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

Peripheral Arterial Disease Clinical Trial

— ABALONE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05756491
• Other study ID #: 2022-A01201-42
• Status: Recruiting
• Phase: N/A
• Start date: April 11, 2023
• Est. completion date: April 11, 2026

Study information

• Verified date: January 2024
• Source: Fondation Hôpital Saint-Joseph
• Contact: Yann GOUEFFIC
• Phone: +33 (0)1 44 12 75 91
• Email: ygoueffic[@]ghpsj.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: April 11, 2026
• Est. primary completion date: April 11, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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)
• 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)
• 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)
• 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

Country	Name	City	State
France	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 Privé SAINT GREGOIRE	Saint Gregoire
France	Centre Hospitalier Yves Le Foll-	Saint-Brieuc
France	Clinique Esquirol-Saint-Hilaire,	Saint-Hilaire
France	Médipôle Lyon Villeurbanne,	Villeurbanne

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Hôpital Saint-Joseph

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outpatient Hospitalization Rate for Endovascular Treatment of PAD at the End of the Procedure Period		30 month
Secondary	Number of postoperative complications requiring re-hospitalization		1 month
Secondary	Functional improvement at 1 month as assessed by the Rutherford classification		1 month
Secondary	Assessment of patient anxiety using the HAS anxiety questionnaire		pre-procedure
Secondary	Assessment of patient anxiety using the HAS anxiety questionnaire		immediately after procedure
Secondary	Assessment of patient anxiety using the HAS anxiety questionnaire		Day 7