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"

Peripheral Arterial Disease Clinical Trial

— FREEDOM  

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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02198612
• Other study ID #: RC14_0226
• Status: Completed
• Phase: N/A
• First received: July 15, 2014
• Last updated: December 22, 2015
• Start date: March 2015
• Est. completion date: September 2015

Study information

• Verified date: December 2015
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	Occurrence of minor punctured femoral triangle events during the perioperative period, not requiring prolongation of hospitalization, repeat hospitalization or repeat surgery		Hour 5	Yes
Secondary	Time to onset of complications		Hour 5	No
Secondary	Puncture point pain (visual analog scale of pain)		Hour 5	No
Secondary	Quality of life evaluation (EQ5D questionnaire)		Month 1	No
Secondary	Compression time		Hour 5	No