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RECRUITINGINTERVENTIONAL

Outpatient Hospitalization of Unaccompanied Patients at Home for Endovascular Treatment of Peripheral Arterial Disease.

Outpatient Hospitalization of Unaccompanied Patients at Home for Endovascular Treatment of Peripheral Arterial Disease: a Cluster Randomized Trial.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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) Who Should NOT Join This Trial: - \- 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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) Exclusion Criteria: * \- 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

Treatments Being Tested

OTHER

24 months of inclusion of unaccompanied patients

inclusion for 6 months of accompanied patients in conventional outpatient care (observational period) and then inclusion for 24 months of unaccompanied with remonte surveillance patients and accompanied patients (interventional period)

OTHER

18 months of inclusion of unaccompanied patients

inclusion for 12 months of accompanied patients in conventional outpatient care (observational period) and then inclusion for 18 months of unaccompanied with remonte surveillance patients and accompanied patients (interventional period)

OTHER

12 months of inclusion of unaccompanied patients

inclusion for 18 months of accompanied patients in conventional outpatient care (observational period) and then inclusion for 12 months of unaccompanied with remonte surveillance patients and accompanied patients (interventional period)

OTHER

6 months of inclusion of unaccompanied patients

inclusion for 24 months of accompanied patients in conventional outpatient care (observational period) and then inclusion for 6 months of unaccompanied with remonte surveillance patients and accompanied patients (interventional period)

Locations (20)

Chu Jean Minjoz
Besançon, France
Centre Hospitalier de Béziers,
Béziers, France
Hopital Universitaire Ambroise Paré,
Boulogne-Billancourt, France
CHRU Cavale Blanche
Brest, France
Chu Cote de Nacre
Caen, France
Hôpital Universitaire Gabriel Montpied
Clermont-Ferrand, France
Pôle médical du Grand large,
Décines-Charpieu, France
Hopital Le Bocage,
Dijon, France
Hopital Prive Dijon Bourgogne
Dijon, France
Clinique Mutualiste Porte de L'Orient
Lorient, France
Chu de Nantes
Nantes, France
Hopital Prive Du Confluent
Nantes, France
Chu de Nice,
Nice, France
Hôpital Saint Joseph
Paris, France
Polyclinique Francheville,
Périgueux, France
Clinique de L'Europe
Rouen, France
Centre Hospitalier Yves Le Foll-
Saint-Brieuc, France
Centre Hospitalier Privé SAINT GREGOIRE
Saint-Grégoire, France
Clinique Esquirol-Saint-Hilaire,
Saint-Hilaire, France
Médipôle Lyon Villeurbanne,
Villeurbanne, France