Clinical trial NCT02198612: FREEDOM: "Pilot Study of the Feasibility and Safety of Resuming Early Walking After Manual Compression in Patients Treated for Peripheral Artery Disease by Endovascular Technique Involving Retrograde Femoral Puncture"
Official title: FREEDOM: "Pilot Study of the Feasibility and Safety of Resuming Early Walking After Manual Compression in Patients Treated for Peripheral Artery Disease by Endovascular Technique Involving Retrograde Femoral Puncture"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2014-07-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.


Eligibility criteria: 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

Primary outcomes:
measure: Resumption of walking at H5 will be evaluated by a walking test
timeFrame: Hour 5
Secondary outcomes:
measure: 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)
timeFrame: Hour 5
measure: Occurrence of minor punctured femoral triangle events during the perioperative period, not requiring prolongation of hospitalization, repeat hospitalization or repeat surgery
timeFrame: Hour 5
measure: Time to onset of complications
timeFrame: Hour 5
measure: Puncture point pain (visual analog scale of pain)
timeFrame: Hour 5
measure: Quality of life evaluation (EQ5D questionnaire)
timeFrame: Month 1
measure: Compression time
timeFrame: Hour 5
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Yann GOUEFFIC, Professor
role: STUDY_CHAIR
References: