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CompletedNCT01001663CLOSE-UP IUpdated Jan 2, 2026

Comparison of the FemoSeal® Arterial Closure Device to Manual Compression After Coronary Angiography

A Phase 4 interventional study of FemoSeal® and Manual compression in Coronary Angiography Via Femoral Artery Access, sponsored by Aarhus University Hospital Skejby. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-02.

Sponsored by Aarhus University Hospital Skejby · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
1,005
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

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Conditions studied

  • Coronary Angiography Via Femoral Artery Access

Keywords

  • CAG
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In context

Lead sponsor

Aarhus University Hospital Skejby is the lead sponsor of 59 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,005 participants (actual)

Study arms

  • Experimental
    FemoSeal®

    Closure device for femoral artery access closure

    Device: FemoSeal®

  • Active comparator
    Manual compression

    Conventional manual compression

    Other: Manual compression

Interventions

  • DeviceFemoSeal®

    Closure device for femoral artery access closure

  • OtherManual compression

    Conventional manual compression

06

What researchers measure

Primary outcomes

  1. Rate of ipsilateral palpable groin hematomas with largest diameter exceeding 5 cm.

    Time frame: 20 minutes, 1 hour and at discharge, pooled

Secondary outcomes

  1. Rate of ipsilateral palpable groin hematomas with largest diameter exceeding 5 cm. Patient self-measurements.

    Time frame: 14 days

  2. 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

  3. Time to hemostasis, from sheath removal to hemostasis is achieved

    Time frame: 14 days

  4. Time from end of closure procedure to ambulation. 1h bedrest recommended.

    Time frame: 14 days

  5. Device deployment failure

    Time frame: 20 minutes

  6. Time to cessation of continuous minor oozing measured from the end of the closure procedure

    Time frame: 14 days

  7. Need for repeated manual compression after end of the closure procedure

    Time frame: 14 days

  8. Pain and discomfort measured on a numerical pain rating scale (0-10)

    Time frame: 20 min

  9. 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

  10. The patient seeking medical assistance for all-cause closure site related symptoms after discharge.

    Time frame: 14 days

  11. Pain and discomfort measured on a numerical pain rating scale (0-10)

    Time frame: 1 hour

  12. Pain and discomfort measured on a numerical pain rating scale (0-10)

    Time frame: Discharge

  13. Pain and discomfort measured on a numerical pain rating scale (0-10)

    Time frame: 14 days

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Study locations

1 site
  • Aarhus University Hospital Skejby
    Aarhus N, 8200, Denmark
08

References and documents

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 24603054 ↗
  • Sindberg 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01001663
Lead sponsor
Aarhus University Hospital Skejby
Collaborators
Vingmed Danmark A/S
Responsible party
Evald Hoej Christiansen (MD, Aarhus University Hospital Skejby) — Principal investigator
First posted
Oct 26, 2009
Start date
Sep 2009
Primary completion
Sep 2010
Completion
Sep 2010
Last update
Jan 2, 2026

Study contacts

Niels R. Holm, MD
principal investigator · Aarhus University Hospital Skejby

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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