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Arterial Closure Device Comparison Trial II - ACDC Trial II

NCT00428155 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 448

Last updated 2007-01-29

No results posted yet for this study

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

Interventions

DEVICE

closure device placement

Sponsors & Collaborators

  • Unity Health Toronto

    lead OTHER

Principal Investigators

  • Asim Cheema, MD · Unity Health Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00428155 on ClinicalTrials.gov