Recruiting

ACDC

Sponsor:

Unity Health Toronto

Code:

NCT00428155

Conditions

Arterial Hemostasis After Coronary Intervention

Eligibility Criteria

Sex: All

Age: 25+

Healthy Volunteers: Not accepted

Interventions

closure device placement

Study Details

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.

Conditions

Arterial Hemostasis After Coronary Intervention

Study ID

NCT00428155

Start date

Jan, 2007

Status verified date

Jan, 2007

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

448 participants

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

closure device placement

Primary outcome measure

  • A composite of major vascular complications defined as device failure, bleeding, large hematoma, local infection etc. [ Time Frame: undefined ]

Central Contacts and Locations

Locations

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B1W8

Contacts

Asim Cheema, MD

416-864-5739cheemaa@smh.toronto.on.ca

Principal Investigator:

Asim Cheema, MD

More Information

Sponsor

Unity Health Toronto

Last update posted

Jan 29, 2007

Last verified

Jan, 2007

Keywords

  • hemostasis
  • angioplasty
  • stenting
  • closure device
  • angioseal
  • starclose

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2007-01-29.