Status:
COMPLETED
Arterial Closure vs Direct Compression for Hemostasis After PCI - The ACDC Trial
Lead Sponsor:
Unity Health Toronto
Collaborating Sponsors:
University of Toronto
Conditions:
Coronary Angioplasty
Coronary Artery Disease
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
Hemostasis at the arterial puncture site after percutaneous coronary interventions is achieved by either placement of a puncture closure device or by delaying sheath removal for hours to allow normali...
Detailed Description
Percutaneous coronary intervention (PCI) is the most common procedure performed for obstructive coronary artery disease with more than one million procedures performed annually in United States alone1...
Eligibility Criteria
Inclusion
- Patients undergoing elective PCI procedures. Femoral artery anatomy favorable for the placement of a closure device Planned use of clopidogrel and platelet glycoprotein IIb/IIIa antagonist
Exclusion
- Emergency PCI End stage renal disease Hemoglobin level \< 100g/l Fish Allergy. Known allergy to Protamine. Use of low molecular weight heparin within last 12 hours. Prior closure device use within 90 days. Symptomatic peripheral vascular disease. Femoral artery calcification on fluoroscopy. Arterial puncture of the superficial femoral artery. Double wall puncture (puncture of anterior \& posterior wall of femoral artery). Placement of intra aortic balloon pump. Placement of a femoral venous sheath. Coronary dissection, thrombus or perforation not resolved by the end of case
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
572 Patients enrolled
Trial Details
Trial ID
NCT00264264
Start Date
July 1 2006
End Date
November 1 2009
Last Update
May 16 2013
Active Locations (1)
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1
St. Michael's Hospital
Toronto, Ontario, Canada, M5B1W8