Optical Imaging Measurement of Intravascular Solution Efficacy Trial

NACompletedINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

September 30, 2012

Primary Completion Date

December 31, 2015

Study Completion Date

June 30, 2016

Conditions
Peripheral Artery Disease
Interventions
PROCEDURE

Contrast Injection

Media #1: IV Contrast (Omnipaque 350) will be continuously injected at a rate range of 2.5-6ml/s for a maximum of 5 seconds. (Volume range of 12.5- 30ml) Intervention protocol will be followed per Cross-Reference Intervention.

PROCEDURE

Dextran Injection

Media #2: Dextran 40 Solution will be continuously injected at a rate range of 2.5-6ml/s for a maximum of 5 seconds. (Volume range of 12.5- 30ml. Intervention protocol will be followed per Cross-Reference Intervention.

PROCEDURE

CO2 Injection

Media #3: Carbon Dioxide (CO2) will be injected with large volume hand injection syringe as per the usual protocol. This be done with particular attention to avoid air in the closed system. In addition to supine, there is also an option that the patient's distal limb may be elevated to improve the flow of CO2 during injection. The surgeon will also wait at least 2 minutes between each CO2 injection to allow any potentially trapped CO2 to dissolve. A range of 20-60 ml will be used with each hand injection based on the data from the initial 5-10 pilot patients. Intervention protocol will be followed per Cross-Reference Intervention.

PROCEDURE

Heparinized Normal Saline Injection

Media #4: Heparinized Normal Saline (Heparin NS) will be hand injected using 20 mL (2 U/mL) in antegrade fashion.

Trial Locations (1)

44106

University Hospitals Case Medical Center, Cleveland

All Listed Sponsors
lead

University Hospitals Cleveland Medical Center

OTHER

NCT01743872 - Optical Imaging Measurement of Intravascular Solution Efficacy Trial | Biotech Hunter | Biotech Hunter