Coronary Angiography Via Femoral Artery AccessPhase 4CLOSE-UP INCT01001663
Comparison of the FemoSeal® Arterial Closure Device to Manual Compression After Coronary Angiography
A Phase 4 study testing FemoSeal® and Manual compression in people with Coronary Angiography Via Femoral Artery Access, run by Aarhus University Hospital Skejby at 1 site in Denmark.
Trial summary
Is the FemoSeal® closure device safer and more comfortable than manual compression for femoral artery access closure after coronary angiography? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Angiography Via Femoral Artery Access
- What is being tested?
- FemoSeal® and Manual compression
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,005 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2009to Sep 2010
- Phase
- Phase 4
- 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
- The patient must be at least 18 years old
- Patients undergoing femoral access coronary angiography
- Patient must be competent for providing informed, written consent
- Only 6F sheath
Who cannot join
- Percutaneous coronary intervention
- Intra coronary measurements (FFR, IVUS, OCT, NIR)
- Groin hematoma before closure
- Pseudoaneurysm or AV fistula
- Significant stenosis of ilial or femoral artery
- Prior peripheral artery surgery
Show all 14Show fewer
- INR > 3,0
- Platelet count < 120 million per millilitre blood
- Coagulopathy (bleeding disorder)
- Thrombolysis in the last 24h
- Planned heparin infusion after the procedure
- Pregnancy
- Uncontrolled hypertension > 200 mmHg / 110 mmHg
- Femoral access device closure in the last 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the FemoSeal® Arterial Closure Device to Manual Compression After Coronary Angiography: the CLOSE-UP I Randomized Trial
Is the FemoSeal® closure device safer and more comfortable than manual compression for femoral artery access closure after coronary angiography?
Read the detailed description
Access site complication after coronary angiography is still a challenge in everyday practice. The FemoSeal® closure device has proven very safe as shown in the swedish SCAAR registry. This study is aimed to investigate, in a randomized design, if the FemoSeal® has an advantage in safety and efficacy over manual compression.
- Being tested
- FemoSeal®, Manual compression
- Keywords
- CAG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FemoSeal®Device
Closure device for femoral artery access closure
Manual compressionOther
Conventional manual compression
| Study group | Role | What they receive |
|---|---|---|
| FemoSeal® | Experimental | Closure device for femoral artery access closure Receives: Device: FemoSeal® |
| Manual compression | Active comparator | Conventional manual compression Receives: Other: Manual compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of ipsilateral palpable groin hematomas with largest diameter exceeding 5 cm.
Measured: 20 minutes, 1 hour and at discharge, pooled
Secondary outcomes (13)
Rate of ipsilateral palpable groin hematomas with largest diameter exceeding 5 cm. Patient self-measurements.
Measured: 14 days
Composite of: major vascular complications necessitating surgical repair, A-V fistulation, pseudoaneurysm needing treatment, major bleeding needing transfusion and infection needing antibiotics .
Measured: 14 days
Time to hemostasis, from sheath removal to hemostasis is achieved
Measured: 14 days
Time from end of closure procedure to ambulation. 1h bedrest recommended.
Measured: 14 days
Device deployment failure
Measured: 20 minutes
Time to cessation of continuous minor oozing measured from the end of the closure procedure
Measured: 14 days
Need for repeated manual compression after end of the closure procedure
Measured: 14 days
Pain and discomfort measured on a numerical pain rating scale (0-10)
Measured: 20 min
Vasovagal reaction (clinical signs AND Systolic BP drop of more than 30 mmHg AND/OR pulse drop more than 30 b/min. AND reversible immediately after treatment by atropin, fluids)
Measured: 20 minutes
The patient seeking medical assistance for all-cause closure site related symptoms after discharge.
Measured: 14 days
Pain and discomfort measured on a numerical pain rating scale (0-10)
Measured: 1 hour
Pain and discomfort measured on a numerical pain rating scale (0-10)
Measured: Discharge
Pain and discomfort measured on a numerical pain rating scale (0-10)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Angiography Via Femoral Artery AccessStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,005 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
- Niels R. Holm, MD, Principal investigator, Aarhus University Hospital Skejby
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01001663
- Sponsor's protocol ID
- M-20090101
- Acronym
- CLOSE-UP I
- Status last verified
- Dec 2025
- First submitted
- 16 Oct 2009
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Holm NR, Sindberg B, Schou M, Maeng M, Kaltoft A, Bottcher M, Krusell LR, Hjort J, Thuesen L, Terkelsen CJ, Christiansen EH, Botker HE, Kristensen SD, Lassen JF; CLOSE-UP study group. Randomised comparison of manual compression and FemoSeal vascular closure device for closure after femoral artery access coronary angiography: the CLOSure dEvices Used in everyday Practice (CLOSE-UP) study. EuroIntervention. 2014 Jun;10(2):183-90. doi: 10.4244/EIJV10I2A31.
PubMed 24603054Sindberg B, Schou M, Hansen L, Christiansen KJ, Jorgensen KS, Soltoft M, Holm NR, Maeng M, Kristensen SD, Lassen JF. Pain and discomfort in closure of femoral access coronary angiography. The CLOSuredEvices Used in everyday Practice (CLOSE-UP) pain sub study. Eur J Cardiovasc Nurs. 2014 Jun;13(3):221-6. doi: 10.1177/1474515113482809. Epub 2013 Mar 25.
PubMed 23532433
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the FemoSeal® Arterial Closure Device to Manual Compression After Coronary Angiography: the CLOSE-UP I Randomized Trial
- ClinicalTrials.gov ID
- NCT01001663
- Acronym / sponsor ID
- CLOSE-UP I / M-20090101
- Keywords
- CAG
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,005 participants (actual)
- Lead sponsor
- Aarhus University Hospital SkejbyUniversity, hospital or other
- Collaborators
- Vingmed Danmark A/S
- Study start
- Sep 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 26 Oct 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.
Is the FemoSeal® closure device safer and more comfortable than manual compression for femoral artery access closure after coronary angiography?
Detailed description
Access site complication after coronary angiography is still a challenge in everyday practice. The FemoSeal® closure device has proven very safe as shown in the swedish SCAAR registry. This study is aimed to investigate, in a randomized design, if the FemoSeal® has an advantage in safety and efficacy over manual compression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FemoSeal® | Experimental | Device: FemoSeal®Closure device for femoral artery access closure |
| Manual compression | Active comparator | Other: Manual compressionConventional manual compression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient must be at least 18 years old
- Patients undergoing femoral access coronary angiography
- Patient must be competent for providing informed, written consent
- Only 6F sheath
Key exclusion criteria (14 listed)
- Percutaneous coronary intervention
- Intra coronary measurements (FFR, IVUS, OCT, NIR)
- Groin hematoma before closure
- Pseudoaneurysm or AV fistula
- Significant stenosis of ilial or 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 |
|---|---|---|
| FemoSeal®Closure device for femoral artery access closure | Device | FemoSeal® |
| Manual compressionConventional manual compression | Other | Manual compression |
Primary outcome
Rate of ipsilateral palpable groin hematomas with largest diameter exceeding 5 cm.
Time frame: 20 minutes, 1 hour and at discharge, pooled
13 secondary outcomes
Rate of ipsilateral palpable groin hematomas with largest diameter exceeding 5 cm. Patient self-measurements.
Time frame: 14 days
Composite of: major vascular complications necessitating surgical repair, A-V fistulation, pseudoaneurysm needing treatment, major bleeding needing transfusion and infection needing antibiotics .
Time frame: 14 days
Time to hemostasis, from sheath removal to hemostasis is achieved
Time frame: 14 days
Time from end of closure procedure to ambulation. 1h bedrest recommended.
Time frame: 14 days
Device deployment failure
Time frame: 20 minutes
Time to cessation of continuous minor oozing measured from the end of the closure procedure
Time frame: 14 days
Need for repeated manual compression after end of the closure procedure
Time frame: 14 days
Pain and discomfort measured on a numerical pain rating scale (0-10)
Time frame: 20 min
Vasovagal reaction (clinical signs AND Systolic BP drop of more than 30 mmHg AND/OR pulse drop more than 30 b/min. AND reversible immediately after treatment by atropin, fluids)
Time frame: 20 minutes
The patient seeking medical assistance for all-cause closure site related symptoms after discharge.
Time frame: 14 days
Pain and discomfort measured on a numerical pain rating scale (0-10)
Time frame: 1 hour
Pain and discomfort measured on a numerical pain rating scale (0-10)
Time frame: Discharge
Pain and discomfort measured on a numerical pain rating scale (0-10)
Time frame: 14 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 2 Jan 2026.
- Derived from this study: PubMed 24603054Holm NR, Sindberg B, Schou M, Maeng M, Kaltoft A, Bottcher M, Krusell LR, Hjort J, Thuesen L, Terkelsen CJ, Christiansen EH, Botker HE, Kristensen SD, Lassen JF; CLOSE-UP study group. Randomised comparison of manual compression and FemoSeal vascular closure device for closure after femoral artery access coronary angiography: the CLOSure dEvices Used in everyday Practice (CLOSE-UP) study. EuroIntervention. 2014 Jun;10(2):183-90. doi: 10.4244/EIJV10I2A31.
- Derived from this study: PubMed 23532433Sindberg B, Schou M, Hansen L, Christiansen KJ, Jorgensen KS, Soltoft M, Holm NR, Maeng M, Kristensen SD, Lassen JF. Pain and discomfort in closure of femoral access coronary angiography. The CLOSuredEvices Used in everyday Practice (CLOSE-UP) pain sub study. Eur J Cardiovasc Nurs. 2014 Jun;13(3):221-6. doi: 10.1177/1474515113482809. Epub 2013 Mar 25.
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.
Niels R. Holm, MD principal investigator
Aarhus University Hospital Skejby
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing FemoSeal® and Manual compression in people with Coronary Angiography Via Femoral Artery Access, 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 4 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 2 Jan 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Rate of ipsilateral palpable groin hematomas with largest diameter exceeding 5 cm. (time frame: 20 minutes, 1 hour and at discharge, pooled). 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 NCT01001663, which also lists 2 linked publications.
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 2 Jan 2026.