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OpenTrials
Completed

NCT Number: NCT01001663

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

Is the FemoSeal® closure device safer and more comfortable than manual compression for femoral artery access closure after coronary angiography?

Completed

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Key information

Conditions

Coronary Angiography Via Femoral Artery Access

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aarhus University Hospital Skejby

Aarhus N, 8200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

FemoSeal®

Device

Closure device for femoral artery access closure

Manual compression

Other

Conventional manual compression

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

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital Skejby

Other

Collaborators

  • Vingmed Danmark A/S

Registry information

Official study title

Comparison of the FemoSeal® Arterial Closure Device to Manual Compression After Coronary Angiography: the CLOSE-UP I Randomized Trial

Acronym: CLOSE-UP I

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 26, 2009
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.