Opsens Optowire for Fractional Flow Reserve - The O2 Pilot Study

NCT02144090 | Completed

• 1 other identifier: O2 Pilot Study
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the usability and safety of the Opsens OptoWire and Optomonitor in measuring fractional flow reserve (FFR) in patients with coronary artery disease who are undergoing a coronary angiogram.

Conditions

Stable Angina; Unstable Angina Pectoris; Chest Pain; Ischemia

Keywords

Angiography; Angioplasty; Coronary artery disease; Diagnostic; Fractional flow reserve

Outcome Measures

Primary Outcomes (1)

• Safety and handling assessment of the Optowire

  1. Safely reach and cross a target lesion; 2. perform an FFR measurement using the Optowire and Optomonitor according to the product user guide; 3. disconnect the proximal connector on the OptoWire during the procedure, placing an interventional device (if necessary), and reconnecting the Optowire proximal connector; 4. safely remove the Optowire from the coronary artery. Dedicated questionnaires will be used for such assessment

  Patients will be followed through removal of the OptoWire from percutaneous insertion site and completion of the cardiac catheterization procedure (expected average <1hr)

Secondary Outcomes (1)

• Comparison of FFR values measured with Optowire vs. with FFR guide wire used in standard practice

  Patients will be followed through removal of the OptoWire from percutaneous insertion site and completion of the cardiac catheterization procedure (expected average <1hr)

Study Arms (1)

Fractional flow reserve

EXPERIMENTAL

Fractional flow reserve measurement

Device: Fractional flow reserve measurement

Interventions

Fractional flow reserve measurement DEVICE

Fractional flow reserve measurement

Also known as: Opsens Optowire and Optomonitor

Fractional flow reserve

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with
• Stable angina or,
• Unstable angina pectoris or,
• Atypical chest pain or no chest pain but with suspected ischemia
• At least one moderate lesion in native coronary artery thought to produce ischemia
• Operator and patient agree for procedures
• Patient (\> 18 years) has signed a written informed consent prior to procedure

You may not qualify if:

• Lesions with angiographic 'haziness' or suspected to contain thrombus
• Post-coronary artery bypass grafting
• Total occlusion
• If use of atherectomy device is indicated

Sponsors & Collaborators

• Laval University: lead
• Opsens, Inc.: collaborator
• International Chair on Interventional Cardiology and Transradial Approach: collaborator

Study Sites (1)

IUCPQ - Laval Hospital

Québec, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Angina, Stable; Angina, Unstable; Chest Pain; Ischemia; Coronary Artery Disease; Disease

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Olivier F Bertrand, MD PhD

  International Chair on Interventional Cardiology and Transradial Approach

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: May 15, 2014
• First Posted: May 21, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: July 10, 2015

Record last verified: 2015-07

Locations

CA (1)