ClinicalTrials.gov
ClinicalTrials.gov Menu

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" (FREEDOM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02198612
Recruitment Status : Completed
First Posted : July 23, 2014
Last Update Posted : December 23, 2015
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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.


Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Other: Manual puncture point compression Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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 Start Date : March 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02198612


Locations
France
Nantes University Hospital
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital
Investigators
Study Chair: Yann GOUEFFIC, Professor Nantes University Hospital

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02198612     History of Changes
Other Study ID Numbers: RC14_0226
First Posted: July 23, 2014    Key Record Dates
Last Update Posted: December 23, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases