Enrollment goals were not able to be met
Understanding the Mechanism of Peripheral Arterial Balloon Angioplasty by the Chocolate PTA Balloon Catheter Compared to Conventional PTA Balloons Via OCT Imaging
Sponsor study identifier
interventional
0
1 country
2
Study Start
September 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The purpose of this study is to compare the Chocolate PTA Balloon to standard Percutaneous Transluminal Angioplasty (PTA) catheters. The investigators will use Optical Coherence Tomography (OCT) and Quantitative Vascular Angiography to evaluate the acute vascular response of vessels treated with the Chocolate Balloon to a standard balloon catheter, with the primary endpoint being luminal gain assessed by OCT lumen volume measurements.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2014
Date type not reportedThis date has not been verified as actual or estimated.
September 3, 2014
Actual (reported)September 11, 2014
Actual (reported)March 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Luminal Gain
Luminal Gain as defined by OCT lumen volume measurements. Luminal gain is assessed as the percentage change comparing pre-treatment and post-treatment volume measurements in cubic centimeters (CC) or millimeters (m3).
Average of 90 minutes
Dissection
Average of 90 minutes
Hematoma
Average of 90 minutes
Optimal PTA
Average of 90 minutes
Chocolate PTA Balloon Angioplasty
Standard PTA Balloon Angioplasty
OCT imaging of diseased vessel is treated with an Angioplasty Procedure using the Chocolate PTA Balloon Catheter followed by OCT imaging of the treated area immediately after balloon use and 10 minutes later
OCT imaging of diseased vessel is treated with an Angioplasty Procedure using a standard PTA Balloon Catheter followed by OCT imaging of the treated area immediately after balloon use and 10 minutes later
Case Medical Center
Cleveland, Ohio, 44106, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Sahil A Parikh, MD
Harrington Heart and Vascular Institute University Hospitals Case Medical Center
0 participants (actual enrollment reported by the registry).
First Submitted
September 3, 2014
First Posted
September 11, 2014
Study Start
September 2014
Date type not reportedThis date has not been verified as actual or estimated.
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Primary Completion
March 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 19, 2015
Record last verified: 2015-03
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Source: ClinicalTrials.gov.
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