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

May 15, 2013 updated by: Unity Health Toronto

Arterial Closure vs Direct Compression for Hemostasis After Percutaneous Coronary Interventions

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Percutaneous coronary intervention (PCI) is the most common procedure performed for obstructive coronary artery disease with more than one million procedures performed annually in United States alone1. Despite major advances in technology and operative expertise, the optimum management of arterial access site after PCI procedures remains unclear.

The conventional practice of arterial access site management involves delaying of sheath removal for several hours to allow normalization of heparin induced anticoagulation. This delayed sheath removal poses a risk of recurrent bleeding and hematoma formation. Furthermore, delayed sheath removal results in decreased patient mobility, increased patient discomfort and requires frequent monitoring with an impact on nursing resources. The risks associated with delayed sheath removal may be further increased by concomitant administration of potent anti platelet therapy now routinely used in patients undergoing PCI2.

Arterial puncture closure devices (APCD) were developed to obtain immediate arterial access site hemostasis after closed vascular procedures with an aim towards early patient mobilization. Although the efficacy of APCD have been documented in several small studies but limited information is available regarding their safety in diverse patient populations. A recent meta analysis has shown increased vascular complication rate associated with the use of these devices bringing the safety of their routine use into question3.

Due to lack of definitive data, the arterial access site management varies considerably between physicians and among institutions. APCD are routinely used by some centers4 while others continue to delay arterial sheath removal for several hours after the procedure5.

Immediate sheath removal followed by direct compression though routinely practiced after coronary angiographic procedures is not used after PCI procedures due to the intra procedural administration of heparin resulting in prolonged anticoagulation. Reversal of heparin with protamine may allow immediate sheath removal resulting in early patient ambulation and decreased access site vascular complications. The safety and efficacy of intravenous protamine administration for reversal of heparin is well established by its routine use in cardiovascular surgery for several decades6 and recent reports showing safety and efficacy of this method for early sheath removal after PCI procedures7-9.

The proposed study is designed to evaluate the safety and efficacy of immediate sheath removal followed by direct compression as compared to the use of APCD to achieve hemostasis after PCI.

Study Type

Interventional

Enrollment (Actual)

572

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
        • St. Michael's Hospital

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients undergoing elective PCI procedures. Femoral artery anatomy favorable for the placement of a closure device Planned use of clopidogrel and platelet glycoprotein IIb/IIIa antagonist

Exclusion Criteria:

Emergency PCI End stage renal disease Hemoglobin level < 100g/l Fish Allergy. Known allergy to Protamine. Use of low molecular weight heparin within last 12 hours. Prior closure device use within 90 days. Symptomatic peripheral vascular disease. Femoral artery calcification on fluoroscopy. Arterial puncture of the superficial femoral artery. Double wall puncture (puncture of anterior & posterior wall of femoral artery). Placement of intra aortic balloon pump. Placement of a femoral venous sheath. Coronary dissection, thrombus or perforation not resolved by the end of case

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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Direct Compression
Procedure: Direct Compression
Active Comparator: Closure Device
Procedure: Closure Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
A composite of major vascular complications (device failure, bleeding, hematoma, infection, pseudoaneurysm, AV fistula and vascular repair)

Secondary Outcome Measures

Outcome Measure
Quality of life
Time to hemostasis
Ambulation time
Composite of minor vascular complication (bleeding, repeat compression, failure to ambulate per protocol),
Post procedural infarction
30 day MACE (death, MI, TVR)

Collaborators and Investigators

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

Sponsor

Unity Health Toronto

Collaborators

University of Toronto

Investigators

  • Principal Investigator: Asim Cheema, MD, PhD, 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

July 1, 2006

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

December 8, 2005

First Submitted That Met QC Criteria

December 8, 2005

First Posted (Estimate)

December 12, 2005

Study Record Updates

Last Update Posted (Estimate)

May 16, 2013

Last Update Submitted That Met QC Criteria

May 15, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC-101

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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