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

Sponsor

Erasmus Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05230446

Collaborator

(none)

609

Enrollment

Location

Arm

Anticipated Duration (Months)

8.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Multi Vessel Coronary Artery Disease Non-ST Elevation Myocardial Infarction Unstable Angina Stable Angina Coronary Artery Disease Percutaneous Coronary Intervention Optical Coherence Tomography	Device: PCI with OCT guidance	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

609 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 18, 2021

Anticipated Primary Completion Date :

Nov 18, 2023

Anticipated Study Completion Date :

Nov 18, 2027

Arms and Interventions

Arm	Intervention/Treatment
Other: Percutaneous Coronary Intervention Interventional comparitor, compared to an optimal performance goal of 7% MACCE resulted from past CABG results	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.

Arm

Intervention/Treatment

Other: Percutaneous Coronary Intervention

Interventional comparitor, compared to an optimal performance goal of 7% MACCE resulted from past CABG results

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.

Outcome Measures

Primary Outcome Measures

MACCE- 1 year [1 year]
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 Outcome Measures

MACCE [30 days, 2, and 5 years post intervention]
Composite of death from any cause, stroke, myocardial infarction, or repeat revascularization
All-cause mortality [30 days, 1, 2, and 5 years]
All-cause mortality
Myocardial Infarction [30 days, 1, 2, and 5 years]
Myocardial Infarction
Any revascularization [30 days, 1, 2, and 5 years]
Any revascularization
Stroke [30 days, 1, 2, and 5 years]
Stroke
Major bleeding [30 days and 12 months]
Major bleeding according to the ARC criteria
Renal replacement therapy [30 days]
Need for renal replacement therapy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.
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.