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

Aarhus University Hospital Skejby1,005 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,005

Conditions

Coronary Angiography Via Femoral Artery Access

Interventions

FemoSeal®DEVICE

Closure device for femoral artery access closure

Manual compressionOTHER

Conventional manual compression

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Aarhus University Hospital Skejby

Aarhus N, Denmark

Outcomes

Primary Outcomes

Rate of ipsilateral palpable groin hematomas with largest diameter exceeding 5 cm.

Time frame: 20 minutes, 1 hour and at discharge, pooled

Secondary Outcomes

Rate of ipsilateral palpable groin hematomas with largest diameter exceeding 5 cm. Patient self-measurements.

Time frame: 14 days

Composite of: major vascular complications necessitating surgical repair, A-V fistulation, pseudoaneurysm needing treatment, major bleeding needing transfusion and infection needing antibiotics .

Time frame: 14 days

Time to hemostasis, from sheath removal to hemostasis is achieved

Time frame: 14 days

Time from end of closure procedure to ambulation. 1h bedrest recommended.

Time frame: 14 days

Device deployment failure

Time frame: 20 minutes

Time to cessation of continuous minor oozing measured from the end of the closure procedure

Time frame: 14 days

Need for repeated manual compression after end of the closure procedure

Time frame: 14 days

Pain and discomfort measured on a numerical pain rating scale (0-10)

Time frame: 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)

Data from ClinicalTrials.gov

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