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

NCT ID: NCT05230446

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 609 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-18
• Study Completion Date: 2027-11-18

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

Conditions

Multi Vessel Coronary Artery Disease; Non-ST Elevation Myocardial Infarction; Unstable Angina; Stable Angina; Coronary Artery Disease; Percutaneous Coronary Intervention; Optical Coherence Tomography

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Percutaneous Coronary Intervention

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

Group Type: OTHER

PCI with OCT guidance

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Roberto Diletti

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roberto Diletti, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

Erasmus Medical Center

Rotterdam, South Holland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Roberto Diletti, MD PhD

Role: CONTACT

r.diletti@erasmusmc.nl

+31 (0)10 70 352 60

Hala Kakar, MD

Role: CONTACT

h.kakar.1@erasmusmc.nl

Facility Contacts

Roberto Diletti, MD, PhD

Role: primary

r.diletti@erasmusmc.nl

0031634767375

Other Identifiers

NL76556.078.21

Identifier Type: -

Identifier Source: org_study_id