Outpatient treatment for patients with Peripheral Arterial Disease
Outpatient Hospitalization of Unaccompanied Patients at Home for Endovascular Treatment of Peripheral Arterial Disease: a Cluster Randomized Trial.
This study tests if treating patients with Peripheral Arterial Disease in an outpatient setting is safe and effective, allowing them to go home the same day without needing to stay overnight.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondation Hôpital Saint-Joseph Academic / other |
| Locations | 20 sites (Besançon and 19 other locations) |
| Trial ID | NCT05756491 on ClinicalTrials.gov |
What this trial studies
This study focuses on the outpatient hospitalization of unaccompanied patients undergoing endovascular treatment for Peripheral Arterial Disease (PAD). It aims to evaluate the safety and effectiveness of performing these procedures in an outpatient setting, minimizing resource use while ensuring patient safety. The study includes patients with symptomatic PAD who can be treated without the need for overnight hospitalization, utilizing minimally invasive techniques. Participants will be monitored remotely after discharge to ensure their well-being.
Who should consider this trial
Good fit: Ideal candidates are patients with symptomatic PAD requiring outpatient endovascular revascularization who live within an hour's drive from the care facility.
Not a fit: Patients who require more intensive monitoring or have severe comorbidities may not benefit from this outpatient approach.
Why it matters
Potential benefit: If successful, this approach could provide patients with a more convenient and less resource-intensive treatment option for Peripheral Arterial Disease.
How similar studies have performed: Other studies have shown success with outpatient endovascular procedures, indicating that this approach is both feasible and effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Besançon and 19 other locations
- Chu Jean Minjoz — Besançon, France (Recruiting)
- Hopital Universitaire Ambroise Paré, — Boulogne Billancourt, France (Recruiting)
- CHRU Cavale Blanche — Brest, France (Recruiting)
- Centre Hospitalier de Béziers, — Béziers, France (Recruiting)
- Chu Cote de Nacre — Caen, France (Recruiting)
- Hôpital Universitaire Gabriel Montpied — Clermont-Ferrand, France (Recruiting)
- Hopital Le Bocage, — Dijon, France (Recruiting)
- Hopital Prive Dijon Bourgogne — Dijon, France (Recruiting)
- Pôle médical du Grand large, — Décines-Charpieu, France (Recruiting)
- Clinique Mutualiste Porte de L'Orient — Lorient, France (Recruiting)
- Chu de Nantes — Nantes, France (Recruiting)
- Hopital Prive Du Confluent — Nantes, France (Recruiting)
- Chu de Nice, — Nice, France (Recruiting)
- Hôpital Saint Joseph — Paris, France (Recruiting)
- Polyclinique Francheville, — Périgueux, France (Recruiting)
- Clinique de L'Europe — Rouen, France (Recruiting)
- Centre Hospitalier Privé SAINT GREGOIRE — Saint Gregoire, France (Recruiting)
- Centre Hospitalier Yves Le Foll- — Saint-Brieuc, France (Recruiting)
- Clinique Esquirol-Saint-Hilaire, — Saint-Hilaire, France (Recruiting)
- Médipôle Lyon Villeurbanne, — Villeurbanne, France (Recruiting)
Study contacts
- Study coordinator: Yann GOUEFFIC
- Email: ygoueffic@ghpsj.fr
- Phone: +33 (0)1 44 12 75 91
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.