Vascular ClosureNCT00842179
Groin Complications Post Percutaneous Coronary Intervention Using Either Manual Compression or PERCLOSE Device
An observational study of Vascular Closure, run by Clinyx, LLC at 1 site in United States.
Trial summary
The objective of this study is to compare groin complication rates in low and high risk patients post percutaneous coronary intervention (PCI) closed by either a 6 French Perclose vascular closure device (VCD) or manual compression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Closure
- How many people
- 2,517 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Oct 2008
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who require vascular closure post percutaneous coronary intervention
Who may be able to join
- Patients who received vascular closure with the Perclose device post PCI at Baptist Miami Hospital
- Patients who received vascular closure by manual compression at Tampa General Hospital
Who cannot join
- Patients less than 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Femoral Access Site Groin Complication Rates After 2517 Groin Punctures Undergoing Vascular Closure by Either Manual Compression or the Perclose Vascular Closure Device
The objective of this study is to compare groin complication rates in low and high risk patients post percutaneous coronary intervention (PCI) closed by either a 6 French Perclose vascular closure device (VCD) or manual compression.
Read the detailed description
It is commonly accepted that that there exists a learning curve in performing successful groin closure with Vascular Closure Devices (VCD). Manual compression continues to be 'standard of care' at most institutions for closure of 5 - 8 French femoral arteriotomies, as previous studies evaluating the safety and efficacy of vascular closure devices have failed to show a statistically significant decrease in groin complication rates when compared to manual compression. Importantly, no studies to date have been performed to specifically assess the potential decrease in vascular complication rates by highly experienced VCD operators, when their safety results are compared to manual compression. This retrospective, multi-center study will demonstrate a lower vascular complication rate in PCI patients post deployment of a 6 Fr Perclose VCD by a single, experienced operator, when compared to manual compression in two comparable, high volume, hospital cardiac catheterization laboratories.
- Conditions
- Vascular Closure
- Keywords
- Perclose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Manual Closure | Patients who received vascular closure with manual compression after percutaneous coronary intervention (PCI) | |
| Perclose Device | Patients who received vascular closure with the Perclose VCD after percutaneous coronary intervention (PCI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
major vascular complications
Measured: 0-30 days (during Index hospitalization)
Secondary outcomes (1)
Minor vascular complications
Measured: 0-30 days (during index hospitalization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2009 (estimated)
- Study startJun 2008
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular ClosureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,517 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinyx, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Investigators
- Jonathan Roberts, MD, Principal investigator, Baptist Health South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00842179
- Sponsor's protocol ID
- CL-003
- Status last verified
- Feb 2009
- First submitted
- 6 Feb 2009
- Last updated
- 12 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femoral Access Site Groin Complication Rates After 2517 Groin Punctures Undergoing Vascular Closure by Either Manual Compression or the Perclose Vascular Closure Device
- ClinicalTrials.gov ID
- NCT00842179
- Acronym / sponsor ID
- CL-003
- Conditions
- Vascular Closure
- Keywords
- Perclose
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,517 participants (actual)
- Lead sponsor
- Clinyx, LLCUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- Jun 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 12 Feb 2009 (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.
The objective of this study is to compare groin complication rates in low and high risk patients post percutaneous coronary intervention (PCI) closed by either a 6 French Perclose vascular closure device (VCD) or manual compression.
Detailed description
It is commonly accepted that that there exists a learning curve in performing successful groin closure with Vascular Closure Devices (VCD). Manual compression continues to be 'standard of care' at most institutions for closure of 5 - 8 French femoral arteriotomies, as previous studies evaluating the safety and efficacy of vascular closure devices have failed to show a statistically significant decrease in groin complication rates when compared to manual compression. Importantly, no studies to date have been performed to specifically assess the potential decrease in vascular complication rates by highly experienced VCD operators, when their safety results are compared to manual compression. This retrospective, multi-center study will demonstrate a lower vascular complication rate in PCI patients post deployment of a 6 Fr Perclose VCD by a single, experienced operator, when compared to manual compression in two comparable, high volume, hospital cardiac catheterization laboratories.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Closure | – | –Patients who received vascular closure with manual compression after percutaneous coronary intervention (PCI) |
| Perclose Device | – | –Patients who received vascular closure with the Perclose VCD after percutaneous coronary intervention (PCI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who require vascular closure post percutaneous coronary intervention
Key inclusion criteria (2 listed)
- Patients who received vascular closure with the Perclose device post PCI at Baptist Miami Hospital
- Patients who received vascular closure by manual compression at Tampa General Hospital
Key exclusion criteria (1 listed)
- Patients less than 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
major vascular complications
Time frame: 0-30 days (during Index hospitalization)
1 secondary outcome
Minor vascular complications
Time frame: 0-30 days (during index hospitalization)
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 12 Feb 2009.
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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.
Jonathan Roberts, MD principal investigator
Baptist Health South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Closure, run by Clinyx, LLC at 1 site in United States.
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 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 12 Feb 2009. 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 United States. 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?
major vascular complications (time frame: 0-30 days (during Index hospitalization)). 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 12 Feb 2009.