Evaluation of the Opsens Fractional Flow Reserve (FFR) Wire as a "Work Horse" Wire

NCT03227588 | Unknown

• 1 other identifier: 966635
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The use of fractional flow reserve (FFR) has improved outcomes in percutaneous coronary interventions (PCI) in patients with symptomatic stable coronary artery disease (CAD) with intermediate angiographic stenoses. It is a clinical tool used routinely in cardiac catheterization laboratories throughout the world including the Little Rock VA Hospital. The technique utilizes a pressure transducer constructed as part of an 0.014" guidewire. An FFR of \>0.80 has been linked with myocardial ischemia found with nuclear stress and dobutamine echo stress testing. The FAME trial clearly demonstrated its value in improving long-term outcomes as compared to use of angiography alone. As such, the use of FFR is incorporated into both AHA ACC and European PCI guideline recommendations as part of routine care for intermediate lesions. A "work horse" guide wire is so defined because it can be used in most PCI cases. It combines a low tip load (to avoid intimal dissection, with excellent (ideally, one to one) torque transmission and trackability through tortuous lesions. Recently the FDA has approved an FFR guide wire, OptoWire, (Opsens, Quebec City, Quebec, CAN) which uses light transmission to measure pressure rather than electrical transduction wires. The primary purpose of the present study is to determine how effective this wire is as a work horse wire in patients in whom FFR is required. The OptoWire may also have the advantage of less "drift" occurring during the procedure. Drift refers to the change in pressure due to issues related to the wire and measuring system, rather than a true change in pressure. All current FFR wire systems demonstrate some degree of drift requiring measuring pressure of the wire in the aorta after the procedure is completed to determine if, and to what extent, drift has occurred. Thus, a secondary aim of this study will determine the degree of drift.

Conditions

Coronary Artery Disease

Keywords

Fractional Flow Reserve; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• Opsens FFR Wire Performance

  Satisfactory performance is defined as the ability to perform the entire PCI plus measure FFR pre and post PCI with drift \<0.05.

  Acute result at end of procedure

Secondary Outcomes (1)

• Incidence of Ischemic or Low Non-ischemic FFR post PCI requiring further intervention

  Acute result at end of procedure

Interventions

Fractional Flow Reserve DIAGNOSTIC_TEST

This is a prospective data collection study for patients that have undergone FFR.

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients (age 18-89 years old) eligible and in whom the operator has performed FFR will be included to systematically evaluate the performance of the OptoWire FFR wire. A total of 1000 consecutive patients deemed to require FFR as part of clinical care will be included. It is felt that 1000 patients represent a reasonable sample size to study the OptoWire FFR wire handling characteristics, the primary endpoint of the study.

You may qualify if:

• Patients (age 18-89 years old) eligible and in whom the operator has performed FFR will be included to systematically evaluate the performance of the OptoWire FFR wire. A total of 1000 consecutive patients deemed to require FFR as part of clinical care will be included. It is felt that 1000 patients represent a reasonable sample size to study the OptoWire FFR wire handling characteristics, the primary endpoint of the study

You may not qualify if:

• Not a candidate for FFR
• Chronic total occlusion lesion
• Hemodynamically unstable
• Saphenous vein graft lesions -

Sponsors & Collaborators

• Central Arkansas Veterans Healthcare System: lead

Study Sites (1)

John L. McClellan Memorial Veterans Hospital

Little Rock, Arkansas, 72205, United States

RECRUITING

Related Publications (5)

• Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24. doi: 10.1056/NEJMoa0807611.

  PMID: 19144937 BACKGROUND

• Costa F, Ariotti S, Valgimigli M, Kolh P, Windecker S; Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Perspectives on the 2014 ESC/EACTS Guidelines on Myocardial Revascularization : Fifty Years of Revascularization: Where Are We and Where Are We Heading? J Cardiovasc Transl Res. 2015 Jun;8(4):211-20. doi: 10.1007/s12265-015-9632-6. Epub 2015 May 19.

  PMID: 25986910 BACKGROUND

• Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, Mukherjee D, Nallamothu BK, Ting HH; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines; Society for Cardiovascular Angiography and Interventions. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. J Am Coll Cardiol. 2011 Dec 6;58(24):e44-122. doi: 10.1016/j.jacc.2011.08.007. Epub 2011 Nov 7. No abstract available.

  PMID: 22070834 BACKGROUND

• Agarwal SK, Kasula S, Hacioglu Y, Ahmed Z, Uretsky BF, Hakeem A. Utilizing Post-Intervention Fractional Flow Reserve to Optimize Acute Results and the Relationship to Long-Term Outcomes. JACC Cardiovasc Interv. 2016 May 23;9(10):1022-31. doi: 10.1016/j.jcin.2016.01.046.

  PMID: 27198682 BACKGROUND

• Uretsky BF, Agarwal SK, Vallurupalli S, Al-Hawwas M, Hasan R, Miller K, Hakeem A. Prospective Evaluation of the Strategy of Functionally Optimized Coronary Intervention. J Am Heart Assoc. 2020 Feb 4;9(3):e015073. doi: 10.1161/JAHA.119.015073. Epub 2020 Jan 30.

  PMID: 32013707 DERIVED

Related Links

• Optowire product information

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Fractional Flow Reserve, Myocardial

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Coronary Circulation; Blood Circulation; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Barry F. Uretsky, MD

  CAVHS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barry F. Uretsky, MD

CONTACT

501-257-1000; barry.uretsky@va.gov

Kristin G Miller, RN, CCRC

CONTACT

501-257-5893; kristin.miller4@va.gov

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Interventional Cardiology and Cath Lab

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: July 24, 2017
• Study Start: April 10, 2017
• Primary Completion: December 10, 2019
• Study Completion: December 10, 2019
• Last Updated: February 12, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)