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

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

Detailed Description
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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.

Official Title
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Comparison of the FemoSeal® Arterial Closure Device to Manual Compression After Coronary Angiography: the CLOSE-UP I Randomized Trial

Conditions
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Coronary Angiography Via Femoral Artery Access

Intervention / Treatment
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* Device: FemoSeal®
* Other: Manual compression


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FemoSeal®<br>Closure device for femoral artery access closure | Device: FemoSeal®<br>* Closure device for femoral artery access closure<br>|
| Active Comparator: Manual compression<br>Conventional manual compression | Other: Manual compression<br>* Conventional manual compression<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of ipsilateral palpable groin hematomas with largest diameter exceeding 5 cm. |  | 20 minutes, 1 hour and at discharge, pooled | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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) |  | 20 min | 
| 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 | 
| Pain and discomfort measured on a numerical pain rating scale (0-10) |  | 1 hour | 
| Pain and discomfort measured on a numerical pain rating scale (0-10) |  | Discharge | 
| Pain and discomfort measured on a numerical pain rating scale (0-10) |  | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CAG