Status:
COMPLETED
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"
Lead Sponsor:
Nantes University Hospital
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02198612
Start Date
March 1 2015
End Date
September 1 2015
Last Update
December 23 2015
Active Locations (1)
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1
Nantes University Hospital
Nantes, France, 44093