Ignite Creation Date:
2024-05-06 @ 9:30 AM
Last Modification Date:
2024-10-26 @ 12:15 PM
Study NCT ID:
NCT02996877
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-24
First Post:
2016-12-15
Brief Title:
Outcomes of Surgically Ineligible Patients With Multivessel CAD
Sponsor:
Saint Lukes Health System
Organization:
Saint Lukes Health System
Study Overview
Official Title:
Outcomes of Percutaneous Revascularization for Management of Surgically Ineligible Patients With Multivessel or Left Main Coronary Artery Disease A Prospective Registry
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-11
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:
OPTIMUM
Brief Summary:
The OPTIMUM registry is a minimal risk observational study that uses a prospective cohort design to follow patients who have multivessel or left main coronary artery disease surgical anatomy according to ACCAHA Appropriateness Criteria for PCI12 and are deemed ineligible for coronary artery bypass surgery It is anticipated that 20 sites will be selected to participate in the registry from a national network of leading centers across the United States with recognized expertise in both complex PCI and coronary artery bypass surgery We will invite leading cardiac centers as defined by US News and World reports rankings for heart care Additional sites may be added to meet the target enrollment goal
Detailed Description:
Objectives 1 Compare 30-day mortality and the composite of mortality and morbidity following high-risk percutaneous coronary revascularization with predicted Society of Thoracic Surgeons STS survival and morbidity in patients with severe multivessel or left main coronary artery disease CAD
2 Compare the 12-month health status and clinical outcomes of surgically ineligible multivessel or left main CAD patients treated with PCI compared to those treated with a medical therapy alone
3 Understand the association between completeness of revascularization and long-term health status and clinical outcomes among patients with multivessel or left main CAD treated with PCI deemed ineligible for surgery
4 Compare 6-month and 1-year survival among surgically ineligible high-risk PCI patients with predicted STS survival ASCERT risk model
5 Determine the justification for surgical ineligibility by cardiologists and cardiac surgeons among patients with severe multivessel or left main coronary artery disease CAD
6 Describe the frequency and predictors of PCI versus medical management among surgically ineligible patients with severe multivessel or left main CAD
7 Describe the frequency and predictors of complete revascularization in this population
8 Describe the costs and costs per quality adjusted life year QALY gained of the strategy of management of multivessel or left main CAD with PCI versus medical therapy among surgically ineligible patients
2 Compare the 12-month health status and clinical outcomes of surgically ineligible multivessel or left main CAD patients treated with PCI compared to those treated with a medical therapy alone
3 Understand the association between completeness of revascularization and long-term health status and clinical outcomes among patients with multivessel or left main CAD treated with PCI deemed ineligible for surgery
4 Compare 6-month and 1-year survival among surgically ineligible high-risk PCI patients with predicted STS survival ASCERT risk model
5 Determine the justification for surgical ineligibility by cardiologists and cardiac surgeons among patients with severe multivessel or left main coronary artery disease CAD
6 Describe the frequency and predictors of PCI versus medical management among surgically ineligible patients with severe multivessel or left main CAD
7 Describe the frequency and predictors of complete revascularization in this population
8 Describe the costs and costs per quality adjusted life year QALY gained of the strategy of management of multivessel or left main CAD with PCI versus medical therapy among surgically ineligible patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None