An interventional study of Arterial closure to ensure hemostasis at femoral artery puncture points and Proglide® (Abbott) in Peripheral Arterial Disease, sponsored by Nantes University Hospital. Completed at 6 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Nantes University Hospital · Not applicable, Interventional, and Other
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.
1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.
This study's enrollment of 233 is above the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: Arterial closure to ensure hemostasis at femoral artery puncture points · Device: Proglide® (Abbott)
Device: Femoseal® (Terumo) · Other: Arterial closure to ensure hemostasis at femoral artery puncture points
Arterial closure devices used: Proglide® (Abbott)
Arterial closure device used: Proglide® (Abbott)
Arterial closure device used: Femoseal® (Terumo)
Arterial closure device used: Femoseal® (Terumo)
Technical success defined as hemostasis at the puncture site without major complications.
Time frame: Hour 5
Occurrence of major cardio-vascular events
Time frame: Month 1
Occurrence of major punctured femoral artery events during the perioperative period
Time frame: Hour 5
Occurrence of minor punctured femoral artery events during the perioperative period
Time frame: Hour 5
Walking ability
Time before restart of the ambulation measured in minutes from when the sheath of the introducer of the arterial closure system is removed and the moment when the patient is able to walk 100 meters without the recurrence of bleeding.
Time frame: Hour 5
Quality of life evaluation (EQ-5D)
Time frame: Month 1
Cost-Outcome Ratio of patient care with FemoSeal® (St Jude) and Proglide® (Abbott)
The measure of effectiveness will be the utility obtained from the EQ-5D quality of life questionnaire
Time frame: Month 1
Plan to share: No
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Nantes University Hospital