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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arterial closure device used is Proglide® (Abbott) | Other |
| |
| Arterial closure device used is Femoseal® (Terumo) | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arterial closure to ensure hemostasis at femoral artery puncture points | Other | Arterial closure devices used: Proglide® (Abbott) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Technical success defined as hemostasis at the puncture site without major complications. | Hour 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of major cardio-vascular events | Month 1 | |
| Occurrence of major punctured femoral artery events during the perioperative period | Hour 5 | |
| Occurrence of minor punctured femoral artery events during the perioperative period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe CHAILLOU, Doctor | Nantes University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Angers | Angers | France | ||||
| CHU Brest |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34386892 | Derived | Goueffic Y, Picquet J, Schneider F, Kaladji A, Marret O, Muller L, Guyomarc'h B, Riche VP, Chaillou P, Guillou M, Nasr B. A Randomized Trial Comparing Polymer Versus Suture-Based Vascular Closure Devices for Arterial Closure Following Lower-Limb Arterial Endovascular Revascularization. Cardiovasc Intervent Radiol. 2021 Dec;44(12):1883-1892. doi: 10.1007/s00270-021-02940-z. Epub 2021 Aug 13. |
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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)
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| Proglide® (Abbott) | Device | Arterial closure device used: Proglide® (Abbott) |
|
| Femoseal® (Terumo) | Device | Arterial closure device used: Femoseal® (Terumo) |
|
| Arterial closure to ensure hemostasis at femoral artery puncture points | Other | Arterial closure device used: Femoseal® (Terumo) |
|
| 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. | Hour 5 |
| Quality of life evaluation (EQ-5D) | 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 | Month 1 |
| Brest |
| France |
| CH de Cholet | Cholet | France |
| CHD La Roche-sur-Yon | La Roche-sur-Yon | France |
| CHU de Poitiers | Poitiers | France |
| CHU de Rennes | Rennes | France |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
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