Arterial Closure Device Comparison Trial II – ACDC Trial II
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00428155|
Recruitment Status : Unknown
Verified January 2007 by St. Michael's Hospital, Toronto.
Recruitment status was: Recruiting
First Posted : January 29, 2007
Last Update Posted : January 29, 2007
PCI (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.
|Condition or disease||Intervention/treatment||Phase|
|Arterial Hemostasis After Coronary Intervention||Device: closure device placement||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||448 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||A Randomized Trial of Angioseal and Starclose for Hemostasis After PCI|
|Study Start Date :||January 2007|
- 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
- 30 day incidence of death, MI, TVR
- Patient discomfort
- Quality of life measurements at discharge and four weeks
- Nurse resource utilization at discharge
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00428155
|St. Michael's Hospital||Recruiting|
|Toronto, Ontario, Canada, M5B1W8|
|Contact: Asim Cheema, MD 416-864-5739 firstname.lastname@example.org|
|Principal Investigator: Asim Cheema, MD|
|Sub-Investigator: Robert Chisholm, MD|
|Principal Investigator:||Asim Cheema, MD||St. Michael's Hospital, Toronto|