MedTrace Logo

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"

NCT02198612 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-12-23

No results posted yet for this study

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.

Conditions

  • Peripheral Arterial Disease

Interventions

OTHER

Manual puncture point compression

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

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Yann GOUEFFIC, Professor · Nantes University Hospital

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-07-31
Completion
2015-09-30

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02198612 on ClinicalTrials.gov