N/A
Completed N=23
Optical Imaging Measurement of Intravascular Solution Efficacy Trial
Source: ClinicalTrials.gov NCT01743872 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcomePrimary: Quality of Images — .702; .872; .10; .743 Clear imaging field (CIF) proportion
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quality of Images |
.702; .872; .10; .743 | — |
| SECONDARY Superficial Femoral Artery Plaque Composition by Flush Medium |
57.9; 62.1; 63.0; 61.0; 6.9; 5.5 | — |
Eligibility Criteria
Inclusion Criteria
- Age greater than or equal to 18 years
- English speaking
- Scheduled to undergo an infrainguinal angiogram and/or endovascular procedure as determined by a vascular surgery specialist
- Superficial Femoral Artery diseased segment
Exclusion Criteria
- Acute or Chronic Renal insufficiency with Cr >1.5
- Chronic obstructive pulmonary disease
- Congestive heart failure (American Heart Association C lass III or IV)
- Acute limb ischemia, defined by a significant change in symptoms (one category on the Rutherford scale within the previous 14 days)
- Concurrent oral anticoagulant therapy that cannot be safely withheld
Data sourced from ClinicalTrials.gov (NCT01743872). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.