Comparison of the FemoSeal® Arterial Closure Device to Manual Compression After Coronary Angiography (CLOSE-UP I)

Aarhus University Hospital Skejby

Status and phase: Completed; Phase 4

Conditions: Coronary Angiography Via Femoral Artery Access

Treatments: Other: Manual compression; Device: FemoSeal®

Study type: Interventional

Funder types: Other

Identifiers

NCT01001663

M-20090101

Details and patient eligibility

About

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

Full 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 aimed to investigate, in a randomized design, if the FemoSeal® has an advantage in safety and efficacy over manual compression.

Enrollment: 1,005 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,005 participants in 2 patient groups

FemoSeal®

Experimental group

Description:

Closure device for femoral artery access closure

Treatment:

Device: FemoSeal®

Manual compression

Active Comparator group

Description:

Conventional manual compression

Treatment:

Other: Manual compression