Coronary DiseaseCLOSE-UP IINCT02234830
Randomized Comparison of ExoSeal® and Angio-Seal Vascular Closure Devices: The CLOSE-UP II Trial
A study testing Exoseal closure device and Angioseal closure device in people with Coronary Disease, run by Aarhus University Hospital Skejby at 2 sites in Denmark.
Trial summary
Is the ExoSeal VSD non-inferior to Angio-Seal vascular closure device (VSD) in the incidence of adverse access site related events at 30 days. 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?
- Exoseal closure device and Angioseal closure device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 818 participants
- Where
- 2 sitesDenmark
- Study dates
- 21 Dec 2012to 14 May 2017
- 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
- Should be able to provide valid informed signed consent
- PCI procedure including treatment by balloon and/or stent
- PCI indicated by silent ischemia, stable angina pectoris, non-ST elevation myocardial infarction (NSTEMI) or ST elevation myocardial infarction (STEMI)
Who cannot join
- Only coronary angiography
- Multiple punctures
- Active infection
- Groin haematoma before the closure procedure
- Sheath size > 7 French
- Known pseudoaneurysm or arteriovenous (AV)-fistula in the ipsilateral groin
Show all 14Show fewer
- Prior arterial surgery in abdomen and/or lower extremities
- Cardiogenic shock
- Life expectancy less than one year
- The patient is a female of childbearing potential with possible pregnancy or a positive pregnancy test within 7 days before the index procedure or is lactating
- Simultaneous or planned subsequent femoral vein access
- Allergy to any of the components in the closure material left in the groin
- Puncture on same site < 30 days
- Peripheral artery disease patients can be included at operator´s discretion except if heavy calcification is present at the access site which at the operator's discretion precludes insertion of the VCD
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Aarhus University Hospital
Aarhus N, 8200
Odense University Hospital
Odense, 5000
About this study
Is the ExoSeal VSD non-inferior to Angio-Seal vascular closure device (VSD) in the incidence of adverse access site related events at 30 days.
Read the detailed description
Prospective, randomized (1:1) controlled, single blind, single center study in 2000 percutaneous coronary intervention (PCI) patients comparing the ExoSeal VCD (test device) to the AngioSeal VCD (standard comparator). In-hospital and 30 days safety and efficacy endpoints and 6 months safety endpoints will be reported.
- Conditions
- Coronary Disease
- Being tested
- Exoseal closure device, Angioseal closure device
- Keywords
- PCI
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exoseal closure deviceDevice
Closure device for femoral artery access closure
Angioseal closure deviceDevice
Closure device for femoral artery access closure
| Study group | Role | What they receive |
|---|---|---|
| Exoseal closure device | Experimental | Closure device for femoral artery access closure Receives: Device: Exoseal closure device |
| Angio-Seal closure device | Active comparator | Closure device for femoral artery access closure Receives: Device: Angioseal closure device |
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 access site related major adverse vascular events (MAVE)
This includes: major bleeding and/or bleeding necessitating blood transfusion, pseudoaneurysm with indication for treatment, arteriovenous fistula, groin surgery and/or possible related vascular surgery, infection needing antibiotics.
Measured: 30 days
Secondary outcomes (14)
Time to haemostasis from removing the sheath (AngioSeal) or inserting the device (ExoSeal) until haemostasis
Insignificant bleeding seen on the bandage or small continuous oozing is considered haemostasis. Continuous oozing will be counted as a Bleeding Academic Research Consortium (BARC) type 1 bleeding event
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 days
Device failure
Combined endpoint of any mechanic failure, deployment failure and/or immediate profuse bleeding needing prolonged manual compression. Individual endpoints will be reported.
Measured: 30 minutes
Vasovagal reaction until 5 minutes after end of closure procedure
Measured: 30 minuts
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) Scripted language will be used when discussing pain scores with the patient. Pain and discomfort score will be assessed just before and immediately after the closure procedure and reported. The delta-value will be reported and compared. The patient will be given predefined standardized instructions on how to rate and that only pain and discomfort related to the closure procedure should be assessed
Measured: Closure procedure and 30 days
Time to mobilization
From start of closure procedure to patient is mobilized. Patients treated for ST-elevation myocardial infarction are assessed separately
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 days
In-hospital large groin haematoma
Larger than 5x5 cm measured by ruler in the catheterization laboratory and at discharge
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 days
Bleedings according to the BARC definitions
Access site related and non-access site related
Measured: 30 days
Major bleeding and/or bleeding necessitating blood transfusion
Measured: 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 posted9 Sep 2014 (estimated)
- Study start21 Dec 2012
- Primary completion14 May 2016
- Study completion14 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 818 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital Skejby
- Sponsor type
- University, hospital or other
- Collaborators
- Cordis US Corp., Abbott Medical Devices
- Responsible party
- Principal investigator, Evald Hoej Christiansen, Aarhus University Hospital Skejby
- Investigators
- Evald H Christiansen, MD, PhD, Principal investigator, Arhus University Hospital Skejby
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02234830
- Sponsor's protocol ID
- 1-10-72-68-12
- Acronym
- CLOSE-UP II
- Status last verified
- May 2017
- First submitted
- 6 Jun 2014
- Last updated
- 1 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of ExoSeal® and Angio-Seal Vascular Closure Devices: The CLOSE-UP II Trial
- ClinicalTrials.gov ID
- NCT02234830
- Acronym / sponsor ID
- CLOSE-UP II / 1-10-72-68-12
- Conditions
- Coronary Disease
- Keywords
- PCI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 818 participants (actual)
- Lead sponsor
- Aarhus University Hospital SkejbyUniversity, hospital or other
- Collaborators
- Cordis US Corp., Abbott Medical Devices
- Study start
- 21 Dec 2012 (actual)
- Primary completion
- 14 May 2016 (actual)
- Study completion
- 14 May 2017 (actual)
- First posted
- 9 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 ExoSeal VSD non-inferior to Angio-Seal vascular closure device (VSD) in the incidence of adverse access site related events at 30 days.
Detailed description
Prospective, randomized (1:1) controlled, single blind, single center study in 2000 percutaneous coronary intervention (PCI) patients comparing the ExoSeal VCD (test device) to the AngioSeal VCD (standard comparator). In-hospital and 30 days safety and efficacy endpoints and 6 months safety endpoints will be reported.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exoseal closure device | Experimental | Device: Exoseal closure deviceClosure device for femoral artery access closure |
| Angio-Seal closure device | Active comparator | Device: Angioseal closure deviceClosure 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)
- Should be able to provide valid informed signed consent
- PCI procedure including treatment by balloon and/or stent
- PCI indicated by silent ischemia, stable angina pectoris, non-ST elevation myocardial infarction (NSTEMI) or ST elevation myocardial infarction (STEMI)
Key exclusion criteria (14 listed)
- Only coronary angiography
- Multiple punctures
- Active infection
- Groin haematoma before the closure procedure
- Sheath size > 7 French
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 |
|---|---|---|
| Exoseal closure deviceClosure device for femoral artery access closure | Device | Exoseal closure device |
| Angioseal closure deviceClosure device for femoral artery access closure | Device | Angio-Seal closure device |
Primary outcome
Incidence at 30 days of the composite endpoint of access site related major adverse vascular events (MAVE)
Time frame: 30 days
This includes: major bleeding and/or bleeding necessitating blood transfusion, pseudoaneurysm with indication for treatment, arteriovenous fistula, groin surgery and/or possible related vascular surgery, infection needing antibiotics.
14 secondary outcomes
Time to haemostasis from removing the sheath (AngioSeal) or inserting the device (ExoSeal) until haemostasis
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 days
Device failure
Time frame: 30 minutes
Vasovagal reaction until 5 minutes after end of closure procedure
Time frame: 30 minuts
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 BARC definitions
Time frame: 30 days
Major bleeding and/or bleeding necessitating blood transfusion
Time frame: 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 1 Jun 2017.
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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, PhD principal investigator
Arhus University Hospital Skejby
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exoseal closure device and Angioseal closure device in people with Coronary Disease, run by Aarhus University Hospital Skejby at 2 sites 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 14 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 1 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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?
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 1 Jun 2017.