To understand the routine use of fractional flow reserve procedure in patients with coronary artery disease.
Phase 4
Completed
- Conditions
- Health Condition 1: null- Patient is presenting with STEMI, NSTEMI, unstable angina, or stable coronary artery disease
- Registration Number
- CTRI/2018/04/013104
- Lead Sponsor
- ST JUDE MEDICAL India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 97
Inclusion Criteria
To participate in this clinical investigation, the subject must meet all
of the following inclusion criteria:
1.Patient is presenting with STEMI, NSTEMI, unstable angina, or stable coronary artery disease
2.Patient is planned to have FFR performed or underwent a cardiac catheterization where FFR was performed for further PCI consideration
3.Patient signs and dates written informed consent
4.Patient is eighteen years of age or older at the time of consent
Exclusion Criteria
To participate in this clinical investigation, the subject must meet
none of the following exclusion criteria:
1.Patient has extremely tortuous or calcified coronary arteries
2.Patient with a patent coronary artery bypass graft to the target vessel
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method