Cohort Study of Patients Treated for Peripheral Arterial Occlusive Disease

Peripheral Arterial Obstructive Disease Clinical Trial

— EndoRevI  

Official title:

Cohort Study of Patients Treated for Peripheral Arterial Occlusive Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04114838
• Other study ID #: EndoRevI
• Status: Completed
• Start date: January 2, 2020
• Est. completion date: May 6, 2022

Study information

• Verified date: May 2022
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: May 6, 2022
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Peripheral Arterial Obstructive Disease

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint-Joseph	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

References & Publications (1)

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 is — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate without major amputation	The outcome measure the survival rate without major amputation at 1 year.	year 1
Secondary	Prevalence of Intraoperative Deaths and Cardiovascular Events	This measures the prevalence of Intraoperative Deaths and Cardiovascular Events.	Day 1
Secondary	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
Secondary	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
Secondary	Healing rate	This outcome measure the healing rate, 1 year after the surgery.	Year 1