Informations générales (source: ClinicalTrials.gov)
Prospective Cohort of Patients With Critical Limb Ischemia Undergoing Revascularization (CLI ENDOVASC)
Observational [Patient Registry]
Fondation Hôpital Saint-Joseph (Voir sur ClinicalTrials)
novembre 2021
juin 2027
29 juin 2024
Peripheral Arterial Occlusive Disease is associated with a high risk of cardiovascular
events. The critical ischemia stage represents the most severe stage of Peripheral
Arterial Occlusive Disease, associated with decubitus pain and / or foot ulceration. The
severity of this arterial involvement involves functional prognosis of the lower limb
with a high risk of amputation, and the vital prognosis of the patient. In these
patients, the rate of amputation and mortality at 1 year can reach 20%. Therefore, the
goal of management in a multidisciplinary setting is limb salvage and improvement of the
patient's vital prognosis.
In the vascular medicine department, the indication and modalities of the
revascularization procedure are discussed in a multidisciplinary consultation meeting.
Surgical revascularization by distal bypass requires venous material that can be used, a
receiving artery without diffuse lesions, in direct continuity with the arterial network
of the foot, and the absence of co-morbidities against general anesthesia. With the
modernization and development of endovascular equipment dedicated to the hamstrings, the
interventional radiology techniques in the management of critical ischemia allow the
treatment of one or more arterial axes as well as a very distal revascularization in the
arteries. of the foot with less morbidity-mortality compared to surgery, especially in
patients the most fragile patients. Since 2013, the endovascular revascularization
procedures performed by the interventional radiology team have been an integral part of
the management of patients with peripheral arterial disease of the lower limbs monitored
in the vascular medicine department. The hospital is therefore a privileged place to
observe the long-term impact of this medical care on the future of patients with
different stages of severity of arterial disease.
The objective of this prospective study is to assess the vital prognosis, limb salvage
and associated prognostic factors in patients with critical ischemia supported by
endovascular revascularization in the vascular medicine service of the GHPSJ. The
objective of this cohort study is to build a database on critical ischemia in
hospitalized patients, to judge the management, monitoring and prognosis of patients.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| GH PARIS SITE SAINT JOSEPH | Alexandra YANNOUTSOS, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Man or Woman whose age is ≥ 18 years old
- Patient with critical lower limb ischemia defined by the existence of decubitus pain
or a wound (foot ulcer or gangrene) evolving for more than 2 weeks associated with
hemodynamic criteria (systolic toe pressure <30 mm Hg and / or systolic ankle
pressure <50 mm Hg).
- Hospitalized in the vascular medicine department
- Endovascular revascularization gesture discussed and confirmed by multidisciplinary
staff
- Man or Woman whose age is ≥ 18 years old
- Patient with critical lower limb ischemia defined by the existence of decubitus pain
or a wound (foot ulcer or gangrene) evolving for more than 2 weeks associated with
hemodynamic criteria (systolic toe pressure <30 mm Hg and / or systolic ankle
pressure <50 mm Hg).
- Hospitalized in the vascular medicine department
- Endovascular revascularization gesture discussed and confirmed by multidisciplinary
staff
- Patients under guardianship or curatorship
- Patients deprived of their liberty
- Patients objecting to the use of their data for this research