The Drift-Reduction for Improved FFR Using Fiberoptic Technology (DRIFT) Study

(OPSENS Trial)

Recruiting at1 trial location

Overseen by Manish Parikh, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Columbia University

No Placebo Group

Trial Summary

What is the purpose of this trial?

The primary objective of this study is to assess the accuracy, efficacy, and durability of the OpSens Medical OptoWire Deux pressure wire in the assessment of angiographically intermediate proximal left anterior descending coronary artery (LAD) stenoses in clinical practice.

Research Team

Manish Parikh, MD

Principal Investigator

Columbia University

Eligibility Criteria

Inclusion Criteria

Male or female subjects, >18 years of age.

Patients with stable angina, unstable angina or non-ST segment elevation myocardial infarction (if the LAD lesion is the non-culprit lesion) and in whom an intermediate proximal LAD de novo stenosis (30-80%) with TIMI flow 3 has been identified on angiography. Note: Patients with multi-vessel disease can be enrolled.

Patients have had fractional flow reserve (FFR) and optical coherence tomography (OCT) of the LAD with the OpSens FFR system as part of their routine evaluation as standard of care procedure.

Treatment Details

Interventions

• OpSens Medical OptoWire (Pressure Wire)

Participant Groups

Group I: Opsens Medical OptoWire Experimental Treatment 2 Interventions

Subjects who will have or recently had FFR using the Opsens Medical OptoWire Deux FFR system.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Dr. Katrina Armstrong

Columbia University

Chief Executive Officer

MD from Johns Hopkins University, MS in Epidemiology from Harvard School of Public Health

Dr. Katrina Armstrong

Columbia University

Chief Medical Officer

MD from Harvard Medical School