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NCT01743872 · ClinicalTrials.gov registry record · NA
Optical Imaging Measurement of Intravascular Solution Efficacy Trial
A NA study of Peripheral Artery Disease, sponsored by University Hospitals Cleveland Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 23
- Enrollment target
- 1
- Study location
NCT01743872: Completed NA study of Peripheral Artery Disease, sponsored by University Hospitals Cleveland Medical Center.
NCT01743872 is a NA study of Peripheral Artery Disease that has completed, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 23 participants, below the 126-participant average among 50 other Peripheral Artery Disease trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01743872, a NA study of Peripheral Artery Disease, has completed, sponsored by University Hospitals Cleveland Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 23 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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 se
Conditions Studied
Interventions
- PROCEDURE Contrast Injection
- PROCEDURE Dextran Injection
- PROCEDURE CO2 Injection
- PROCEDURE Heparinized Normal Saline Injection
Study Locations (1)
Ohio
- University Hospitals Case Medical Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2012-09 |
| Est. Completion | 2016-06 |
| Phase | NA |
What the finished NCT01743872 record still lists
NCT01743872 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 126-participant average among 50 other Peripheral Artery Disease trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Peripheral Artery Disease appearing as the primary indexed condition, and to 4 interventions - of which Contrast Injection is the first listed.
NCT01743872 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT01743872 about?
NCT01743872 is a clinical study titled "Optical Imaging Measurement of Intravascular Solution Efficacy Trial". 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 deb...
What is the current status of trial NCT01743872?
This trial is currently completed. It is a NA study. The enrollment target is 23 participants. The study started on 2012-09. Estimated completion is 2016-06.
What conditions does trial NCT01743872 study?
This clinical trial studies the following conditions: Peripheral Artery Disease.
What interventions are being tested in trial NCT01743872?
The interventions under investigation include: Contrast Injection (PROCEDURE), Dextran Injection (PROCEDURE), CO2 Injection (PROCEDURE), Heparinized Normal Saline Injection (PROCEDURE).
Who is sponsoring clinical trial NCT01743872?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01743872 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT01743872's enrollment target sits among peer trials
23 40th of 50 higher than 11 of 50 other Peripheral Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Peripheral Artery Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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