New device may reduce bruising after heart procedure
NCT ID NCT01001663
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a device called FemoSeal is safer and more comfortable than pressing on the groin by hand after a heart artery imaging test. About 1,000 adults having the test through the groin took part. The main goal was to see if the device led to fewer large bruises.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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1,005 people
The number who actually took part.
- Start date
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Sep 2009
- Finished
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Sep 2010
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Aarhus University Hospital Skejby
Aarhus N, 8200, Denmark