Over the past years, arterial closure systems have tended to replace manual compression to ensure hemostasis at femoral artery puncture points. Arterial closure systems reduce hemostasis and patient immobilization times, thus enabling early resumption of walking. These devices have contributed extensively to the development of outpatient stays for cardiology, vascular and neuro-radiology procedures. However, main arterial closure devices use different technology to close the arterial puncture point. For some, hemostasis is achieved by sealing the arteriotomy between two discs (an inner and an outer). For others, they are designed to close puncture sites delivering a single monofilament polypropylene suture mediated by needles. The investigators hypothesis is based on a different efficacy between both arterial closure devices for peripheral arterial disease (PAD) patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
233
Arterial closure devices used: Proglide® (Abbott)
Arterial closure device used: Proglide® (Abbott)
Arterial closure device used: Femoseal® (Terumo)
Arterial closure device used: Femoseal® (Terumo)
CHU Angers
Angers, France
CHU Brest
Brest, France
CH de Cholet
Cholet, France
CHD La Roche-sur-Yon
La Roche-sur-Yon, France
CHU de Poitiers
Poitiers, France
CHU de Rennes
Rennes, France
Technical success defined as hemostasis at the puncture site without major complications.
Time frame: Hour 5
Occurrence of major cardio-vascular events
Time frame: Month 1
Occurrence of major punctured femoral artery events during the perioperative period
Time frame: Hour 5
Occurrence of minor punctured femoral artery events during the perioperative period
Time frame: Hour 5
Walking ability
Time before restart of the ambulation measured in minutes from when the sheath of the introducer of the arterial closure system is removed and the moment when the patient is able to walk 100 meters without the recurrence of bleeding.
Time frame: Hour 5
Quality of life evaluation (EQ-5D)
Time frame: Month 1
Cost-Outcome Ratio of patient care with FemoSeal® (St Jude) and Proglide® (Abbott)
The measure of effectiveness will be the utility obtained from the EQ-5D quality of life questionnaire
Time frame: Month 1
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