Coronary DiseaseCLOSE-UP IIINCT02237430
Randomized Comparison of MynxGrip Vascular Closure Device and Manual Compression for Closure After Femoral Access Angiography. The Closure Devices Used in Every Day Practice Study, CLOSE-UP III Trial
A study testing MynxGrip and Manual compression in people with Coronary Disease, run by Aarhus University Hospital Skejby at 1 site in Denmark.
Trial summary
Is the MynxGrip (test device) non-inferior to manuel compression (standard comparator) in the incidence of adverse access site related events in-hospital, at 30 days and at 6 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease
- What is being tested?
- MynxGrip and Manual compression
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 869 participants
- Where
- 1 siteDenmark
- Study dates
- 16 Jun 2014to 16 Dec 2018
- 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
- >18 year
- Should be able to provide valid informed signed consent
- CAG, possibly including intracoronary measurement (FFR) or intracoronary imaging (IVUS, optical coherence tomography (OCT), NIRS)
Who cannot join
- Percutaneous coronary intervention (PCI) procedure and/or implantation of stents
- ST-Elevations Myocardial Infarction (STEMI)
- Multiple punctures
- Active infection
- Groin haematoma before the closure procedure
- Known pseudoaneurysm or arteriovenous (AV) fistula in the ipsilateral groin
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- Cardiogenic shock
- Prior peripheral arterial surgery in abdomen or lower extremities
- Sheat size >7 F
- Life expectancy less than one year
- Possible pregnancy or positive pregnancy test or breastfeeding women
- Simultaneous or planned subsequent femoral vein access
- Allergy to any of the components in the closure material left in the groin
- Puncture or closure with closure device at same site < 30 days
- Puncture or closure with manuel compression at same site < 5 days
- Patients with peripheral artery disease can be included at operators discretion except if heavy calcification is present at the access site, which at the operators discretion precludes insertion of the closure device
Trial locations and contacts
1 site in 1 country.
About this study
Is the MynxGrip (test device) non-inferior to manuel compression (standard comparator) in the incidence of adverse access site related events in-hospital, at 30 days and at 6 months.
Read the detailed description
Prospective, randomized (1:1), controlled, non-blinded, single center study in 2000 patients comparing the MynxGrip (test device) and manuel compression (standard comparator). Safety and efficacy endpoints will be reported for in-hospital, 30 days and 6 months.
- Conditions
- Coronary Disease
- Being tested
- MynxGrip, Manual compression
- Keywords
- Coronary angiography (CAG)
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MynxGripDevice
Also called Closure device
Closure device for femoral artery access closure
Manual compressionOther
Conventional manual compression
| Study group | Role | What they receive |
|---|---|---|
| Manuel compression | Active comparator | Conventional manual compression Receives: Other: Manual compression |
| MynxGrip closure device | Experimental | Closure device for femoral artery access closure Receives: Device: MynxGrip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence at 30 days of the composite endpoint of serious access site related major adverse vascular events (MAVE)
This includes: Major bleeding and/or blood transfusion, pseudoaneurysm with indication for treatment, arteriovenous fistula, groin surgery of leg, definitely or possible can be related to the closure procedure, infection needing antibiotics.
Measured: 30 days
Secondary outcomes (14)
Time (min) to haemostasis
From inserting the device (MynxGrip) until haemostasis and from beginning of manual compression to immediately haemostasis
Measured: 30 days
Device failure
Measured: 30 minutes
Vasovagal reaction until 5 minutes after end of closure procedure
Measured: 30 minutes
Need for new onset of manual compression
Measured: 30 days
Pain and discomfort related to the closure procedure
Assessed on a numerical rating scale (NRS) from 0 (no pain or discomfort) to 10 (worst possible pain or discomfort).
Measured: Closure procedure and 30 days
Time to mobilization
From start of closure procedure to patient is mobilised.
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 days
In-hospital large groin haematoma
Larger than 5 x 5 cm measured by ruler in the catheterisation laboratory or at discharge
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 days
Bleedings according to the Bleeding Academic Research Consortium (BARC) definitions
Measured: 1 hour and 30 days
Major bleeding and/or bleeding necessitation blood transfusion
Measured: 30 days and 6 months
Pseudoaneurysm with indication for treatment
Measured: 30 days and 6 months
Arteriovenous fistula
Measured: 30 days and 6 months
Groin surgery and/or possible related vascular surgery
Measured: 30 days and 6 months
Infection needing antibiotics
Measured: 30 days and 6 months
Need for medical evaluation of possible closure procedure related symptom(s)
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 posted11 Sep 2014 (estimated)
- Study start16 Jun 2014
- Primary completion16 May 2017
- Study completion16 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies 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
- None (open label)
- Enrolment
- 869 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital Skejby
- Sponsor type
- University, hospital or other
- Collaborators
- Vingmed Danmark A/S
- Responsible party
- Principal investigator, Evald Hoej Christiansen, Aarhus University Hospital Skejby
- Investigators
- Evald H Christiansen, MD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02237430
- Sponsor's protocol ID
- CLOSE-UP III
- Acronym
- CLOSE-UP III
- Status last verified
- May 2019
- First submitted
- 4 Sep 2014
- Last updated
- 8 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jakobsen L, Holm NR, Maeng M, Thim T, Kristensen SD, Mogensen LH, Christiansen EH. Comparison of MynxGrip vascular closure device and manual compression for closure after femoral access angiography: a randomized controlled trial: the closure devices used in every day practice study, CLOSE-UP III trial. BMC Cardiovasc Disord. 2022 Feb 23;22(1):68. doi: 10.1186/s12872-022-02512-0.
PubMed 35196986
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of MynxGrip Vascular Closure Device and Manual Compression for Closure After Femoral Access Angiography. The Closure Devices Used in Every Day Practice Study, CLOSE-UP III Trial
- ClinicalTrials.gov ID
- NCT02237430
- Acronym / sponsor ID
- CLOSE-UP III / CLOSE-UP III
- Conditions
- Coronary Disease
- Keywords
- Coronary angiography (CAG)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 869 participants (actual)
- Lead sponsor
- Aarhus University Hospital SkejbyUniversity, hospital or other
- Collaborators
- Vingmed Danmark A/S
- Study start
- 16 Jun 2014 (actual)
- Primary completion
- 16 May 2017 (actual)
- Study completion
- 16 Dec 2018 (actual)
- First posted
- 11 Sep 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.
Is the MynxGrip (test device) non-inferior to manuel compression (standard comparator) in the incidence of adverse access site related events in-hospital, at 30 days and at 6 months.
Detailed description
Prospective, randomized (1:1), controlled, non-blinded, single center study in 2000 patients comparing the MynxGrip (test device) and manuel compression (standard comparator). Safety and efficacy endpoints will be reported for in-hospital, 30 days and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manuel compression | Active comparator | Other: Manual compressionConventional manual compression |
| MynxGrip closure device | Experimental | Device: MynxGripClosure device for femoral artery access closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >18 year
- Should be able to provide valid informed signed consent
- CAG, possibly including intracoronary measurement (FFR) or intracoronary imaging (IVUS, optical coherence tomography (OCT), NIRS)
Key exclusion criteria (16 listed)
- Percutaneous coronary intervention (PCI) procedure and/or implantation of stents
- ST-Elevations Myocardial Infarction (STEMI)
- Multiple punctures
- Active infection
- Groin haematoma before the closure procedure
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 |
|---|---|---|
| MynxGripAlso: Closure deviceClosure device for femoral artery access closure | Device | MynxGrip closure device |
| Manual compressionConventional manual compression | Other | Manuel compression |
Primary outcome
Incidence at 30 days of the composite endpoint of serious access site related major adverse vascular events (MAVE)
Time frame: 30 days
This includes: Major bleeding and/or blood transfusion, pseudoaneurysm with indication for treatment, arteriovenous fistula, groin surgery of leg, definitely or possible can be related to the closure procedure, infection needing antibiotics.
14 secondary outcomes
Time (min) to haemostasis
Time frame: 30 days
Device failure
Time frame: 30 minutes
Vasovagal reaction until 5 minutes after end of closure procedure
Time frame: 30 minutes
Need for new onset of manual compression
Time frame: 30 days
Pain and discomfort related to the closure procedure
Time frame: Closure procedure and 30 days
Time to mobilization
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 days
In-hospital large groin haematoma
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 days
Bleedings according to the Bleeding Academic Research Consortium (BARC) definitions
Time frame: 1 hour and 30 days
Major bleeding and/or bleeding necessitation blood transfusion
Time frame: 30 days and 6 months
Pseudoaneurysm with indication for treatment
Time frame: 30 days and 6 months
Arteriovenous fistula
Time frame: 30 days and 6 months
Groin surgery and/or possible related vascular surgery
Time frame: 30 days and 6 months
Infection needing antibiotics
Time frame: 30 days and 6 months
Need for medical evaluation of possible closure procedure related symptom(s)
Time frame: 30 days
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 8 May 2019.
- Derived from this study: PubMed 35196986Jakobsen L, Holm NR, Maeng M, Thim T, Kristensen SD, Mogensen LH, Christiansen EH. Comparison of MynxGrip vascular closure device and manual compression for closure after femoral access angiography: a randomized controlled trial: the closure devices used in every day practice study, CLOSE-UP III trial. BMC Cardiovasc Disord. 2022 Feb 23;22(1):68. doi: 10.1186/s12872-022-02512-0.
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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.
Evald H Christiansen, MD principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MynxGrip and Manual compression in people with Coronary Disease, run by Aarhus University Hospital Skejby at 1 site in Denmark.
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 3 inclusion and 16 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 8 May 2019. 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 Denmark. 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?
Incidence at 30 days of the composite endpoint of serious access site related major adverse vascular events (MAVE) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02237430, which also lists 1 linked publication.
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 8 May 2019.