Trials / Unknown
UnknownNCT02592720
Cocktail Injection Improves Outcomes of FFR Guided PCI
Intracoronary Cocktail Injection Improves Outcomes of Fractional Flow Reserve Guided Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrom (ACS)
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- Sponsor
- Xijing Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | cocktail | Intracoronary cocktail injection before fractional flow reserve (FFR) measurement. Percutaneous Coronary Intervention (PCI) strategy is decided by FFR value in patients with acute coronary syndrome (ACS). |
| DEVICE | FFR | Percutaneous Coronary Intervention (PCI) strategy is decided by FFR value in patients with acute coronary syndrome (ACS). |
| DEVICE | QCA guided group | Percutaneous Coronary Intervention (PCI) strategy is decided by QCA value in patients with acute coronary syndrome (ACS). |
Timeline
- Start date
- 2015-10-01
- Primary completion
- 2017-10-01
- Completion
- 2017-10-01
- First posted
- 2015-10-30
- Last updated
- 2015-10-30
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT02592720. Inclusion in this directory is not an endorsement.