Actively Recruiting

Age: 18Years +
All Genders
NCT04312451

Prospective Cohort of Patients With Critical Limb Ischemia Undergoing Revascularization

Led by Fondation Hôpital Saint-Joseph · Updated on 2022-10-03

300

Participants Needed

1

Research Sites

294 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Prospective Cohort of Patients With Critical Limb Ischemia Undergoing Revascularization

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Man or woman aged 18 years or older
  • Patient with critical lower limb ischemia defined by decubitus pain or a foot wound (ulcer or gangrene) lasting more than 2 weeks 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 procedure discussed and confirmed by a multidisciplinary team
Not Eligible

You will not qualify if you...

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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Groupe Hospitalier Paris Saint-Joseph

Paris, France, 75014

Actively Recruiting

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Research Team

A

Alexandra YANNOUTSOS, MD

CONTACT

H

Helene BEAUSSIER, PharmD, pHD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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