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 | Completed

• 1 other identifier: RC14_0226
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Resumption of walking at H5 will be evaluated by a walking test

  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.

  Hour 5

Secondary Outcomes (6)

• 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)

  Hour 5

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

  Hour 5

• Time to onset of complications

  Hour 5

• Puncture point pain (visual analog scale of pain)

  Hour 5

• Quality of life evaluation (EQ5D questionnaire)

  Month 1

Study Arms (1)

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

Other: Manual puncture point compression

Interventions

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

Manual puncture point compression

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Yann GOUEFFIC, Professor

  Nantes University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2014
• First Posted: July 23, 2014
• Study Start: March 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: September 1, 2015
• Last Updated: December 23, 2015

Record last verified: 2015-12

Locations

FR (1)