Arterial Closure Device Comparison Trial II - ACDC Trial II

January 26, 2007 updated by: Unity Health Toronto

A Randomized Trial of Angioseal and Starclose for Hemostasis After PCI

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

448

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B1W8
        • Recruiting
        • St. Michael's Hospital
        • Contact:
        • Sub-Investigator:
          • Robert Chisholm, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
A composite of major vascular complications defined as device failure, bleeding, large hematoma, local infection etc.

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Study Registration Dates

First Submitted

January 25, 2007

First Submitted That Met QC Criteria

January 26, 2007

First Posted (Estimate)

January 29, 2007

Study Record Updates

Last Update Posted (Estimate)

January 29, 2007

Last Update Submitted That Met QC Criteria

January 26, 2007

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SMH#06-140

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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