Peripheral Arterial Disease
Conditions
Brief summary
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.
Interventions
OTHERArterial closure to ensure hemostasis at femoral artery puncture points
Arterial closure devices used: Proglide® (Abbott)
DEVICEProglide® (Abbott)
Arterial closure device used: Proglide® (Abbott)
DEVICEFemoseal® (Terumo)
Arterial closure device used: Femoseal® (Terumo)
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention 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)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Technical success defined as hemostasis at the puncture site without major complications. | Hour 5 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Hour 5 | 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. |
| Quality of life evaluation (EQ-5D) | Month 1 | — |
| Cost-Outcome Ratio of patient care with FemoSeal® (St Jude) and Proglide® (Abbott) | Month 1 | The measure of effectiveness will be the utility obtained from the EQ-5D quality of life questionnaire |
Countries
France
Contacts
STUDY_CHAIRPhilippe CHAILLOU, Doctor
Nantes University Hospital
Outcome results
None listed