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STEP: Proglide® Versus Femoseal®: A Trial to Compare the Efficacy of Arterial Closure Devices Following Endovascular Peripheral Arterial Procedures
Sponsor: Nantes University Hospital
Summary
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.
Official title: STEP: Proglide® Versus Femoseal®: A Randomized Controlled Trial to Compare the Efficacy of Arterial Closure Devices Following Endovascular Peripheral Arterial Procedures
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
233
Start Date
2017-12-04
Completion Date
2019-06-25
Last Updated
2026-09-14
Healthy Volunteers
No
Conditions
Interventions
Arterial closure to ensure hemostasis at femoral artery puncture points
Arterial closure devices used: Proglide® (Abbott)
Proglide® (Abbott)
Arterial closure device used: Proglide® (Abbott)
Femoseal® (Terumo)
Arterial closure device used: Femoseal® (Terumo)
Arterial closure to ensure hemostasis at femoral artery puncture points
Arterial closure device used: Femoseal® (Terumo)
Locations (6)
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