Clinical trial NCT04312451: Prospective Cohort of Patients With Critical Limb Ischemia Undergoing Revascularization
Official title: Prospective Cohort of Patients With Critical Limb Ischemia Undergoing Revascularization
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Critical Limb Ischemia
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2020-03-18
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are hospitalized in the vascular medicine department of the Paris Saint-Joseph Hospital Group, for the management of critical ischemia of the lower limbs with decision to revascularize by endovascular route for leg rescue, after discussion in multidisciplinary staff (associating vascular physicians, vascular surgeons and interventional radiologists).

Brief summary: 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.


Eligibility criteria: 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

Exclusion Criteria:

* Patients under guardianship or curatorship
* Patients deprived of their liberty
* Patients objecting to the use of their data for this research

Primary outcomes:
measure: Survival rate without major amputation
timeFrame: Year 1
Secondary outcomes:
measure: Prevalence of intraoperative deaths
timeFrame: Day 1
measure: Prevalence of intraoperative cardiovascular events
timeFrame: Day 1
measure: Prevalence of intraoperative deaths, at 1 year
timeFrame: Year 1
measure: Prevalence of intraoperative cardiovascular events, at 1 year
timeFrame: Year 1
measure: Healing rate
timeFrame: Year 1
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint-Joseph
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: Alexandra YANNOUTSOS, mD
role: PRINCIPAL_INVESTIGATOR
References:
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