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

Last updated: January 12, 2024
Sponsor: Fondation Hôpital Saint-Joseph
Overall Status: Active - Recruiting

Phase

N/A

Condition

Claudication

Peripheral Arterial Occlusive Disease

Vascular Diseases

Treatment

18 months of inclusion of unaccompanied patients

6 months of inclusion of unaccompanied patients

12 months of inclusion of unaccompanied patients

Clinical Study ID

NCT05756491
2022-A01201-42
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • For all patients, the inclusion criteria are:

  • Patient with symptomatic PAD (Rutherford 1-5) requiring endovascular revascularizationthat 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 facilityable 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 outpatientrevascularization hospitalization

  • Patient agreeing to the processing of his or her personal data with the remotemonitoring provider

  • Patient not living in an area not served by a cell phone network (white zone)

Exclusion

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

Study Design

Total Participants: 2000
Treatment Group(s): 4
Primary Treatment: 18 months of inclusion of unaccompanied patients
Phase:
Study Start date:
April 11, 2023
Estimated Completion Date:
April 11, 2026

Connect with a study center

  • Chu Jean Minjoz

    Besançon, 25030
    France

    Active - Recruiting

  • Hopital Universitaire Ambroise Paré,

    Boulogne Billancourt, 92100
    France

    Active - Recruiting

  • CHRU Cavale Blanche

    Brest, 29200
    France

    Active - Recruiting

  • Centre Hospitalier de Béziers,

    Béziers, 34500
    France

    Active - Recruiting

  • Chu Cote de Nacre

    Caen, 14000
    France

    Active - Recruiting

  • Hôpital Universitaire Gabriel Montpied

    Clermont-Ferrand, 63003
    France

    Active - Recruiting

  • Hopital Le Bocage,

    Dijon, 21000
    France

    Active - Recruiting

  • Hopital Prive Dijon Bourgogne

    Dijon, 21000
    France

    Active - Recruiting

  • Pôle médical du Grand large,

    Décines-Charpieu, 69150
    France

    Active - Recruiting

  • Clinique Mutualiste Porte de L'Orient

    Lorient, 56324
    France

    Active - Recruiting

  • Chu de Nantes

    Nantes, 44000
    France

    Active - Recruiting

  • Hopital Prive Du Confluent

    Nantes, 44000
    France

    Active - Recruiting

  • Chu de Nice,

    Nice, 06000
    France

    Active - Recruiting

  • Hôpital Saint Joseph

    Paris, 75014
    France

    Active - Recruiting

  • Polyclinique Francheville,

    Périgueux, 24000
    France

    Active - Recruiting

  • Clinique de L'Europe

    Rouen, 76100
    France

    Active - Recruiting

  • Centre Hospitalier Privé SAINT GREGOIRE

    Saint Gregoire, 35760
    France

    Active - Recruiting

  • Centre Hospitalier Yves Le Foll-

    Saint-Brieuc, 22027
    France

    Active - Recruiting

  • Clinique Esquirol-Saint-Hilaire,

    Saint-Hilaire, 47000
    France

    Active - Recruiting

  • Médipôle Lyon Villeurbanne,

    Villeurbanne, 69100
    France

    Active - Recruiting

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