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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

233 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-04

Study Completion Date

2019-06-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Peripheral Arterial Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A duplex scan guided retrograde femoral puncture is performed followed by the use of a closure arterial device to ensure hemostasis. Patients are randomly assigned to be closed by Proglide® (Abbott) versus Femoseal® (Terumo)

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Arterial closure device used is Proglide® (Abbott)

Group Type OTHER

Arterial closure to ensure hemostasis at femoral artery puncture points

Intervention Type OTHER

Arterial closure devices used: Proglide® (Abbott)

Proglide® (Abbott)

Intervention Type DEVICE

Arterial closure device used: Proglide® (Abbott)

Arterial closure device used is Femoseal® (Terumo)

Group Type OTHER

Femoseal® (Terumo)

Intervention Type DEVICE

Arterial closure device used: Femoseal® (Terumo)

Arterial closure to ensure hemostasis at femoral artery puncture points

Intervention Type OTHER

Arterial closure device used: Femoseal® (Terumo)

Interventions

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Arterial closure to ensure hemostasis at femoral artery puncture points

Arterial closure devices used: Proglide® (Abbott)

Intervention Type OTHER

Proglide® (Abbott)

Arterial closure device used: Proglide® (Abbott)

Intervention Type DEVICE

Femoseal® (Terumo)

Arterial closure device used: Femoseal® (Terumo)

Intervention Type DEVICE

Arterial closure to ensure hemostasis at femoral artery puncture points

Arterial closure device used: Femoseal® (Terumo)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years,
* Patient with peripheral arterial disease
* Endovascular examination or treatment compatible with a 5F to 7F sheath
* Walking ability
* Patient affiliated with a social security scheme
* Patient's signed informed consent form

Exclusion Criteria

* Under-age patient
* Patient of age, but under legal guardianship or care
* Contraindication to endovascular treatment
* Use of a 8F or greater sheath
* Morbidity contraindicating same-day walking
* History of ipsilateral open common femoral artery surgery
* Stent at the puncture site
* Radial or brachial puncture
* Antegrade femoral puncture
* Acute ischemia
* Life expectancy of less than one month
* Patient refusal to take part in the study
* Participation in another therapeutic trial
* Pregnant woman
* Allergy to clopidogrel or aspirin

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No