Clinical trial NCT04114838: Cohort Study of Patients Treated for Peripheral Arterial Occlusive Disease
Official title: Cohort Study of Patients Treated for Peripheral Arterial Occlusive Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Obstructive Disease
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2019-10-03
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients were hospitalized the vascular medicine department of the Hospital Group Paris Saint-Joseph, for management of an PAOD with endovascular revascularization, between November 1, 2013 and September 2018.

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 retrospective study is to evaluate the life-threatening, limb salvage and associated prognostic factors in patients with Peripheral Arterial Occlusive Disease supported by endovascular revascularization in the vascular medicine department of the GHPSJ.


Eligibility criteria: Inclusion Criteria:

* Patient whose age ≥ 18 years
* Patient with intermittent / intermittent claudication / arterial ulcer / mixed ulcer / critical ischemia / acute ischemia, whose need for a revascularization procedure in the patient's medical management was discussed and confirmed as a multidisciplinary staff between 1st November 2013 and September 2018
* endovascular revascularized Patient
* Francophone patients

Exclusion Criteria:

* Patients under guardianship or curatorship
* Patients deprived of their liberty
* Patients who oppose 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 and Cardiovascular Events
timeFrame: Day 1
measure: Prevalence of Deaths and Cardiovascular Events, at 1 month
timeFrame: Month 1
measure: Prevalence of Deaths and 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:
citation: Yannoutsos A, Lin F, Billuart O, Gaisset R, Sacco E, Beaussier H, Buronfosse A, Mourad JJ, Emmerich J, Lazareth I, Priollet P. Predictive value of admission blood pressure for 3-month mortality in patients undergoing revascularization for critical limb ischemia. J Hypertens. 2020 Dec;38(12):2409-2415. doi: 10.1097/HJH.0000000000002556.