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

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2018/04/013104
• Date of registration: 09-04-2018
• Prospective Registration: No
• Primary sponsor: ST JUDE MEDICAL India Pvt Ltd
• Public title: To understand the routine use of fractional flow reserve procedure in patients with coronary artery disease.
• Scientific title: Practical Evaluation of Fractional Flow Reserve (FFR) and its Associated Alternate Indices During Routine Clinical Procedures- PRESSUREwire - PRESSUREwire
• Date of first enrolment: 15-10-2017
• Target sample size: 2000
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=19582
• Study type: PMS
• Study design: Other; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
• Phase: Post Marketing Surveillance

Countries of recruitment

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

• Name: Sumit Anand PhD
• Affiliation: St. Jude Medical Pvt. Ltd

• Name: Sumit Anand PhD
• Affiliation: St. Jude Medical Pvt. Ltd

Key inclusion & exclusion 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

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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

Primary Outcome(s)

The purpose of this study is to understand routine use of FFR and alternate indices in

clinical practiceTimepoint: 12 month clinical outcomes (MACE)

Secondary Outcome(s)

NilTimepoint: Nil

Secondary ID(s)

CRD 795 Ver. B

Source(s) of Monetary Support

ST JUDE MEDICAL India Pvt Ltd

Ethics review

Status: Approved
Approval date: 13/09/2017
Contact:

Institutional Ethics Committee, MMM

Status: Approved
Approval date: 14/09/2017
Contact:

Lisie Hospital Institutional Ethics Committe, Lisie Hospital

Status: Approved
Approval date: 26/09/2017
Contact:

Institutional Ethics Committee, Sunshine Hospital

Status: Approved
Approval date: 05/10/2017
Contact:

Ethics Committee Sliver, Christian Medical College, Vellore

Status: Approved
Approval date: 13/10/2017
Contact:

Ethics Committee-Caritas Hospital

Status: Approved
Approval date: 01/11/2017
Contact:

Institutional Ethics Committee,Apollo Hospital Enterprises Ltd.

Status: Approved
Approval date: 21/11/2017
Contact:

Institutional Ethics Committee, PGIMER, Chandigarh

Status: Approved
Approval date: 08/12/2017
Contact:

Ethics Committee Ananthapuri Hospital and Research Institute

Status: Approved
Approval date: 20/12/2017
Contact:

Institutional Ethics Committee, Fortis Escorts Hospital

Status: Approved
Approval date: 20/12/2017
Contact:

Institutional Ethics Committee, Sree Chitra Triunal Institute for Medical Sciences and Technology

Status: Approved
Approval date: 18/01/2018
Contact:

Medanta Institutional Ethics Committee

Results

• Date Completed: 22/02/2018