Groupe Hospitalier Paris Saint-Joseph
Paris, 75014, France
Location status: Recruiting
Location contact
Alexandra YANNOUTSOS, MD
CONTACT
Helene BEAUSSIER, pharmD, pHD
CONTACT
NCT Number: NCT04312451
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Paris, 75014, France
Location status: Recruiting
Alexandra YANNOUTSOS, MD
CONTACT
Helene BEAUSSIER, pharmD, pHD
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Year 1
This outcome measure the survival rate without major amputation at 1 year.
Time frame: Day 1
This outcome measures the prevalence of intraoperative deaths.
Time frame: Day 1
This outcome measures the prevalence of intraoperative cardiovascular events.
Time frame: Year 1
This outcome measures the prevalence of intraoperative deaths, at 1 year after the surgery.
Time frame: Year 1
This outcome measures the prevalence of intraoperative cardiovascular events at 1 year after the surgery.
Time frame: Year 1
This outcome measures the healing rate, 1 year after the surgery.
Contact information is provided by the study sponsor or research team.
Fondation Hôpital Saint-Joseph
Other
Acronym: CLI ENDOVASC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06544135
Arterial Occlusive Diseases, Arteriosclerosis
Beachwood, Ohio, United States
View Trial DetailsNCT03529019
Arterial Occlusive Diseases, Arteriosclerosis
Boston, Massachusetts, United States
View Trial DetailsNCT06318767
Arterial Occlusive Diseases, Arteriosclerosis
Amiens, France
View Trial DetailsNCT04054609
Arterial Occlusive Diseases, Arteriosclerosis
Toronto, Ontario, Canada
View Trial Details