NCT03192033

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 233 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2017-12-04
• Primary completion: 2019-06-25
• Completion: 2019-06-25
• First posted: 2017-06-19
• Last updated: 2019-07-05

Locations

6 sites across 1 country: France