Arterial Hemostasis After Coronary InterventionNCT00428155
Arterial Closure Device Comparison Trial II - ACDC Trial II
A study testing closure device placement in people with Arterial Hemostasis After Coronary Intervention, run by Unity Health Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Arterial Hemostasis After Coronary Intervention
- What is being tested?
- closure device placement
- Type of treatment
- Medical device
- How many people
- 448 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2007to not given
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing non emergent PCI procedures with a 6F arterial sheath.
- Femoral artery anatomy favorable for the placement of an arterial closure device.
Who cannot join
- Emergency PCI
- End stage renal disease
- Prior arterial closure device use within 90 days.
- Symptomatic peripheral vascular disease.
- Arterial puncture of the superficial femoral artery.
- Suspected double wall puncture (puncture of anterior \& posterior wall of femoral artery).
- Placement of intra aortic balloon pump.
- Placement of a femoral venous sheath.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Michael's Hospital
Toronto, Ontario, M5B1W8
Asim Cheema, MD, 416-864-5739, cheemaa@smh.toronto.on.ca
Asim Cheema, MD
About this study
Official title: A Randomized Trial of Angioseal and Starclose for Hemostasis After PCI
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.
Read the detailed description
All patients scheduled to undergo percutaneous coronary interventions will be screened for inclusion into the study. Informed consent will be obtained and patients will be randomized to the placement of either Angioseal or a Starclose vascular closure device to achieve hemostasis after the PCI procedure. The randomization will take place after a femoral angiogram has confirmed the suitability of the femoral artery for placement of arterial closure device. All patients will be monitored for bleeding or hematoma formation for twelve hours after the procedure. Patients will be ambulated at two hours after placement of the arterial closure device. A complete blood count and a vascular ultrasound will be performed in all patients before discharge to assess blood loss and detect vascular complications such as hematoma, arteriovenous fistula or femoral artery pseudoaneurysm. A written quality of life survey will be completed before discharge and at four weeks. A nursing survey will be completed by the nursing staff to determine nurse-sensitive outcomes and nurse resource utilization.
- Being tested
- closure device placement
- Keywords
- hemostasis, angioplasty, stenting, closure device, angioseal, starclose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
closure device placementDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite of major vascular complications defined as device failure, bleeding, large hematoma, local infection etc.
Secondary outcomes (9)
Time to hemostasis
Lack of ambulation per protocol
Need for additional measures to achieve hemostasis (manual pressure, femostop use, etc.)
Minor vascular complication (minor bleeding, analgesic use)
post procedural myocardial infarction
30 day incidence of death, MI, TVR
Patient discomfort
Quality of life measurements at discharge and four weeks
Nurse resource utilization at discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2007 (estimated)
- Study startJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial Hemostasis After Coronary InterventionStudies 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
- Single group
- Masking
- Single blind
- Enrolment
- 448 participants
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Investigators
- Asim Cheema, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00428155
- Sponsor's protocol ID
- SMH#06-140
- Status last verified
- Jan 2007
- First submitted
- 25 Jan 2007
- Last updated
- 29 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Angioseal and Starclose for Hemostasis After PCI
- ClinicalTrials.gov ID
- NCT00428155
- Acronym / sponsor ID
- SMH#06-140
- Keywords
- hemostasis, angioplasty, stenting, closure device, angioseal, starclose
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 448 participants
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Jan 2007
- First posted
- 29 Jan 2007 (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.
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.
Detailed description
All patients scheduled to undergo percutaneous coronary interventions will be screened for inclusion into the study. Informed consent will be obtained and patients will be randomized to the placement of either Angioseal or a Starclose vascular closure device to achieve hemostasis after the PCI procedure. The randomization will take place after a femoral angiogram has confirmed the suitability of the femoral artery for placement of arterial closure device. All patients will be monitored for bleeding or hematoma formation for twelve hours after the procedure. Patients will be ambulated at two hours after placement of the arterial closure device. A complete blood count and a vascular ultrasound will be performed in all patients before discharge to assess blood loss and detect vascular complications such as hematoma, arteriovenous fistula or femoral artery pseudoaneurysm. A written quality of life survey will be completed before discharge and at four weeks. A nursing survey will be completed by the nursing staff to determine nurse-sensitive outcomes and nurse resource utilization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing non emergent PCI procedures with a 6F arterial sheath.
- Femoral artery anatomy favorable for the placement of an arterial closure device.
Key exclusion criteria (8 listed)
- Emergency PCI
- End stage renal disease
- Prior arterial closure device use within 90 days.
- Symptomatic peripheral vascular disease.
- Arterial puncture of the superficial femoral artery.
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 placement | Device | – |
Primary outcome
A composite of major vascular complications defined as device failure, bleeding, large hematoma, local infection etc.
9 secondary outcomes
Time to hemostasis
Lack of ambulation per protocol
Need for additional measures to achieve hemostasis (manual pressure, femostop use, etc.)
Minor vascular complication (minor bleeding, analgesic use)
post procedural myocardial infarction
30 day incidence of death, MI, TVR
Patient discomfort
Quality of life measurements at discharge and four weeks
Nurse resource utilization at discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2007.
Related trials for Arterial Hemostasis After Coronary Intervention
Not yet recruitingObservational study
Evaluation of Safety, Performance and Usability of the TR Band DISTAL Device for Hemostasis Following Distal Radial Access in Coronary Procedures
Hemostasis, Distal Radial Artery Access (dTRA)
RecruitingObservational study
Preliminary Exploration of Factors Affecting Complete Hemostasis and Supine Time After Removal of Femoral Arterial Sheath in ICU Patients
Removal of Femoral Arterial Sheath in ICU Patients, Complete Hemostasis
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 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 placement in people with Arterial Hemostasis After Coronary Intervention, 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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 29 Jan 2007. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A composite of major vascular complications defined as device failure, bleeding, large hematoma, local infection etc.. 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 29 Jan 2007.