Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-03-12 @ 10:44 AM
Study NCT ID:
NCT02592720
Status:
UNKNOWN
Last Update Posted:
2015-10-30
First Post:
2015-10-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cocktail Injection Improves Outcomes of FFR Guided PCI
Sponsor:
Xijing Hospital
Organization:
Study Overview
Official Title:
Intracoronary Cocktail Injection Improves Outcomes of Fractional Flow Reserve Guided Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrom (ACS)
Status:
UNKNOWN
Status Verified Date:
2015-10
Last Known Status:
RECRUITING
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:
CocktailII
Brief Summary:
This is a randomized, single blind, controlled study of intracoronary cocktail injection before fractional flow reserve (FFR) measurement when guiding percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS).
Detailed Description:
This is a randomized, single blind, controlled study of intracoronary cocktail injection before fractional flow reserve (FFR) measurement when guiding percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS). Patients with ACS will be randomized into the cocktail plus FFR guided group or the QCA guided group. The primary outcome of the cocktail II study is the composite of death, myocardial infarction, class IV heart failure and target vessel revascularization within 1 year. The secondary outcome of the cocktail II study include left ventricular function, quality of life, stroke or life-threatening bleeding within 1 year.
Study Oversight
Has Oversight DMC:
True
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?: