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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual puncture point compression | Other | Manual puncture point compression following a diagnostic or therapeutic procedure by endovascular technique involving retrograde femoral puncture point with 5F guide catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual puncture point compression | Other | Manual puncture point compression following a diagnostic or therapeutic procedure by endovascular technique involving retrograde femoral puncture point with 5F guide catheter |
| Measure | Description | Time Frame |
|---|---|---|
| Resumption of walking at H5 will be evaluated by a walking test | 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. | Hour 5 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yann GOUEFFIC, Professor | Nantes University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nantes University Hospital | Nantes | 44093 | France |
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| 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 |
| 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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