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

Nantes University Hospital (NUH)

Status: Completed

Conditions: Peripheral Arterial Disease

Treatments: Other: Arterial closure to ensure hemostasis at femoral artery puncture points; Device: Proglide® (Abbott); Device: Femoseal® (Terumo)

Study type: Interventional

Funder types: Other

Identifiers

NCT03192033

RC16_0466

Details and patient eligibility

About

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.

Enrollment: 233 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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233 participants in 2 patient groups

Arterial closure device used is Proglide® (Abbott)

Other group

Treatment:

Device: Proglide® (Abbott)

Other: Arterial closure to ensure hemostasis at femoral artery puncture points

Other: Arterial closure to ensure hemostasis at femoral artery puncture points

Arterial closure device used is Femoseal® (Terumo)

Other group

Treatment:

Other: Arterial closure to ensure hemostasis at femoral artery puncture points

Device: Femoseal® (Terumo)

Other: Arterial closure to ensure hemostasis at femoral artery puncture points