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

Coronary Artery Disease Clinical Trial

— PRESENT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05230446
• Other study ID #: NL76556.078.21
• Status: Recruiting
• Phase: N/A
• Start date: November 18, 2021
• Est. completion date: November 18, 2027

Study information

• Verified date: January 2022
• Source: Erasmus Medical Center
• Contact: Roberto Diletti, MD PhD
• Phone: +31 (0)10 70 352 60
• Email: r.diletti[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 609
• Est. completion date: November 18, 2027
• Est. primary completion date: November 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Angina, Unstable
• Coronary Artery Disease
• Coronary Disease
• Infarction
• Multi Vessel Coronary Artery Disease
• Myocardial Infarction
• Myocardial Ischemia
• Non-ST Elevated Myocardial Infarction
• Non-ST Elevation Myocardial Infarction
• Optical Coherence Tomography
• Percutaneous Coronary Intervention
• Stable Angina
• Unstable Angina

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Erasmus Medical Center	Rotterdam	Zuid Holland

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

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