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

Primary Purpose

Left Anterior Descending Coronary Artery Stenosis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OpSens Medical OptoWire
FFR
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Left Anterior Descending Coronary Artery Stenosis focused on measuring FFR OCT LAD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.
  • Provides written, informed consent and HIPAA consent to use the data in a clinical study.

Exclusion Criteria:

(General exclusion criteria)

  • Patients presented with NSTEMI with the LAD involved as the culprit lesion
  • Any ST-elevation myocardial infarction within the past 30 days.
  • Hemodynamic instability requiring vasopressor or mechanical circulatory support.
  • Prior heart transplant.
  • Known left ventricular ejection fraction ≤40%.
  • LAD supplying akinetic or severely hypokinetic territories if already known based on prior imaging.
  • Patient is enrolled in another clinical study that may impact the results of this study.
  • FFR not acquired per instructions for the OpSens Wire.
  • LAD Lesion not assessed with OCT.

(Angiographic exclusion criteria)

  • Thrombolysis in Myocardial Infarction (TIMI) grade 2 or lower at baseline angiography.
  • Target lesion involves left main (stenosis >50%).
  • Previous percutaneous coronary intervention (PCI) with stent in LAD or left main trunk.
  • Presence of chronic total occlusion in any vessel.
  • Presence of a side branch≥2.75 mm with ≥70% stenosis in the LAD.
  • Bifurcation lesion that resulted in the stent implantation of a side branch.

Sites / Locations

  • New York Presbyterian Hospital/Columbia University Medical CenterRecruiting
  • St. Francis HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Opsens Medical OptoWire

Arm Description

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

Outcomes

Primary Outcome Measures

Rate of significant drift
This is to measure efficacy as defined as FFR <0.97 or >1.03 with the pre-PCI FFR recording using the OpSens OptoWire Deux pressure wire system

Secondary Outcome Measures

Full Information

First Posted
February 19, 2019
Last Updated
February 19, 2019
Sponsor
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT03848650
Brief Title
The Drift-Reduction for Improved FFR Using Fiberoptic Technology (DRIFT) Study
Acronym
OPSENS
Official Title
The Drift-Reduction for Improved Fractional Flow Reserve (FFR) Using Fiberoptic Technology (DRIFT) Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Recruiting
Study Start Date
June 19, 2018 (Actual)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
January 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
This study is designed as a prospective, observational in nature, multi-center, single-arm, clinical registry to estimate the ischemic burden of angiographically intermediate proximal LAD stenosis in clinical practice using the OpSens Medical OptoWire Deux FFR system. Subjects with stable angina or unstable angina who are found to have an intermediate proximal LAD stenosis on coronary angiography with anatomy amenable to PCI and underwent physiological lesion assessment with the OptoWire Deux pressure wire and OCT as part of their routine procedures using standard of care techniques will be enrolled. Patients meeting enrollment criteria will be offered the opportunity to enroll in this observational registry post-procedure. All patients enrolled in this study are expected to be evaluated and treated using a standard of care technique. This study will enroll a total of 60 patients at Columbia University Medical Center and St. Francis Hospital.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Left Anterior Descending Coronary Artery Stenosis
Keywords
FFR OCT LAD

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Opsens Medical OptoWire
Arm Type
Experimental
Arm Description
Subjects who will have or recently had FFR using the Opsens Medical OptoWire Deux FFR system.
Intervention Type
Device
Intervention Name(s)
OpSens Medical OptoWire
Other Intervention Name(s)
OpSens Medical OptoWire Deux FFR System
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
FFR
Other Intervention Name(s)
Fractional Flow Reserve
Intervention Description
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).
Primary Outcome Measure Information:
Title
Rate of significant drift
Description
This is to measure efficacy as defined as FFR <0.97 or >1.03 with the pre-PCI FFR recording using the OpSens OptoWire Deux pressure wire system
Time Frame
During procedure, approximately less than an hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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. Provides written, informed consent and HIPAA consent to use the data in a clinical study. Exclusion Criteria: (General exclusion criteria) Patients presented with NSTEMI with the LAD involved as the culprit lesion Any ST-elevation myocardial infarction within the past 30 days. Hemodynamic instability requiring vasopressor or mechanical circulatory support. Prior heart transplant. Known left ventricular ejection fraction ≤40%. LAD supplying akinetic or severely hypokinetic territories if already known based on prior imaging. Patient is enrolled in another clinical study that may impact the results of this study. FFR not acquired per instructions for the OpSens Wire. LAD Lesion not assessed with OCT. (Angiographic exclusion criteria) Thrombolysis in Myocardial Infarction (TIMI) grade 2 or lower at baseline angiography. Target lesion involves left main (stenosis >50%). Previous percutaneous coronary intervention (PCI) with stent in LAD or left main trunk. Presence of chronic total occlusion in any vessel. Presence of a side branch≥2.75 mm with ≥70% stenosis in the LAD. Bifurcation lesion that resulted in the stent implantation of a side branch.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kate Dalton, MS
Phone
347-514-3366
Email
keb2114@cumc.columbia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Privitera, MS
Phone
347-271-0901
Email
lp2183@cumc.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manish Parikh, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Presbyterian Hospital/Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Privitera, MS
Email
lp2183@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Manish Parikh, MD
Facility Name
St. Francis Hospital
City
Roslyn
State/Province
New York
ZIP/Postal Code
11576
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Haag, MPA
Phone
516-562-6790
Email
Elizabeth.Haag@chsli.org
First Name & Middle Initial & Last Name & Degree
Allen Jeremias, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We do not plan to share individual participant data (IPD) with other researchers.

Learn more about this trial

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

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