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

Study Overview
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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.

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

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* 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


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arterial closure device used is Proglide® (Abbott)<br> | Other: Arterial closure to ensure hemostasis at femoral artery puncture points<br>* Arterial closure devices used: Proglide® (Abbott)<br>Device: Proglide® (Abbott)<br>* Arterial closure device used: Proglide® (Abbott)<br>|
| Other: Arterial closure device used is Femoseal® (Terumo)<br> | Device: Femoseal® (Terumo)<br>* Arterial closure device used: Femoseal® (Terumo)<br>Other: Arterial closure to ensure hemostasis at femoral artery puncture points<br>* Arterial closure device used: Femoseal® (Terumo)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success defined as hemostasis at the puncture site without major complications. |  | Hour 5 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |