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COMPLETED
NCT03192033
NA

STEP: Proglide® Versus Femoseal®: A Trial to Compare the Efficacy of Arterial Closure Devices Following Endovascular Peripheral Arterial Procedures

Sponsor: Nantes University Hospital

View on ClinicalTrials.gov

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

Interventions

OTHER

Arterial closure to ensure hemostasis at femoral artery puncture points

Arterial closure devices used: Proglide® (Abbott)

DEVICE

Proglide® (Abbott)

Arterial closure device used: Proglide® (Abbott)

DEVICE

Femoseal® (Terumo)

Arterial closure device used: Femoseal® (Terumo)

OTHER

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