Status:
COMPLETED
Comparison of the FemoSeal® Arterial Closure Device to Manual Compression After Coronary Angiography
Lead Sponsor:
Aarhus University Hospital Skejby
Collaborating Sponsors:
Vingmed Danmark A/S
Conditions:
Coronary Angiography Via Femoral Artery Access
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Is the FemoSeal® closure device safer and more comfortable than manual compression for femoral artery access closure after coronary angiography?
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
1005 Patients enrolled
Trial Details
Trial ID
NCT01001663
Start Date
September 1 2009
End Date
September 1 2010
Last Update
January 2 2026
Active Locations (1)
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1
Aarhus University Hospital Skejby
Aarhus N, Denmark, 8200