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. According to certain studies however, it would appear that arterial closure devices do not present any greater benefits than manual compression in terms of hemostasis and complications. Moreover, the use of increasingly small diameter instruments would tend to render manual compression sufficient. Finally, the use of these devices generates additional costs. The purpose of our study is to evaluate the feasibility and safety of manual compression before early resumption of walking in patients managed by conventional hospitalization for a diagnostic or therapeutic endovascular procedures by retrograde femoral puncture with 5F guide catheter.
Interventions
Manual puncture point compression following a diagnostic or therapeutic procedure by endovascular technique involving retrograde femoral puncture point with 5F guide catheter
Sponsors
Nantes University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years, * Endovascular examination or treatment compatible with a 5F guide catheter * Walking ability * Patient affiliated with a social security scheme * Patient's signed informed consent form
Exclusion criteria
* Underage patient * Patient of age, but under legal guardianship or care * Contraindication to endovascular treatment * Use of a 6F or greater guide catheter * Morbidity contraindicating same-day walking * History of punctured open femoral triangle surgery * Radial or humeral puncture * Bilateral femoral puncture * Anterograde femoral puncture * Acute ischemia * Anticoagulant treatment * Allergy to Elastoplast® type adhesive strips * Life expectancy of less than one month * Patient refusal to take part in the study * Participation in another therapeutic trial * Pregnant woman * Patients who do not speak French, refusing or incapable of the follow-up proposed by the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resumption of walking at H5 will be evaluated by a walking test | Hour 5 | To demonstrate the feasibility of early resumption of walking after manual puncture point compression following a diagnostic or therapeutic procedure by endovascular technique involving retrograde femoral puncture point with 5F guide catheter. |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of major punctured femoral triangle events during the perioperative period, requiring prolongation of hospitalization, repeat hospitalization or repeat surgery (hematoma, hemorrhage or false aneurysm) | Hour 5 |
| Occurrence of minor punctured femoral triangle events during the perioperative period, not requiring prolongation of hospitalization, repeat hospitalization or repeat surgery | Hour 5 |
| Time to onset of complications | Hour 5 |
| Puncture point pain (visual analog scale of pain) | Hour 5 |
| Quality of life evaluation (EQ5D questionnaire) | Month 1 |
| Compression time | Hour 5 |
Countries
France
Contacts
STUDY_CHAIRYann GOUEFFIC, Professor
Nantes University Hospital
Outcome results
None listed