Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00428155
Status:
UNKNOWN
Last Update Posted:
2007-01-29
First Post:
2007-01-25
Brief Title:
Arterial Closure Device Comparison Trial II - ACDC Trial II
Sponsor:
Unity Health Toronto
Organization:
Unity Health Toronto
Study Overview
Official Title:
A Randomized Trial of Angioseal and Starclose for Hemostasis After PCI
Status:
UNKNOWN
Status Verified Date:
2007-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
All patients scheduled to undergo percutaneous coronary interventions will be screened for inclusion into the study Informed consent will be obtained and patients will be randomized to the placement of either Angioseal or a Starclose vascular closure device to achieve hemostasis after the PCI procedure The randomization will take place after a femoral angiogram has confirmed the suitability of the femoral artery for placement of arterial closure device All patients will be monitored for bleeding or hematoma formation for twelve hours after the procedure Patients will be ambulated at two hours after placement of the arterial closure device A complete blood count and a vascular ultrasound will be performed in all patients before discharge to assess blood loss and detect vascular complications such as hematoma arteriovenous fistula or femoral artery pseudoaneurysm A written quality of life survey will be completed before discharge and at four weeks A nursing survey will be completed by the nursing staff to determine nurse-sensitive outcomes and nurse resource utilization
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None