CTRI/2018/04/013104
Completed
Phase 4
Practical Evaluation of Fractional Flow Reserve (FFR) and its Associated Alternate Indices During Routine Clinical Procedures- PRESSUREwire - PRESSUREwire
ST JUDE MEDICAL India Pvt Ltd0 sites97 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Patient is presenting with STEMI, NSTEMI, unstable angina, or stable coronary artery disease
- Sponsor
- ST JUDE MEDICAL India Pvt Ltd
- Enrollment
- 97
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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