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Cohort Study of Patients Treated for Peripheral Arterial Occlusive Disease

Cohort Study of Patients Treated for Peripheral Arterial Occlusive Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04114838
Acronym
EndoRevI
Enrollment
400
Registered
2019-10-03
Start date
2020-01-02
Completion date
2022-05-06
Last updated
2022-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Obstructive Disease

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.

Interventions

None listed

Sponsors

Fondation Hôpital Saint-Joseph
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Survival rate without major amputationyear 1The outcome measure the survival rate without major amputation at 1 year.

Secondary

MeasureTime frameDescription
Prevalence of Intraoperative Deaths and Cardiovascular EventsDay 1This measures the prevalence of Intraoperative Deaths and Cardiovascular Events.
Prevalence of Deaths and Cardiovascular Events, at 1 monthMonth 1This measures the prevalence of Deaths and Cardiovascular Events, 1 month after the surgery.
Prevalence of Deaths and Cardiovascular Events, at 1 yearYear 1This measures the prevalence of Deaths and Cardiovascular Events, 1 year after the surgery.
Healing rateYear 1This outcome measure the healing rate, 1 year after the surgery.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026