Cohort Study of Patients Treated for Peripheral Arterial Occlusive Disease

NCT04114838 | Completed

• 1 other identifier: EndoRevI
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Obstructive Disease

Outcome Measures

Primary Outcomes (1)

• Survival rate without major amputation

  The outcome measure the survival rate without major amputation at 1 year.

  year 1

Secondary Outcomes (4)

• Prevalence of Intraoperative Deaths and Cardiovascular Events

  Day 1

• Prevalence of Deaths and Cardiovascular Events, at 1 month

  Month 1

• Prevalence of Deaths and Cardiovascular Events, at 1 year

  Year 1

• Healing rate

  Year 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

Related 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 ischemia. J Hypertens. 2020 Dec;38(12):2409-2415. doi: 10.1097/HJH.0000000000002556.

  PMID: 32694333 RESULT

Study Officials

• Alexandra YANNOUTSOS, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 3, 2019
• Study Start: January 2, 2020
• Primary Completion: March 30, 2021
• Study Completion: May 6, 2022
• Last Updated: May 11, 2022

Record last verified: 2022-05

Locations

FR (1)