revascularization at 1-year post index procedure.

Secondary endpoint

* Composite of death from any cause, stroke, myocardial infarction, or repeat revascularization at 30 days, 2, and 5 years post intervention.
* All-cause mortality at 30 days, 1, 2, and 5 years
* Myocardial Infarction at 30 days, 1, 2, and 5 years
* Any revascularization at 30 days, 1, 2, and 5 years
* Stroke at 30 days, 1, 2, and 5 years
* Major bleeding at 30 days and 12 months
* Need for renal replacement therapy at 30 days

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.

Primary outcomes:
measure: MACCE- 1 year
timeFrame: 1 year
Secondary outcomes:
measure: MACCE
timeFrame: 30 days, 2, and 5 years post intervention
measure: All-cause mortality
timeFrame: 30 days, 1, 2, and 5 years
measure: Myocardial Infarction
timeFrame: 30 days, 1, 2, and 5 years
measure: Any revascularization
timeFrame: 30 days, 1, 2, and 5 years
measure: Stroke
timeFrame: 30 days, 1, 2, and 5 years
measure: Major bleeding
timeFrame: 30 days and 12 months
measure: Renal replacement therapy
timeFrame: 30 days
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: Zuid Holland
Study officials:
affiliation: Erasmus Medical Center
name: Roberto Diletti, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: