Trial Outcomes & Findings for Optical Imaging Measurement of Intravascular Solution Efficacy Trial (NCT NCT01743872)

Last Updated: 2022-09-21

Results Overview

The metric of image quality was the clear imaging field (CIF), which was defined as a cross section in which ≥270° of the vessel wall architecture was visualized. This has been used previously to quantify adequacy of clearance in OCT image comparison. Two independent observers, blinded to the flush medium used, analyzed all OCT frames in each pullback sequence. Any disagreement \>10% was resolved with a consensus re-evaluation at a later time point by the same reviewers. Each individual cross section was assigned a designation of quality or insufficient quality; thus, a quality image proportion was generated for each run by taking the mean of each observer's determinations

Recruitment status

COMPLETED

Study phase

Target enrollment

23 participants

Primary outcome timeframe

1 month

Results posted on

2022-09-21

Participant Flow

Patients were eligible for the study if they were undergoing elective diagnostic angiography for femoropopliteal occlusive disease as indicated by preoperative segmental pressure recordings in an accredited vascular laboratory.

Participant milestones

Participant milestones
Measure	iOCT Arterial access will performed by the operating surgeon. An aortic and infrainguinal angiogram using the standard method of intravenous iodinated contrast under digital subtraction fluoroscopy will be conducted in the usual manner according to the vascular surgeon. A 54 mm section of Superficial Femoral Artery will be chosen for study imaging. An intervention sheath or injection catheter will be placed just proximal to the area of interest. An 0.014" wire will be passed distal to the area of interest. The patient will then undergo OCT of this 54mm section with each of the three mediums below using a continuous flushing method through injection catheter. All OCT imaging will be collected at a rate of 25mm/sec. In the event of a subsequent procedure, OCT imaging will again be performed
Overall Study STARTED	23
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Optical Imaging Measurement of Intravascular Solution Efficacy Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	iOCT n=23 Participants Arterial access will performed by the operating surgeon. An aortic and infrainguinal angiogram using the standard method of intravenous iodinated contrast under digital subtraction fluoroscopy will be conducted in the usual manner according to the vascular surgeon. A 54 mm section of Superficial Femoral Artery will be chosen for study imaging. An intervention sheath or injection catheter will be placed just proximal to the area of interest. An 0.014" wire will be passed distal to the area of interest. The patient will then undergo OCT of this 54mm section with each of the three mediums below using a continuous flushing method through injection catheter. All OCT imaging will be collected at a rate of 25mm/sec. In the event of a subsequent procedure, OCT imaging will again be performed
Age, Continuous	68 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants
Diabetes	13 Participants n=5 Participants
Smoking History (>20 Years)	20 Participants n=5 Participants
Hyperlipidemia	18 Participants n=5 Participants
Rutherford Category 1-3	9 Participants n=5 Participants
Rutherford Category 4-5	13 Participants n=5 Participants
Pre-Intervention Serum Creatinine	1.03 mg/dL STANDARD_DEVIATION 0.25 • n=5 Participants
Heart Rate	68 beats/min STANDARD_DEVIATION 12 • n=5 Participants
Blood Pressure Systolic BP	140 mm Hg STANDARD_DEVIATION 24 • n=5 Participants
Blood Pressure Diastolic BP	70 mm Hg STANDARD_DEVIATION 11 • n=5 Participants
Lumen Diameter	3.99 mm STANDARD_DEVIATION 0.99 • n=5 Participants
Rutherford Class Unknown	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month

Outcome measures

Outcome measures
Measure	Contrast Injection n=19 Participants 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.	Dextran Injection n=19 Participants 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.	CO2 Injection n=19 Participants 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.	Heparinized Saline n=19 Participants Media #4: Heparinized Normal Saline (Heparin NS) will be hand injected using 20 mL (2 U/mL) in antegrade fashion.
Quality of Images	.702 Clear imaging field (CIF) proportion Standard Deviation .305	.872 Clear imaging field (CIF) proportion Standard Deviation .12	.10 Clear imaging field (CIF) proportion Standard Deviation .104	.743 Clear imaging field (CIF) proportion Standard Deviation .248

SECONDARY outcome

Timeframe: 1 month

Outcome measures

Outcome measures
Measure	Contrast Injection n=19 Participants 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.	Dextran Injection n=19 Participants 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.	CO2 Injection n=19 Participants 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.	Heparinized Saline n=19 Participants Media #4: Heparinized Normal Saline (Heparin NS) will be hand injected using 20 mL (2 U/mL) in antegrade fashion.
Superficial Femoral Artery Plaque Composition by Flush Medium Fibrotic, %	57.9 percentage of plaque composition	62.1 percentage of plaque composition	63.0 percentage of plaque composition	61.0 percentage of plaque composition
Superficial Femoral Artery Plaque Composition by Flush Medium Calcific, %	6.9 percentage of plaque composition	5.5 percentage of plaque composition	5.4 percentage of plaque composition	6.0 percentage of plaque composition
Superficial Femoral Artery Plaque Composition by Flush Medium Lipid, %	9.1 percentage of plaque composition	6.3 percentage of plaque composition	6.5 percentage of plaque composition	7.3 percentage of plaque composition
Superficial Femoral Artery Plaque Composition by Flush Medium Normal, %	24.4 percentage of plaque composition	25.6 percentage of plaque composition	22.9 percentage of plaque composition	24.3 percentage of plaque composition

Adverse Events

Contrast Injection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dextran Injection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CO2 Injection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Heparinized Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Vikram S. Kashyap

Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center

Phone: 216-844-1631

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place