NCT03192033: STEP

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

Completed NA Last updated 5 July 2019

What this trial tests

NA trial testing Arterial closure to ensure hemostasis at femoral artery puncture points in Peripheral Arterial Disease in 233 participants. Completed in 25 June 2019.

Timeline

4 December 2017

Primary endpoint
25 June 2019

25 June 2019

Quick facts

Lead sponsor	Nantes University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	233
Start date	4 December 2017
Primary completion	25 June 2019
Estimated completion	25 June 2019
Sites	6 locations across France

Drugs / interventions tested

• Arterial closure to ensure hemostasis at femoral artery puncture points
• Proglide® (Abbott)
• Femoseal® (Terumo)
• Arterial closure to ensure hemostasis at femoral artery puncture points

Conditions studied

• Peripheral Arterial Disease — all drugs for Peripheral Arterial Disease →

Sponsor

Nantes University Hospital

Who can join

18 and older, any sex, with Peripheral Arterial Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A Randomized Trial Comparing Polymer Versus Suture-Based Vascular Closure Devices for Arterial Closure Following Lower-Limb Arterial Endovascular Revascularization.
   Gouëffic Y, Picquet J, Schneider F, Kaladji A, et al · · 2021 · cited 6× · PMID 34386892 · DOI 10.1007/s00270-021-02940-z