Feasibility of Outpatient Care After Manual Compression in Patients Treated for Peripheral Arterial Disease by Endovascular Technique With 5F Sheath Femoral Approach (FREEDOM OP)
Primary Purpose
Peripheral Arterial Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Manual puncture point compression
Sponsored by
About this trial
This is an interventional other trial for Peripheral Arterial Disease
Eligibility 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
Sites / Locations
- CHU de Besançon
- CHU de Bordeaux
- AP-HP, Hôpital Ambroise Paré
- CHU de Clermont Ferrand
- CHU de DIJON
- Clinique de Fontaine-Les- Dijon
- Nantes University Hospital
- AP-HP, Hôpital Européen Georges Pompidou
- Institut Mutualiste Montsouris
- Clinique de l'Europe
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Manual puncture point compression
Arm Description
Manual puncture point compression following a diagnostic or therapeutic procedure by endovascular technique involving retrograde femoral puncture point with 5F guide catheter
Outcomes
Primary Outcome Measures
Total in-hospital admission rate
Total in-hospital admission rate includes unplanned overnight surveillance and re-hospitalization rate at 1 month.
Secondary Outcome Measures
Death (all causes) at 1 month.
Unplanned overnight surveillance rate
Re-hospitalization after discharge during M1
Occurrence of major events during the perioperative period (H0 to M1)
Occurrence of major events during the perioperative period (H0 to M1) (MACE: Major Adverse Cardiovascular Event, MALE: Major Adverse Limb Event)
Occurrence of major punctured femoral artery events during the perioperative period (H0 to M1)
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…).
Occurrence of minor punctured femoral artery events during the perioperative period (H0 to M1), not requiring prolongation of hospitalization, repeat hospitalization or repeat surgery
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 for groin compression and dressing.
Freedom from target lesion revascularization (TLR) at 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.
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.
Clinical success at 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.
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.
Quality of life evaluation (EQ5D-3L) at 1 month.
Economic analysis endpoints
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).
Full Information
NCT ID
NCT03185052
First Posted
June 7, 2017
Last Updated
November 20, 2019
Sponsor
Nantes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03185052
Brief Title
Feasibility of Outpatient Care After Manual Compression in Patients Treated for Peripheral Arterial Disease by Endovascular Technique With 5F Sheath Femoral Approach
Acronym
FREEDOM OP
Official Title
Feasibility of Outpatient Care After Manual Compression in Patients Treated for Peripheral Arterial Disease by Endovascular Technique With 5F Sheath Femoral Approach
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
September 27, 2017 (Actual)
Primary Completion Date
October 10, 2019 (Actual)
Study Completion Date
October 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Manual puncture point compression
Arm Type
Other
Arm Description
Manual puncture point compression following a diagnostic or therapeutic procedure by endovascular technique involving retrograde femoral puncture point with 5F guide catheter
Intervention Type
Other
Intervention Name(s)
Manual puncture point compression
Intervention Description
Manual puncture point compression following a diagnostic or therapeutic procedure by endovascular technique involving retrograde femoral puncture point with 5F guide catheter
Primary Outcome Measure Information:
Title
Total in-hospital admission rate
Description
Total in-hospital admission rate includes unplanned overnight surveillance and re-hospitalization rate at 1 month.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Death (all causes) at 1 month.
Time Frame
1 month
Title
Unplanned overnight surveillance rate
Time Frame
1 month
Title
Re-hospitalization after discharge during M1
Time Frame
1 month
Title
Occurrence of major events during the perioperative period (H0 to M1)
Description
Occurrence of major events during the perioperative period (H0 to M1) (MACE: Major Adverse Cardiovascular Event, MALE: Major Adverse Limb Event)
Time Frame
1 month
Title
Occurrence of major punctured femoral artery events during the perioperative period (H0 to M1)
Description
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…).
Time Frame
1 month
Title
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
Title
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
Title
Time for groin compression and dressing.
Time Frame
1 month
Title
Freedom from target lesion revascularization (TLR) at 1 month.
Description
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.
Time Frame
1 month
Title
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
Title
Clinical success at 1 month.
Description
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.
Time Frame
1 month
Title
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
Title
Quality of life evaluation (EQ5D-3L) at 1 month.
Time Frame
1 month
Title
Economic analysis endpoints
Description
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).
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
CHU de Besançon
City
Besançon
Country
France
Facility Name
CHU de Bordeaux
City
Bordeaux
Country
France
Facility Name
AP-HP, Hôpital Ambroise Paré
City
Boulogne-Billancourt
Country
France
Facility Name
CHU de Clermont Ferrand
City
Clermont-Ferrand
Country
France
Facility Name
CHU de DIJON
City
Dijon
Country
France
Facility Name
Clinique de Fontaine-Les- Dijon
City
Dijon
Country
France
Facility Name
Nantes University Hospital
City
Nantes
Country
France
Facility Name
AP-HP, Hôpital Européen Georges Pompidou
City
Paris
Country
France
Facility Name
Institut Mutualiste Montsouris
City
Paris
Country
France
Facility Name
Clinique de l'Europe
City
Rouen
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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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
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