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Arterial Closure vs Direct Compression for Hemostasis After PCI - The ACDC Trial

NCT00264264 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 572

Last updated 2013-05-16

No results posted yet for this study

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 normalization of heparin induced anticoagulation. Both of these methods are far from ideal. Delayed sheath removal poses a risk of recurrent bleeding, hematoma formation and results in decreased patient mobility while the safety of closure devices has been called into question by several recent reports. Due to the lack of definitive data, the arterial access site management varies considerably between physicians and among institutions. The proposed study will evaluate the safety and efficacy of arterial closure devices to achieve hemostasis compared with immediate sheath removal after protamine administration followed by direct compression after percutaneous coronary intervention procedures.

Conditions

Interventions

PROCEDURE

Closure Device

PROCEDURE

Direct Compression

Sponsors & Collaborators

  • University of Toronto

    collaborator OTHER

  • Unity Health Toronto

    lead OTHER

Principal Investigators

  • Asim Cheema, MD, PhD · Unity Health Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT00264264 on ClinicalTrials.gov