Trials / Completed
CompletedNCT01873560
Influence of FFR on the Clinical Outcome After Percutaneous Coronary Intervention
Influence of Fractional Flow Reserve (FFR) on the Clinical OutcomEs of PERcutaneouS Coronary Intervention (PCI): A ProspECTIVE, Multicenter FFR Registry
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,250 (actual)
- Sponsor
- Inje University · Academic / Other
- Sex
- All
- Age
- 20 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
Fractional flow reserve (FFR) is a physiologic index for the determination of ischemia-causing coronary stenosis as well as drug eluting stent (DES) optimization, even multiple anatomic imaging parameters have been widely used in clinical practice for the assessment of optimal stent procedure. Prognostic value of post-stent FFR (FFRpost) have been rarely evaluated in patient treated with 2nd generation DES. This multicentre, prospective registry was aimed to evaluate the influence of physiologic parameters on the clinical outcome after 2nd generation DES implantation.
Detailed description
Patients who diagnosed obstructive coronary artery disease and treated by DES with FFR examination would be enrolled, consecutively. FFR measurement would be required at the baseline and at the end of index PCI procedure. PCI procedure would be performed upon local routine. Any available 2nd generation DES could be used. Informed consent should be obtained and protocol should be approved by each collaborator's institutional review board (IRB). Web-based electronic-case record form (CRF) system will be used for collecting data. All data will be handled and analyzed by blind fashion at independent core lab. Patient will be followed-up at each collaborator's hospital at least 2 year after index procedure. Any adverse event will be reported and addressed immediately by appropriate medical treatment to protect patient.
Conditions
Timeline
- Start date
- 2013-05-01
- Primary completion
- 2016-06-01
- Completion
- 2016-12-01
- First posted
- 2013-06-10
- Last updated
- 2023-09-28
Locations
4 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT01873560. Inclusion in this directory is not an endorsement.