Arterial Closure Device Comparison Trial II – ACDC Trial II

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by St. Michael's Hospital, Toronto.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT00428155
First received: January 25, 2007
Last updated: January 26, 2007
Last verified: January 2007
  Purpose

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 Intervention
Arterial Hemostasis After Coronary Intervention
Device: closure device placement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Randomized Trial of Angioseal and Starclose for Hemostasis After PCI

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • A composite of major vascular complications defined as device failure, bleeding, large hematoma, local infection etc.

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 448
Study Start Date: January 2007
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.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing non emergent PCI procedures with a 6F arterial sheath.
  • Femoral artery anatomy favorable for the placement of an arterial closure device.

Exclusion Criteria:

  • Emergency PCI
  • End stage renal disease
  • Prior arterial closure device use within 90 days.
  • Symptomatic peripheral vascular disease.
  • Arterial puncture of the superficial femoral artery.
  • Suspected double wall puncture (puncture of anterior & posterior wall of femoral artery).
  • Placement of intra aortic balloon pump.
  • Placement of a femoral venous sheath.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00428155

Locations
Canada, Ontario
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B1W8
Contact: Asim Cheema, MD    416-864-5739    cheemaa@smh.toronto.on.ca   
Principal Investigator: Asim Cheema, MD         
Sub-Investigator: Robert Chisholm, MD         
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: Asim Cheema, MD St. Michael's Hospital, Toronto
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00428155     History of Changes
Other Study ID Numbers: SMH#06-140
Study First Received: January 25, 2007
Last Updated: January 26, 2007
Health Authority: Canada: Health Canada

Keywords provided by St. Michael's Hospital, Toronto:
hemostasis
angioplasty
stenting
closure device
angioseal
starclose

ClinicalTrials.gov processed this record on August 27, 2014