Vascular Access ComplicationsNCT02026180
Micropuncture vs. Standard Common Femoral Artery Access
A study testing Micropuncture Access in people with Vascular Access Complications, run by North Texas Veterans Healthcare System at 1 site in United States.
Trial summary
Vascular access complications can occur during or after cardiac or peripheral arterial catheterization. These complications increase patient morbidity and mortality, as well as healthcare costs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Access Complications
- What is being tested?
- Micropuncture Access
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 552 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Jun 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Arterial access obtained through the radial or brachial artery
- Age less than 18 years
- Patients with known bleeding diathesis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Comparison of Micropuncture vs. Standard Common Femoral Artery Access for Reducing Vascular Access Complications
Vascular access complications can occur during or after cardiac or peripheral arterial catheterization. These complications increase patient morbidity and mortality, as well as healthcare costs. Several strategies and devices have been employed to decrease the risk for vascular access complications, such as fluoroscopy-guided access, ultrasound-guided access and vascular closure devices. Randomized trial data has failed to demonstrate that fluoroscopic guidance reduces common femoral artery access complications. While meta-analysis data has demonstrated that vascular closure devices decrease time to arterial hemostasis, increase patient mobilization and facilitate earlier patient discharge, they do not reduce the incidence of vascular complications as compared to hemostasis achieved with manual pressure. Ultrasound guidance has been shown to facilitate femoral artery access and reduce femoral artery vascular complications. A new device, the Micropuncture Kit (Cook Medical, Bloomington, IN) allows vascular access with a small 21gauge needle as opposed to the standard method, which requires an 18 gauge needle. The use of the Micropuncture Kit for the purpose of decreasing vascular access complications has not been examined in a randomized study to date.
The present study is a 552 patient randomized controlled clinical trial that will help determine whether femoral arterial access obtained using the Micropuncture Kit will reduce the incidence of vascular access complications compared to the standard 18 gauge needle.
Read more
The specific aim of this proposal is to compare the rate of femoral artery access complications using the Micropuncture Kit vs. standard femoral artery access.
It is our hypothesis that the incidence of femoral artery access complications will be lower among patients in whom the Micropuncture Kit is used.
- Conditions
- Vascular Access Complications
- Being tested
- Micropuncture Access
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micropuncture AccessDevice
Femoral arterial access will be obtained either with a 21G micropuncture needle kit or an 18G standard access needle.
| Study group | Role | What they receive |
|---|---|---|
| Micropuncture Access | Active comparator | Vascular access using micropuncture needle kit Receives: Device: Micropuncture Access |
| Standard 18G vascular access needle | Active comparator | Vascular access using standard 18G needle Receives: Device: Micropuncture Access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial perforation
Measured: 30 days
Acute limb ischemia
Acute limb ischemia, indicated by thrombosis or loss of distal pulses
Measured: 30 days
Arteriovenous fistula
Arteriovenous fistula, defined as an abnormal communication between an artery and a vein
Measured: 30 days
Access site pseudoaneurysm
Measured: 30 days
Retroperitoneal bleeding
Retroperitoneal bleeding defined as computerized tomography confirmation of femoral artery hemorrhage into the retroperitoneal space
Measured: 30 days
Groin hematoma
Groin hematoma, defined as hematoma >5 cm.
Measured: 30 days
Femoral artery dissection
Femoral artery dissection confirmed by angiography
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionJun 2014
Why it stopped: low incidence of primary endpoint
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Access ComplicationsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 552 participants (estimated)
Sponsor and investigators
- Lead sponsor
- North Texas Veterans Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Emmanouil Brilakis, North Texas Veterans Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02026180
- Sponsor's protocol ID
- 13-090
- Status last verified
- Jul 2014
- First submitted
- 31 Dec 2013
- Last updated
- 15 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Micropuncture vs. Standard Common Femoral Artery Access for Reducing Vascular Access Complications
- ClinicalTrials.gov ID
- NCT02026180
- Acronym / sponsor ID
- 13-090
- Conditions
- Vascular Access Complications
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low incidence of primary endpoint
- Enrolment
- 552 participants (estimated)
- Lead sponsor
- North Texas Veterans Healthcare SystemUS federal agency
- Study start
- Dec 2013
- Primary completion
- Jun 2014 (actual)
- First posted
- 1 Jan 2014 (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.
Vascular access complications can occur during or after cardiac or peripheral arterial catheterization. These complications increase patient morbidity and mortality, as well as healthcare costs. Several strategies and devices have been employed to decrease the risk for vascular access complications, such as fluoroscopy-guided access, ultrasound-guided access and vascular closure devices. Randomized trial data has failed to demonstrate that fluoroscopic guidance reduces common femoral artery access complications. While meta-analysis data has demonstrated that vascular closure devices decrease time to arterial hemostasis, increase patient mobilization and facilitate earlier patient discharge, they do not reduce the incidence of vascular complications as compared to hemostasis achieved with manual pressure. Ultrasound guidance has been shown to facilitate femoral artery access and reduce femoral artery vascular complications. A new device, the Micropuncture Kit (Cook Medical, Bloomington, IN) allows vascular access with a small 21gauge needle as opposed to the standard method, which requires an 18 gauge needle. The use of the Micropuncture Kit for the purpose of decreasing vascular access complications has not been examined in a randomized study to date.
The present study is a 552 patient randomized controlled clinical trial that will help determine whether femoral arterial access obtained using the Micropuncture Kit will reduce the incidence of vascular access complications compared to the standard 18 gauge needle.
The specific aim of this proposal is to compare the rate of femoral artery access complications using the Micropuncture Kit vs. standard femoral artery access.
It is our hypothesis that the incidence of femoral artery access complications will be lower among patients in whom the Micropuncture Kit is used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Micropuncture Access | Active comparator | Device: Micropuncture AccessVascular access using micropuncture needle kit |
| Standard 18G vascular access needle | Active comparator | Device: Micropuncture AccessVascular access using standard 18G needle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Arterial access obtained through the radial or brachial artery
- Age less than 18 years
- Patients with known bleeding diathesis
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 |
|---|---|---|
| Micropuncture AccessFemoral arterial access will be obtained either with a 21G micropuncture needle kit or an 18G standard access needle. | Device | Micropuncture Access, Standard 18G vascular access needle |
Primary outcome
Arterial perforation
Time frame: 30 days
Acute limb ischemia
Time frame: 30 days
Acute limb ischemia, indicated by thrombosis or loss of distal pulses
Arteriovenous fistula
Time frame: 30 days
Arteriovenous fistula, defined as an abnormal communication between an artery and a vein
Access site pseudoaneurysm
Time frame: 30 days
Retroperitoneal bleeding
Time frame: 30 days
Retroperitoneal bleeding defined as computerized tomography confirmation of femoral artery hemorrhage into the retroperitoneal space
Groin hematoma
Time frame: 30 days
Groin hematoma, defined as hematoma >5 cm.
Femoral artery dissection
Time frame: 30 days
Femoral artery dissection confirmed by angiography
Results and safety
The study was stopped early (reason given: low incidence of primary endpoint). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micropuncture Access in people with Vascular Access Complications, run by North Texas Veterans Healthcare System 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 0 inclusion and 3 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: stopped early, as of the sponsor's last update on 15 Jul 2014. 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 was stopped early (reason given: low incidence of primary endpoint). Results are not available in the source record.
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?
Arterial perforation (time frame: 30 days). The study lists 7 primary outcomes in all. 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 15 Jul 2014.