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Arterial Closure Devices for Post-Heart Procedure Care

N/A

Waitlist Available

Led By Asim Cheema, MD

Research Sponsored by Unity Health Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients undergoing non emergent PCI procedures with a 6F arterial sheath

Femoral artery anatomy favorable for the placement of an arterial closure device

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is comparing two devices used to close an artery after a heart procedure. The study will help identify which device is better to improve patient comfort after the procedure.

Who is the study for?

This trial is for patients having a non-emergency procedure to open blocked coronary arteries (PCI) with a specific tube size through the groin. They must have suitable femoral artery anatomy for an arterial closure device and no recent use of such devices, emergency heart procedures, severe kidney disease, or symptomatic blood vessel issues.Check my eligibility

What is being tested?

The ACDC Trial II aims to determine which arterial closure device is better following PCI: 'Angioseal' or 'Starclose'. These devices are used to stop bleeding after the sheath removal from the artery. The study will assess patient comfort and outcomes with each device.See study design

What are the potential side effects?

Potential side effects may include discomfort at the site where the device is placed, bleeding complications, bruising, infection risk at the puncture site, and rare cases of damage to surrounding blood vessels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am having a planned heart procedure with a small tube in my artery.

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My femoral artery is suitable for a special closure device after a procedure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

30 day incidence of death, MI, TVR

Lack of ambulation per protocol

Minor vascular complication (minor bleeding, analgesic use)

+6 more

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Unity Health TorontoLead Sponsor

539 Previous Clinical Trials

447,317 Total Patients Enrolled

Asim Cheema, MDPrincipal InvestigatorUnity Health Toronto

3 Previous Clinical Trials

3,820 Total Patients Enrolled

Media Library

Treatment Clinical Trial Eligibility Overview. Trial Name: NCT00428155 — N/A

Coronary Artery Intervention Research Study Groups:

Coronary Artery Intervention Clinical Trial 2023: Treatment Highlights & Side Effects. Trial Name: NCT00428155 — N/A

Treatment 2023 Treatment Timeline for Medical Study. Trial Name: NCT00428155 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment still accepting test participants?

"It is evident from clinicaltrials.gov that this medical trial has ceased recruiting participants - the original posting date being January 1st 2007, with a last update on 26th of the same month. However, there are still other trials open for enrollment at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Arterial Closure Device Comparison Trial II - ACDC Trial II

2007. "Arterial Closure Device Comparison Trial II - ACDC Trial II". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00428155.