Coronary AngioplastyNCT00264264
Arterial Closure vs Direct Compression for Hemostasis After PCI - The ACDC Trial
A study testing Closure Device and Direct Compression in people with Coronary Angioplasty and Coronary Artery Disease, run by Unity Health Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Angioplasty, Coronary Artery Disease
- What is being tested?
- Closure Device and Direct Compression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 572 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2006to Nov 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Angioplasty, Coronary Artery Disease
- Being tested
- Closure Device, Direct Compression
- Keywords
- Closure device, Stenting, Percutaneous coronary intervention
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closure DeviceProcedure or surgery
Direct CompressionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Direct Compression | Active comparator | Not described Receives: Procedure: Direct Compression |
| Closure Device | Active comparator | Not described Receives: Procedure: Closure Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite of major vascular complications (device failure, bleeding, hematoma, infection, pseudoaneurysm, AV fistula and vascular repair)
Secondary outcomes (6)
Time to hemostasis
Ambulation time
Quality of life
Composite of minor vascular complication (bleeding, repeat compression, failure to ambulate per protocol),
Post procedural infarction
30 day MACE (death, MI, TVR)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2005 (estimated)
- Study startJul 2006
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary AngioplastyStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 572 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto
- Responsible party
- Sponsor
- Investigators
- Asim Cheema, MD, PhD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00264264
- Sponsor's protocol ID
- AC-101
- Status last verified
- May 2013
- First submitted
- 8 Dec 2005
- Last updated
- 16 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterial Closure vs Direct Compression for Hemostasis After Percutaneous Coronary Interventions
- ClinicalTrials.gov ID
- NCT00264264
- Acronym / sponsor ID
- AC-101
- Conditions
- Coronary Angioplasty, Coronary Artery Disease
- Keywords
- Closure device, Stenting, Percutaneous coronary intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 572 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- University of Toronto
- Study start
- Jul 2006
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 12 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct Compression | Active comparator | Procedure: Direct Compression |
| Closure Device | Active comparator | Procedure: Closure Device |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Closure Device | Procedure or surgery | Closure Device |
| Direct Compression | Procedure or surgery | Direct Compression |
Primary outcome
A composite of major vascular complications (device failure, bleeding, hematoma, infection, pseudoaneurysm, AV fistula and vascular repair)
6 secondary outcomes
Time to hemostasis
Ambulation time
Quality of life
Composite of minor vascular complication (bleeding, repeat compression, failure to ambulate per protocol),
Post procedural infarction
30 day MACE (death, MI, TVR)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asim Cheema, MD, PhD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closure Device and Direct Compression in people with Coronary Angioplasty and Coronary Artery Disease, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A composite of major vascular complications (device failure, bleeding, hematoma, infection, pseudoaneurysm, AV fistula and vascular repair). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2013.