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Completed

NCT Number: 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"

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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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nantes University Hospital

Nantes, 44093, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Resumption of walking at H5 will be evaluated by a walking test

    Time frame: Hour 5

    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.

Secondary outcomes

  1. 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)

    Time frame: Hour 5

  2. Occurrence of minor punctured femoral triangle events during the perioperative period, not requiring prolongation of hospitalization, repeat hospitalization or repeat surgery

    Time frame: Hour 5

  3. Time to onset of complications

    Time frame: Hour 5

  4. Puncture point pain (visual analog scale of pain)

    Time frame: Hour 5

  5. Quality of life evaluation (EQ5D questionnaire)

    Time frame: Month 1

  6. Compression time

    Time frame: Hour 5

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: FREEDOM

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 23, 2014
Registry last updated
Dec 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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