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Feasibility of Outpatient Care After Manual Compression in Patients Treated for Peripheral Arterial Disease by Endovascular Technique With 5F Sheath Femoral Approach (FREEDOM OP)

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ClinicalTrials.gov Identifier: NCT03185052
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : December 6, 2017
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 prospective study is to evaluate the feasibility and safety of same-day discharge after manual compression in patients treated for peripheral artery disease by endovascular technique with 5F sheath.


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

Detailed Description:

The reference management strategies for patients treated for peripheral arterial disease by endovascular technique are conventional hospitalization with manual compression and discharge after at least one over-night observation and outpatient hospitalization with the use of an arterial closure device. There are currently no official guidelines for guiding the patient towards one or other of these types of care. Indeed, outpatient management of artery disease is implemented in only a few centers in France. Several studies have shown that outpatient care is perfectly safe for patients. Our experiment at the Nantes University Hospital demonstrates also the reliability and safety of this care through the use of closure systems as shown by Albert. Now, it seems judicious to develop and improve this care since the use of smaller diameter devices would tend to render manual compression sufficient.

The method used is based on our previous protocols, routine practice and evaluation. First of all, patients eligible for same-day discharge are first selected according to SFAR (Société Française d'Anesthésie Réanimation - French Society for Anesthesia and Resuscitation) criteria for outpatients. Patients failing to meet these criteria are directed towards conventional hospitalization.

For outpatients, the patients are hospitalized in a specific unit hosting outpatients of different medico-surgical specialties. The paramedical team checks the prerequisites and the preoperative assessment. The use of a common femoral approach with 5F sheath is required. According to patients' needs, femoral anterograde or retrograde puncture are performed under duplex scan guidance. Aortoiliac and infrainguinal occlusive lesions are indifferently treated but the endovascular treatment must be compatible with the use of a stent or a drug coating balloon 5F sheath and 0.035 compatible..

The procedure should be finished 5h prior the outpatients unit closing to allow 5h follow-up. The intervention proceeded after an intravenous bolus of heparin. Anesthesia, antiplatelet regimen were let at the discretion of the interventionnalist. End-of-procedure hemostasis shall be implemented by the operator by manual compression for at least 10 minutes, potentially extended until complete hemostasis is achieved. A pressure pad shall be applied just after the end of manual compression.

The patient's general and local condition shall be monitored in the recovery room. If there are no local or general complications, the patient shall return to the ambulatory unit. In the unit, at H4, the compressive dressing is removed, patient is place in half-sitting position and without any complications, the ability to be discharged will be evaluated. The day after the operation, the patient is contacted by the ambulatory unit according with HAS and SFAR recommandations for a medical checkpoint. All of this will be conducted under medical and paramedical supervision. In the event of femoral puncture site active bleeding at any stage during care, the patient's surgeon will be notified and an additional manual compression will be applied if necessary. There are no specific guidelines concerning treatment with platelet aggregation inhibitors, whose choice will be left to the operator's discretion. In all cases, the treatments will be recorded.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Feasibility of Outpatient Care After Manual Compression in Patients Treated for Peripheral Arterial Disease by Endovascular Technique With 5F Sheath Femoral Approach
Actual Study Start Date : September 28, 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : July 2018

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. Total in-hospital admission rate [ Time Frame: 1 month ]
    Total in-hospital admission rate includes unplanned overnight surveillance and re-hospitalization rate at 1 month.


Secondary Outcome Measures :
  1. Death (all causes) at 1 month. [ Time Frame: 1 month ]
  2. Unplanned overnight surveillance rate [ Time Frame: 1 month ]
  3. Re-hospitalization after discharge during M1 [ Time Frame: 1 month ]
  4. Occurrence of major events during the perioperative period (H0 to M1) [ Time Frame: 1 month ]
    Occurrence of major events during the perioperative period (H0 to M1) (MACE: Major Adverse Cardiovascular Event, MALE: Major Adverse Limb Event)

  5. Occurrence of major punctured femoral artery events during the perioperative period (H0 to M1) [ Time Frame: 1 month ]
    Occurrence of major punctured femoral artery events during the perioperative period (H0 to M1), requiring prolongation of hospitalization, repeat hospitalization or repeat surgery (hematoma, hemorrhage, false aneurysm, arterio-venous fistula, infection…).

  6. Occurrence of minor punctured femoral artery events during the perioperative period (H0 to M1), not requiring prolongation of hospitalization, repeat hospitalization or repeat surgery [ Time Frame: 1 month ]
  7. Technical success which is defined successful vascular access and completion of the endovascular procedure and immediate morphological success with less than 30% residual diameter reduction of the treated lesion on completion angiography. [ Time Frame: 1 month ]
  8. Time for groin compression and dressing. [ Time Frame: 1 month ]
  9. Freedom from target lesion revascularization (TLR) at 1 month. [ Time Frame: 1 month ]
    TLR expresses the frequency of the need for repeated procedures (endovascular or surgical) due to a problem arising from the treated lesion in surviving patients with preserved limb.

  10. Freedom from target extremity revascularization (TER) at 1 month. TER is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target limb in surviving patients with preserved limb. [ Time Frame: 1 month ]
  11. Clinical success at 1 month. [ Time Frame: 1 month ]
    Clinical success is defined by defined as a sustained upward shift of 1 category of the Rutherford classification for claudicants and by wound healing and rest pain resolution for patients in CLI, without the need for repeated TLR in surviving patients.

  12. Haemodynamic improvement: of ABI-values with 0.10 as compared to baseline values or to ABI inferior or egal 0.9 at 1-month without need for repeated TLR in surviving patients. [ Time Frame: 1 month ]
  13. Quality of life evaluation (EQ5D-3L) at 1 month. [ Time Frame: 1 month ]
  14. Economic analysis endpoints [ Time Frame: 1 month ]
    Resources consumed will be recorded from the intervention to one month post-operatively. We will collect hospital resources consumed (length of procedures, operative room staff, medical device used in case of manual compression's failure, hospitalizations due to complications…) and office-based care resources (medical and paramedical consultations, caregivers).



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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 treatment by stent or drug coating balloon 5F and 0.035 compatible
  • Femoral approach
  • Outpatient hospitalization
  • Manual compression at puncture site
  • Rutherford 2 to 5
  • Patient affiliated with a social security scheme
  • Patient's signed informed consent form

Exclusion Criteria:

  • Under-age patient
  • Patient of age, but under legal guardianship or care
  • Contraindication to endovascular treatment
  • Use of a 6F or greater sheath
  • Radial or brachial puncture
  • Acute ischemia
  • Anticoagulant treatment or hemostasis disorder
  • Allergy to Elastoplast® type adhesive strips
  • Life expectancy of less than one month
  • Refusal of patient to participate in the study
  • Participation in another therapeutic trial
  • Pregnant woman, lactating women
  • Patients do not understand the French language or unfit for proposed follow in 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): NCT03185052


Contacts
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Contact: Yann GOUEFFIC, Professor (33) 2 40 16 50 93 yann.goueffic@chu-nantes.fr

Locations
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France
CHU de Besançon Not yet recruiting
Besançon, France
Contact: Simon RINCKENBACH, Professor         
Principal Investigator: Simon RINCKENBACH         
CHU de Bordeaux Not yet recruiting
Bordeaux, France
Contact: Eric DUCASSE, Professor         
Principal Investigator: Eric DUCASSE         
AP-HP, Hôpital Ambroise Paré Not yet recruiting
Boulogne-Billancourt, France
Contact: Raphael COSCAS, Doctor         
Principal Investigator: Raphael COSCAS         
CHU de Clermont Ferrand Not yet recruiting
Clermont-Ferrand, France
Contact: Eugenio ROSSET, Professor         
Principal Investigator: Eugenio ROSSET         
CHU de DIJON Not yet recruiting
Dijon, France
Contact: Eric STEINMETZ, Professor         
Principal Investigator: Eric STEINMETZ         
Clinique de Fontaine-Les- Dijon Not yet recruiting
Dijon, France
Contact: Jean-Luc PIN, Doctor         
Principal Investigator: Jean-Luc PIN         
Nantes University Hospital Recruiting
Nantes, France
Contact: Yann GOUEFFIC, Professor       yann.goueffic@chu-nantes.fr   
Principal Investigator: Yann GOUEFFIC         
AP-HP, Hôpital Européen Georges Pompidou Not yet recruiting
Paris, France
Contact: Jean-Marc ALSAC, Doctor         
Principal Investigator: Jean-Marc ALSAC         
Institut Mutualiste Montsouris Recruiting
Paris, France
Contact: Alexandros MALLIOS, Doctor         
Principal Investigator: Alexandros MALLIOS         
Clinique de l'Europe Recruiting
Rouen, France
Contact: Jean SABATIER, Doctor         
Principal Investigator: Jean SABATIER         
Sponsors and Collaborators
Nantes University Hospital

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03185052     History of Changes
Other Study ID Numbers: RC16_0384
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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