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

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?

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.

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