NCT00428155|Unknown
Arterial Closure Device Comparison Trial II - ACDC Trial II
A Randomized Trial of Angioseal and Starclose for Hemostasis After PCI
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A Randomized Trial of Angioseal and Starclose for Hemostasis After PCI
Sponsor study identifier
interventional
448
1 country
1
Study Start
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
Not reported
Date not reportedPCI (coronary angioplasty) is a procedure performed through a catheter to open up blockages in the coronary arteries using balloons and stents for the treatment of angina or myocardial infarction. The balloon catheters and stents are moved to the coronary arteries through a "sheath" (a small tube used for placing of balloon and stent catheters in the body) placed in a major artery passing through the groin. After the PCI procedure and the removal of sheath, an "arterial closure device" is commonly placed to stop bleeding and allow you to get out of bed sooner. Although the usefulness of "closure devices" has been documented before their approval by the regulatory authorities, it is unclear if one device is better compared to other commercially available devices. The purpose of the study is to compare the two approved arterial closure devices, "Angioseal" and "Starclose". This study will help us identify the better of the two devices to improve patient comfort after the procedure.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
January 25, 2007
Actual (reported)January 29, 2007
Actual (reported)A composite of major vascular complications defined as device failure, bleeding, large hematoma, local infection etc.
Time to hemostasis
Lack of ambulation per protocol
Need for additional measures to achieve hemostasis (manual pressure, femostop use, etc.)
Minor vascular complication (minor bleeding, analgesic use)
post procedural myocardial infarction
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
St. Michael's Hospital
Toronto, Ontario, M5B1W8, Canada
Asim Cheema, MD
Unity Health Toronto
First Submitted
January 25, 2007
First Posted
January 29, 2007
Study Start
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
Last Updated
January 29, 2007
Record last verified: 2007-01
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Source: ClinicalTrials.gov.
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