Trial Outcomes & Findings for The Drift-Reduction for Improved FFR Using Fiberoptic Technology (DRIFT) Study (NCT NCT03848650)

NCT ID: NCT03848650

Last Updated: 2024-06-11

Results Overview

The rate of significant drift is defined as FFR \<0.97 or \>1.03 with the in the pre-percutaneous coronary intervention (PCI) FFR recording using the OpSens OptoWire Deux pressure wire system. FFR is calculated by measuring the ratio between pressure distal to a stenosis and pressure proximally to stenosis using specialized pressure-measuring guidewires during maximal hyperemia.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: During procedure, approximately less than an hour
• Results posted on: 2024-06-11

Participant Flow

Participant milestones

Measure	Opsens Medical OptoWire Subjects who will have or recently had Fractional Flow Reserve (FFR) using the Opsens Medical OptoWire Deux FFR system. OpSens Medical OptoWire: The OptoWire is FDA approved to measure pressure in coronary vessels during diagnostic angiography and coronary interventions. The OptoWire Deux pressure wire (OpSens Medical, Quebec, Canada) is a novel technology utilizing optical coherence technology to enhance FFR assessment of the coronaries. Fractional Flow Reserve (FFR): A guide wire-based procedure that can accurately measure blood pressure and flow through a specific part of the coronary artery. FFR is done through a standard diagnostic catheter at the time of a coronary angiogram (a.k.a. cardiac catheterization).
Overall Study STARTED	60
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Opsens Medical OptoWire n=60 Participants Subjects who will have or recently had FFR using the Opsens Medical OptoWire Deux FFR system. OpSens Medical OptoWire: The OptoWire is FDA approved to measure pressure in coronary vessels during diagnostic angiography and coronary interventions. The OptoWire Deux pressure wire (OpSens Medical, Quebec, Canada) is a novel technology utilizing optical coherence technology to enhance FFR assessment of the coronaries. FFR: A guide wire-based procedure that can accurately measure blood pressure and flow through a specific part of the coronary artery. FFR is done through a standard diagnostic catheter at the time of a coronary angiogram (a.k.a. cardiac catheterization).
Age, Continuous	65 years STANDARD_DEVIATION 8.7 • n=60 Participants
Sex: Female, Male Female	18 Participants n=60 Participants
Sex: Female, Male Male	42 Participants n=60 Participants
Region of Enrollment United States	60 participants n=60 Participants
Hypertension	45 Participants n=60 Participants

PRIMARY outcome

Timeframe: During procedure, approximately less than an hour

The rate of significant drift is defined as FFR <0.97 or >1.03 with the in the pre-percutaneous coronary intervention (PCI) FFR recording using the OpSens OptoWire Deux pressure wire system. FFR is calculated by measuring the ratio between pressure distal to a stenosis and pressure proximally to stenosis using specialized pressure-measuring guidewires during maximal hyperemia.

Outcome measures

Measure

Opsens Medical OptoWire n=60 FFR recordings Subjects who will have or recently had FFR using the Opsens Medical OptoWire Deux FFR system. OpSens Medical OptoWire: The OptoWire is FDA approved to measure pressure in coronary vessels during diagnostic angiography and coronary interventions. The OptoWire Deux pressure wire (OpSens Medical, Quebec, Canada) is a novel technology utilizing optical coherence technology to enhance FFR assessment of the coronaries. FFR: A guide wire-based procedure that can accurately measure blood pressure and flow through a specific part of the coronary artery. FFR is done through a standard diagnostic catheter at the time of a coronary angiogram (a.k.a. cardiac catheterization).

Percentage of Recordings of Significant Drift in Pre and Post-PCI

5.8 Percentage

Adverse Events

Opsens Medical OptoWire

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Manish Parikh, MD

Columbia University

Phone: 212-326-8532

Email: map2224@cumc.columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place