Ignite Creation Date:
2024-05-06 @ 7:48 AM
Last Modification Date:
2024-10-26 @ 11:52 AM
Study NCT ID:
NCT02601664
Status:
TERMINATED
Last Update Posted:
2016-06-29
First Post:
2015-11-06
Brief Title:
Randomized-controlled Trial of a Combined vs Conventional Percutaneous Intervention for Near-Infrared Spectroscopy Defined High-Risk Native Coronary Artery Lesions
Sponsor:
North Texas Veterans Healthcare System
Organization:
North Texas Veterans Healthcare System
Study Overview
Official Title:
Randomized-controlled Trial of a Combined vs Conventional Percutaneous Intervention for Near-Infrared Spectroscopy Defined High-Risk Native Coronary Artery Lesions
Status:
TERMINATED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to lack of eligible patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONCERTO
Brief Summary:
Design Single center single-blind randomized controlled trial of patients with high risk native coronary artery lesions defined as 2 contiguous yellow blocks on the block chemogram requiring clinically indicated percutaneous coronary intervention Patients will be randomized to either a combined intervention or conventional PCI Cardiac biomarker measurements will be performed before PCI and 18-24 hours later
Treatment Combined intervention consisting of pre-PCI intracoronary vasodilator and glycoprotein IIbIIIa inhibitor administration use of an EPD if technically feasible and complete coverage of the lipid core plaque if technically feasible
Control Conventional PCI Duration 30 days follow-up The primary trial objective is to compare the incidence and size of periprocedural MI as assessed by the peak post-PCI troponin distribution in the two study groups
The secondary endpoints are 1 Reduction in the incidence of 3x and 10x upper limit of normal increase in CK-MB 2 Reduction in the incidence of slow flowno-reflow post PCI 3 Lower incidence of major adverse cardiac events defined as the composite of death acute coronary syndrome or coronary revascularization during 30-day follow-up
Treatment Combined intervention consisting of pre-PCI intracoronary vasodilator and glycoprotein IIbIIIa inhibitor administration use of an EPD if technically feasible and complete coverage of the lipid core plaque if technically feasible
Control Conventional PCI Duration 30 days follow-up The primary trial objective is to compare the incidence and size of periprocedural MI as assessed by the peak post-PCI troponin distribution in the two study groups
The secondary endpoints are 1 Reduction in the incidence of 3x and 10x upper limit of normal increase in CK-MB 2 Reduction in the incidence of slow flowno-reflow post PCI 3 Lower incidence of major adverse cardiac events defined as the composite of death acute coronary syndrome or coronary revascularization during 30-day follow-up
Detailed Description:
None
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