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To understand the routine use of fractional flow reserve procedure in patients with coronary artery disease.

Practical Evaluation of Fractional Flow Reserve (FFR) and its Associated Alternate Indices During Routine Clinical Procedures- PRESSUREwire - PRESSUREwire

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/04/013104
Enrollment
2000
Registered
2018-04-09
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Patient is presenting with STEMI, NSTEMI, unstable angina, or stable coronary artery disease

Interventions

Intervention1: FFR: FFR-guided PCI as per the routine practice Control Intervention1: Nil: Nil Control Intervention2: Not applicable: Not applicable

Sponsors

ST JUDE MEDICAL India Pvt Ltd
Lead Sponsor

Eligibility

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
The purpose of this study is to understand routine use of FFR and alternate indices in clinical practiceTimepoint: 12 month clinical outcomes (MACE)

Secondary

MeasureTime frame
NilTimepoint: Nil

Countries

Australia, Austria, Bangladesh, Canada, Denmark, Egypt, Estonia, Germany, Greece, India, Italy, Japan, Netherlands, Norway, Portugal, Saudi Arabia, Spain, United Kingdom, United States of America

Contacts

Public ContactSumit Anand PhD

St. Jude Medical Pvt. Ltd

sanand@sjm.com01142600161

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026