Status:
RECRUITING
Outpatient Hospitalization of Unaccompanied Patients at Home for Endovascular Treatment of Peripheral Arterial Disease.
Lead Sponsor:
Fondation Hôpital Saint-Joseph
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 populat...
Eligibility Criteria
Inclusion
- 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
- \- 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
Key Trial Info
Start Date :
April 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 11 2026
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT05756491
Start Date
April 11 2023
End Date
April 11 2026
Last Update
January 16 2024
Active Locations (20)
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1
Chu Jean Minjoz
Besançon, France, 25030
2
Centre Hospitalier de Béziers,
Béziers, France, 34500
3
Hopital Universitaire Ambroise Paré,
Boulogne-Billancourt, France, 92100
4
CHRU Cavale Blanche
Brest, France, 29200