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

Primary Purpose

Multi Vessel Coronary Artery Disease, Non-ST Elevation Myocardial Infarction, Unstable Angina

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
PCI with OCT guidance
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multi Vessel Coronary Artery Disease

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Erasmus Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Percutaneous Coronary Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

MACCE
Composite of death from any cause, stroke, myocardial infarction, or repeat revascularization
All-cause mortality
All-cause mortality
Myocardial Infarction
Myocardial Infarction
Any revascularization
Any revascularization
Stroke
Stroke
Major bleeding
Major bleeding according to the ARC criteria
Renal replacement therapy
Need for renal replacement therapy

Full Information

First Posted
November 23, 2021
Last Updated
January 25, 2022
Sponsor
Erasmus Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05230446
Brief Title
PRospective Evaluation of Complete Revascularization in Patients With multiveSsel Disease Excluding chroNic Total Occlusions
Acronym
PRESENT
Official Title
PRospective Evaluation of Complete Revascularization in Patients With multiveSsel Disease Excluding chroNic Total Occlusions
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 18, 2021 (Actual)
Primary Completion Date
November 18, 2023 (Anticipated)
Study Completion Date
November 18, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multi Vessel Coronary Artery Disease, Non-ST Elevation Myocardial Infarction, Unstable Angina, Stable Angina, Coronary Artery Disease, Percutaneous Coronary Intervention, Optical Coherence Tomography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
609 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Percutaneous Coronary Intervention
Arm Type
Other
Arm Description
Interventional comparitor, compared to an optimal performance goal of 7% MACCE resulted from past CABG results
Intervention Type
Device
Intervention Name(s)
PCI with OCT guidance
Intervention Description
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.
Primary Outcome Measure Information:
Title
MACCE- 1 year
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
MACCE
Description
Composite of death from any cause, stroke, myocardial infarction, or repeat revascularization
Time Frame
30 days, 2, and 5 years post intervention
Title
All-cause mortality
Description
All-cause mortality
Time Frame
30 days, 1, 2, and 5 years
Title
Myocardial Infarction
Description
Myocardial Infarction
Time Frame
30 days, 1, 2, and 5 years
Title
Any revascularization
Description
Any revascularization
Time Frame
30 days, 1, 2, and 5 years
Title
Stroke
Description
Stroke
Time Frame
30 days, 1, 2, and 5 years
Title
Major bleeding
Description
Major bleeding according to the ARC criteria
Time Frame
30 days and 12 months
Title
Renal replacement therapy
Description
Need for renal replacement therapy
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roberto Diletti, MD PhD
Phone
+31 (0)10 70 352 60
Email
r.diletti@erasmusmc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Hala Kakar, MD
Email
h.kakar.1@erasmusmc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Diletti, MD PhD
Organizational Affiliation
Erasmus Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erasmus Medical Center
City
Rotterdam
State/Province
Zuid Holland
ZIP/Postal Code
3015 GD
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Diletti, MD, PhD
Phone
0031634767375
Email
r.diletti@erasmusmc.nl

12. IPD Sharing Statement

Learn more about this trial

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

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