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

Phase 4

Completed

• Conditions: Coronary Angiography Via Femoral Artery Access
• Interventions: Device: FemoSeal®; Other: Manual compression

• Registration Number: NCT01001663
• Lead Sponsor: Aarhus University Hospital Skejby

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

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-10-16
• Study First Submitted QC: 2009-10-23
• Study First Posted: 2009-10-26
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-05
• Last Update Posted: 2013-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1005

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FemoSeal®	FemoSeal®	Closure device for femoral artery access closure
Manual compression	Manual compression	Conventional manual compression

Primary Outcome Measures

Name	Time	Method
Rate of ipsilateral palpable groin hematomas with largest diameter exceeding 5 cm.	20 minutes, 1 hour and at discharge, pooled

Secondary Outcome Measures

Name	Time	Method
Need for repeated manual compression after end of the closure procedure	14 days
Pain and discomfort measured on a numerical pain rating scale (0-10)	14 days
Vasovagal reaction (clinical signs AND Systolic BP drop of more than 30 mmHg AND/OR pulse drop more than 30 b/min. AND reversible immediately after treatment by atropin, fluids)	20 minutes
The patient seeking medical assistance for all-cause closure site related symptoms after discharge.	14 days
Rate of ipsilateral palpable groin hematomas with largest diameter exceeding 5 cm. Patient self-measurements.	14 days
Composite of: major vascular complications necessitating surgical repair, A-V fistulation, pseudoaneurysm needing treatment, major bleeding needing transfusion and infection needing antibiotics .	14 days
Time to hemostasis, from sheath removal to hemostasis is achieved	14 days
Time from end of closure procedure to ambulation. 1h bedrest recommended.	14 days
Device deployment failure	20 minutes
Time to cessation of continuous minor oozing measured from the end of the closure procedure	14 days

Trial Locations

Locations (1)

Aarhus University Hospital Skejby; 🇩🇰 Aarhus N, Denmark