Cohort Study of Patients Treated for Peripheral Arterial Occlusive Disease (EndoRevI)

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Obstructive Disease

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Groupe Hospitalier Paris Saint-Joseph

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival rate without major amputation	The outcome measure the survival rate without major amputation at 1 year.	year 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of Intraoperative Deaths and Cardiovascular Events	This measures the prevalence of Intraoperative Deaths and Cardiovascular Events.	Day 1
Prevalence of Deaths and Cardiovascular Events, at 1 month	This measures the prevalence of Deaths and Cardiovascular Events, 1 month after the surgery.	Month 1
Prevalence of Deaths and Cardiovascular Events, at 1 year	This measures the prevalence of Deaths and Cardiovascular Events, 1 year after the surgery.	Year 1
Healing rate	This outcome measure the healing rate, 1 year after the surgery.	Year 1

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Paris Saint Joseph

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 2, 2020
• Primary Completion (ACTUAL): March 30, 2021
• Study Completion (ACTUAL): May 6, 2022

Study Registration Dates

• First Submitted: October 2, 2019
• First Submitted That Met QC Criteria: October 2, 2019
• First Posted (ACTUAL): October 3, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 11, 2022
• Last Update Submitted That Met QC Criteria: May 6, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases
• Other Study ID Numbers: EndoRevI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No