Peripheral Arterial DiseaseABALONENCT05756491
Outpatient Hospitalization of Unaccompanied Patients at Home for Endovascular Treatment of Peripheral Arterial Disease.
A study testing 24 months of inclusion of unaccompanied patients, 18 months of inclusion of unaccompanied patients and 12 months of inclusion of unaccompanied patients in people with Peripheral Arterial Disease, run by Fondation Hôpital Saint-Joseph at 20 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- 24 months of inclusion of unaccompanied patients, 18 months of inclusion of unaccompanied patients and 12 months of inclusion of unaccompanied patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 20 sitesFrance
- Study dates
- 11 Apr 2023to 11 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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 cannot join
- - 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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
France20 sites, 20 recruiting
- Recruiting
Chu Jean Minjoz
Besançon, 25030
Simon Rinckenbach
- Recruiting
Centre Hospitalier de Béziers,
Béziers, 34500
Sebastien Cazaban
- Recruiting
Hopital Universitaire Ambroise Paré,
Boulogne-Billancourt, 92100
Raphael Coscas
- Recruiting
CHRU Cavale Blanche
Brest, 29200
Bahaa Nasr
- Recruiting
Chu Cote de Nacre
Caen, 14000
Ludovic Berger
- Recruiting
Hôpital Universitaire Gabriel Montpied
Clermont-Ferrand, 63003
Fabien THAVEAU
- Recruiting
Pôle médical du Grand large,
Décines-Charpieu, 69150
Bertrand Edé
- Recruiting
Hopital Le Bocage,
Dijon, 21000
Eric Steinmetz
- Recruiting
Hopital Prive Dijon Bourgogne
Dijon, 21000
Jean Luc Pin
- Recruiting
Clinique Mutualiste Porte de L'Orient
Lorient, 56324
Jean Baptiste BOCQUEL
- Recruiting
Chu de Nantes
Nantes, 44000
Blandine Maurel
- Recruiting
Hopital Prive Du Confluent
Nantes, 44000
Stéphane BRENUGAT
- Recruiting
Chu de Nice,
Nice, 06000
Nirvana Sadaghianloo
- Recruiting
Hôpital Saint Joseph
Paris, 75014
Yann GOUEFFIC
- Recruiting
Polyclinique Francheville,
Périgueux, 24000
Nicolas Diard
- Recruiting
Clinique de L'Europe
Rouen, 76100
Jean Sabatier
- Recruiting
Centre Hospitalier Yves Le Foll-
Saint-Brieuc, 22027
Christophe Robin
- Recruiting
Centre Hospitalier Privé SAINT GREGOIRE
Saint-Grégoire, 35760
Laurent Ferté
- Recruiting
Clinique Esquirol-Saint-Hilaire,
Saint-Hilaire, 47000
Romain Belmonte
- Recruiting
Médipôle Lyon Villeurbanne,
Villeurbanne, 69100
Thibault Streichenberger
About this study
Official title: Outpatient Hospitalization of Unaccompanied Patients at Home for Endovascular Treatment of Peripheral Arterial Disease: a Cluster Randomized 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.
Read more
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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- 24 months of inclusion of unaccompanied patients, 18 months of inclusion of unaccompanied patients, 12 months of inclusion of unaccompanied patients, 6 months of inclusion of unaccompanied patients
- Keywords
- ambulatory, accompanied patient, unaccompanied patient
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24 months of inclusion of unaccompanied patientsOther
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 patientsOther
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 patientsOther
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 patientsOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Group1 | Experimental | In group 1: 5 centers will be randomized for the inclusion of unaccompanied patients for 24 months Receives: Other: 24 months of inclusion of unaccompanied patients |
| Experimental: Group2 | Experimental | In group 2: 5 other centers will be randomized for the inclusion of unaccompanied patients for 18 months Receives: Other: 18 months of inclusion of unaccompanied patients |
| Experimental: Group3 | Experimental | In group 3: 5 other centers will be randomized for the inclusion of unaccompanied patients for 12 months Receives: Other: 12 months of inclusion of unaccompanied patients |
| Experimental: Group4 | Experimental | In group 4: 5 other centers will be randomized for the inclusion of unaccompanied patients for 6 months Receives: Other: 6 months of inclusion of unaccompanied patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outpatient Hospitalization Rate for Endovascular Treatment of PAD at the End of the Procedure Period
Measured: 30 month
Secondary outcomes (5)
Number of postoperative complications requiring re-hospitalization
Measured: 1 month
Functional improvement at 1 month as assessed by the Rutherford classification
Measured: 1 month
Assessment of patient anxiety using the HAS anxiety questionnaire
Measured: pre-procedure
Assessment of patient anxiety using the HAS anxiety questionnaire
Measured: immediately after procedure
Assessment of patient anxiety using the HAS anxiety questionnaire
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start11 Apr 2023
- Primary completion11 Apr 2026 (estimated)
- Study completion11 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- standard care: accompanied patients Remote surveillance: unaccompanied patients
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756491
- Sponsor's protocol ID
- 2022-A01201-42
- Acronym
- ABALONE
- Status last verified
- Jan 2024
- First submitted
- 20 Jan 2023
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Hospitalization of Unaccompanied Patients at Home for Endovascular Treatment of Peripheral Arterial Disease: a Cluster Randomized Trial.
- ClinicalTrials.gov ID
- NCT05756491
- Acronym / sponsor ID
- ABALONE / 2022-A01201-42
- Conditions
- Peripheral Arterial Disease
- Keywords
- ambulatory, accompanied patient, unaccompanied patient
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 11 Apr 2026 (estimated)
- Study completion
- 11 Apr 2026 (estimated)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- standard care: accompanied patients Remote surveillance: unaccompanied patients
| Arm | Type | Receives |
|---|---|---|
| Experimental: Group1 | Experimental | Other: 24 months of inclusion of unaccompanied patientsIn group 1: 5 centers will be randomized for the inclusion of unaccompanied patients for 24 months |
| Experimental: Group2 | Experimental | Other: 18 months of inclusion of unaccompanied patientsIn group 2: 5 other centers will be randomized for the inclusion of unaccompanied patients for 18 months |
| Experimental: Group3 | Experimental | Other: 12 months of inclusion of unaccompanied patientsIn group 3: 5 other centers will be randomized for the inclusion of unaccompanied patients for 12 months |
| Experimental: Group4 | Experimental | Other: 6 months of inclusion of unaccompanied patientsIn group 4: 5 other centers will be randomized for the inclusion of unaccompanied patients for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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)
Key exclusion criteria (7 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 24 months of inclusion of unaccompanied patientsinclusion 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 | Experimental: Group1 |
| 18 months of inclusion of unaccompanied patientsinclusion 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 | Experimental: Group2 |
| 12 months of inclusion of unaccompanied patientsinclusion 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 | Experimental: Group3 |
| 6 months of inclusion of unaccompanied patientsinclusion 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) | Other | Experimental: Group4 |
Primary outcome
Outpatient Hospitalization Rate for Endovascular Treatment of PAD at the End of the Procedure Period
Time frame: 30 month
5 secondary outcomes
Number of postoperative complications requiring re-hospitalization
Time frame: 1 month
Functional improvement at 1 month as assessed by the Rutherford classification
Time frame: 1 month
Assessment of patient anxiety using the HAS anxiety questionnaire
Time frame: pre-procedure
Assessment of patient anxiety using the HAS anxiety questionnaire
Time frame: immediately after procedure
Assessment of patient anxiety using the HAS anxiety questionnaire
Time frame: Day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 24 months of inclusion of unaccompanied patients, 18 months of inclusion of unaccompanied patients and 12 months of inclusion of unaccompanied patients in people with Peripheral Arterial Disease, run by Fondation Hôpital Saint-Joseph at 20 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yann GOUEFFIC (+33 (0)1 44 12 75 91, ygoueffic@ghpsj.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outpatient Hospitalization Rate for Endovascular Treatment of PAD at the End of the Procedure Period (time frame: 30 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024; AzTrials last refreshed its copy on 8 Nov 2026.