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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 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.

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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.

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

FieldValue
Enrollment Target 23 participants
Start Date 2012-09
Est. Completion 2016-06
Phase NA

What the Registry Record Tells You About NCT01743872

The ClinicalTrials.gov registry entry for NCT01743872 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 126-participant average among 50 other Peripheral Artery Disease trials with a reported enrollment target (82% lower). The listed sponsor is University Hospitals Cleveland Medical Center, which has 230 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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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