Optical Imaging Measurement of Intravascular Solution Efficacy Trial

Summary

Iodinated contrast is the current gold standard for infrainguinal angiography imaging in patients without renal insufficiency and has also been used with intravascular Optical Coherence Tomography (iOCT) to improve image quality in human coronary arteries as well as carotid arteries. The current debate in the literature for iOCT medium is between iodinated contrast and dextran and CO2 may offer a superior method of iOCT imaging during lower extremity occlusive disease interventions.

The investigators hypothesize that the CO2 medium injection during iOCT data acquisition is feasible and will produce at least the same quality of imaging as that obtained with contrast or dextran without causing the problems of volume overload and renal toxicity seen with the two latter mediums.

Primary Outcomes Measured

* Quality: Cumulative number of clear image frame (CIF) through the entire 54mm length segment.
* Quantitative: Calculations of the area and diameter of each segment will be measured to determine if index of refraction has any effect between the three mediums to be tested.

The investigators expect to find little difference between all three iOCT mediums and hope to conclude that CO2 offers a superior side effect profile for iOCT imaging in the lower extremity arterial system.

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.

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center

  lead OTHER

Principal Investigators

• Vikram S Kashyap, MD · UH Hospitals Cleveland Medical Center

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-09-30

Primary Completion

2015-12-31

Completion

2016-06-30

Countries

• United States

Study Locations