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"

Nantes University Hospital (NUH)

Status: Completed

Conditions: Peripheral Arterial Disease

Treatments: Other: Manual puncture point compression

Study type: Interventional

Funder types: Other

Identifiers

NCT02198612

RC14_0226

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

Manual puncture point compression

Other group

Description:

Manual puncture point compression following a diagnostic or therapeutic procedure by endovascular technique involving retrograde femoral puncture point with 5F guide catheter

Treatment:

Other: Manual puncture point compression