Ignite Creation Date:
2024-05-06 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 2:24 PM
Study NCT ID:
NCT05230446
Status:
RECRUITING
Last Update Posted:
2022-02-09
First Post:
2021-11-23
Brief Title:
PRospective Evaluation of Complete Revascularization in Patients With multiveSsel Disease Excluding chroNic Total Occlusions
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
PRospective Evaluation of Complete Revascularization in Patients With multiveSsel Disease Excluding chroNic Total Occlusions
Status:
RECRUITING
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRESENT
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None