Informations générales (source: ClinicalTrials.gov)
Outpatient Hospitalization of Unaccompanied Patients at Home for Endovascular Treatment of Peripheral Arterial Disease: a Cluster Randomized Trial. (ABALONE)
Interventional
N/A
Fondation Hôpital Saint-Joseph (Voir sur ClinicalTrials)
avril 2023
avril 2026
29 juin 2024
In Westernized countries, the prevalence of peripheral arterial disease (PAD) is
estimated at 15-20% of subjects over 70 years of age and is increasing considerably
because of the aging of the population and the increasing prevalence of diabetes and
renal insufficiency. In response to this increase in incidence, vascular surgeons must
develop innovative treatments that minimize the use of resources in a context of
budgetary constraints, in patients who are increasingly well informed, while maintaining
the safety and effectiveness of the procedures performed.
The endovascular technique has several advantages. First, it is a minimally invasive
treatment, most often performed under local anesthesia. Secondly, the duration of the
procedure and the length of hospitalization are reduced. In addition, the peri-operative
morbidity and mortality is extremely low.
In France, for many years, public health policies have encouraged the development of
outpatient hospitalization. Endovascular treatment allows the development of outpatient
care. The French Society of Vascular and Endovascular Surgery (SCVE) was the first
European society to publish recommendations concerning the outpatient management of
endovascular treatment of PAD. These recommendations aim to promote the development of
outpatient treatment by providing a framework for practitioners wishing to offer this
type of management.
Concerning the patient and according to the SCVE recommendations, all types of occlusive
arterial lesions of the lower limbs can be managed on an outpatient basis and only
patients with severe comorbidities are excluded from this type of hospitalization. In
addition, various studies have shown the safety of outpatient hospitalization for PAD.
The absence of an accompanying person on the night following the procedure is considered
an exclusion criterion for outpatient care.
The objective of this Stepped-wedge Cluster Randomized Controlled Trial is to increase
the use of outpatient hospitalization for endovascular treatment of PAD by proposing a
care pathway adapted to people without an accompanying person on the night of the
procedure at home.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| GH PARIS SITE SAINT JOSEPH | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier de Béziers, - 34500 - Béziers - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Privé SAINT GREGOIRE - 35760 - Saint Gregoire - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Yves Le Foll- - 22027 - Saint-Brieuc - France | Contact (sur clinicalTrials) | ||||
| CHRU Cavale Blanche - 29200 - Brest - France | Contact (sur clinicalTrials) | ||||
| Chu Cote de Nacre - 14000 - Caen - France | Contact (sur clinicalTrials) | ||||
| Chu de Nantes - 44000 - Nantes - France | Contact (sur clinicalTrials) | ||||
| Chu de Nice, - 06000 - Nice - France | Contact (sur clinicalTrials) | ||||
| Chu Jean Minjoz - 25030 - Besançon - France | Contact (sur clinicalTrials) | ||||
| Clinique de L'Europe - 76100 - Rouen - France | Contact (sur clinicalTrials) | ||||
| Clinique Esquirol-Saint-Hilaire, - 47000 - Saint-Hilaire - France | Contact (sur clinicalTrials) | ||||
| Clinique Mutualiste Porte de L'Orient - 56324 - Lorient - France | Contact (sur clinicalTrials) | ||||
| Hopital Le Bocage, - 21000 - Dijon - France | Contact (sur clinicalTrials) | ||||
| Hopital Prive Dijon Bourgogne - 21000 - Dijon - France | Contact (sur clinicalTrials) | ||||
| Hopital Prive Du Confluent - 44000 - Nantes - France | Contact (sur clinicalTrials) | ||||
| Hopital Universitaire Ambroise Paré, - 92100 - Boulogne Billancourt - France | Contact (sur clinicalTrials) | ||||
| Hôpital Universitaire Gabriel Montpied - 63003 - Clermont-Ferrand - France | Contact (sur clinicalTrials) | ||||
| Médipôle Lyon Villeurbanne, - 69100 - Villeurbanne - France | Contact (sur clinicalTrials) | ||||
| Pôle médical du Grand large, - 69150 - Décines-Charpieu - France | Contact (sur clinicalTrials) | ||||
| Polyclinique Francheville, - 24000 - Périgueux - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- For all patients, the inclusion criteria are:
- Patient with symptomatic PAD (Rutherford 1-5) requiring endovascular
revascularization that can be performed on an outpatient basis
- Procedure listed in the Common Classification of Medical Procedures
- Patient with a good understanding of the constraints of the study
- Patient with an ASA score of 1 to 3 (stable)
- Patient registered with the social security system
- Patient living less than 1 hour by car from the care facility or from a care
facility able to care for this type of patient
- Patient willing to remain hospitalized if necessary
For accompanied patients only:
- Patient does not object to the processing of his or her data
Only for isolated patients:
- Patient with free, informed and written consent
- Patient agreeing to wear the remote monitoring device at discharge from the
outpatient revascularization hospitalization
- Patient agreeing to the processing of his or her personal data with the remote
monitoring provider
- Patient not living in an area not served by a cell phone network (white zone)
- For all patients, the inclusion criteria are:
- Patient with symptomatic PAD (Rutherford 1-5) requiring endovascular
revascularization that can be performed on an outpatient basis
- Procedure listed in the Common Classification of Medical Procedures
- Patient with a good understanding of the constraints of the study
- Patient with an ASA score of 1 to 3 (stable)
- Patient registered with the social security system
- Patient living less than 1 hour by car from the care facility or from a care
facility able to care for this type of patient
- Patient willing to remain hospitalized if necessary
For accompanied patients only:
- Patient does not object to the processing of his or her data
Only for isolated patients:
- Patient with free, informed and written consent
- Patient agreeing to wear the remote monitoring device at discharge from the
outpatient revascularization hospitalization
- Patient agreeing to the processing of his or her personal data with the remote
monitoring provider
- Patient not living in an area not served by a cell phone network (white zone)
-
- Disorders of hemostasis
- Acute ischemia of the lower limbs
- Patient already included in ABALONE (2nd inclusion impossible)
- Patient already included in a type 1 interventional research protocol
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under legal protection