Assessing the Accuracy of the OptoWire DeuxTM in a Wire to Wire Comparison

Coronary Artery Disease Clinical Trial

— ACCURACY  

Official title:

Assessing the Accuracy of the OptoWire DeuxTM in a Wire to Wire Comparison

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03815032
• Other study ID #: 18.238
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: January 2019
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of the ACCURACY study is to assess the differences, if any, in FFR measurements made by the OptoWire Deux FFR guidewire by comparison of simultaneous data of two different OptoWire DeuxTM guidewires (group 1). In addition, the investigators will compare (group 2) the FFR measurements obtained from an OptoWire Deux FFR guidewire and compare it to the FFR measurement by a VERRATA-TM guidewire to assess coronary stenosis in the routine clinical practice.

Description:

This is a single center, prospective, non-blinded clinical investigation enrolling consecutive patients with coronary lesion candidate for FFR assessment. The study aim to assess the differences, if any, in FFR measurements made by the OptoWire Deux FFR guidewire by comparison of simultaneous data of two different OptoWire DeuxTM guidewires (group 1, n=30). In addition, The investigators will compare (group 2, n=15) the FFR measurements obtained from an OptoWire Deux FFR guidewire and compare it to the FFR measurement by a VERRATA-TM guidewire to assess coronary stenosis in the routine clinical practice. The clinical investigation will be conducted in the Centre Hospitalier de l'Université de Montréal (CHUM). No clinical follow-up is requested after the end of the procedure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 31, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Single de novo coronary lesion or in-stent restenosis lesion with an operator assessed reference diameter =2.0 mm requiring FFR measurement based on the operator's clinical judgment

Exclusion Criteria:

• Patients with ST-segment-elevation myocardial infarction (STEMI), culprit lesion of non-ST-segment-elevation myocardial infarction (NSTEMI), New York Heart Association class IV heart failure, suspected or visible thrombus, dissection or excessive calcification or tortuosity in the target vessel, or a stenosis in a bypass graft will be excluded.

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Angina, Unstable
• Atherosclerosis
• Atherosclerosis, Coronary
• Coronary Artery Disease
• Coronary Stenosis
• Myocardial Ischemia
• NSTEMI - Non-ST Segment Elevation MI

Intervention

Device:
• Drift assessment of OptoWire Deux FFR wire (1)
Simultaneous data of two different OptoWire DeuxTM guidewires (group 1) to assess a single coronary stenosis and detect any difference if any.
• Drift assessment of OptoWire Deux FFR wire (2)
Simultaneous data of one Optowire Deux TM guide wires and one VERRATA-TM FFR wire (group 2) to assess a single coronary stenosis and detect any difference if any.

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)	Opsens Medical

Country where clinical trial is conducted

Canada, 

References & Publications (2)

Fearon WF. Percutaneous coronary intervention should be guided by fractional flow reserve measurement. Circulation. 2014 May 6;129(18):1860-70. doi: 10.1161/CIRCULATIONAHA.113.004300. — View Citation

Pothineni NV, Shah NN, Rochlani Y, Nairooz R, Raina S, Leesar MA, Uretsky BF, Hakeem A. U.S. Trends in Inpatient Utilization of Fractional Flow Reserve and Percutaneous Coronary Intervention. J Am Coll Cardiol. 2016 Feb 16;67(6):732-733. doi: 10.1016/j.jacc.2015.11.042. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	delta FFR	To assess the magnitude of reading delta from wire to wire in a percutaneous coronary intervention	Day 1
Secondary	Drift recording	The rate of significant drift, defined as Pd/Pa <0.97 or >1.03	Day 1
Secondary	Delta from guidewire to guidewire	Assess the magnitude of reading delta from guidewire to guidewire prior to equalization.	Day 1
Secondary	Stents	The number of stents used.	Day 1
Secondary	Stents on FFR wire	The number of stents placed over an OptoWire DeuxTM guidewire.	Day 1
Secondary	Workhorse guidewire	Number of Workhorse guidewire used.	Day 1