Comparison of the FemoSealĀ® Arterial Closure Device to Manual Compression After Coronary Angiography (NCT01001663) | Clinical Trial Compass
CompletedPhase 4
Comparison of the FemoSealĀ® Arterial Closure Device to Manual Compression After Coronary Angiography
Denmark1,005 participantsStarted 2009-09
Plain-language summary
Is the FemoSealĀ® closure device safer and more comfortable than manual compression for femoral artery access closure after coronary angiography?
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Rate of ipsilateral palpable groin hematomas with largest diameter exceeding 5 cm.
Timeframe: 20 minutes, 1 hour and at discharge, pooled