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

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 Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Stable Angina; Percutaneous Coronary Intervention; Unstable Angina; Multi Vessel Coronary Artery Disease; Non-ST Elevation Myocardial Infarction; Optical Coherence Tomography
• Intervention / Treatment: Device: PCI with OCT 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 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 Type: Interventional
• Enrollment (Anticipated): 609
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Roberto Diletti, MD PhD; Phone Number: +31 (0)10 70 352 60; Email: r.diletti@erasmusmc.nl
• Study Contact Backup: Name: Hala Kakar, MD; Email: h.kakar.1@erasmusmc.nl

Study Locations

• Netherlands
  • Zuid Holland
    • Rotterdam, Zuid Holland, Netherlands, 3015 GD
      • Recruiting
      • Erasmus Medical Center
      • Contact: Roberto Diletti, MD, PhD; Phone Number: 0031634767375; Email: r.diletti@erasmusmc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACCE- 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.	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Investigators: Principal Investigator: Roberto Diletti, MD PhD, Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2021
• Primary Completion (Anticipated): November 18, 2023
• Study Completion (Anticipated): November 18, 2027

Study Registration Dates

• First Submitted: November 23, 2021
• First Submitted That Met QC Criteria: January 25, 2022
• First Posted (Actual): February 9, 2022

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: January 25, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Chest Pain; Myocardial Infarction; Infarction; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Angina Pectoris; Angina, Stable; Angina, Unstable; Non-ST Elevated Myocardial Infarction
• Other Study ID Numbers: NL76556.078.21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No