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

NCT03192033 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 233

Last updated 2019-07-05

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Philippe CHAILLOU, Doctor · Nantes University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-04
Primary Completion
2019-06-25
Completion
2019-06-25

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03192033 on ClinicalTrials.gov