Prospective Cohort of Patients With Critical Limb Ischemia Undergoing Revascularization

Critical Limb Ischemia Clinical Trial

— CLI ENDOVASC  

Official title:

Prospective Cohort of Patients With Critical Limb Ischemia Undergoing Revascularization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04312451
• Other study ID #: CLI ENDOVASC
• Status: Recruiting
• Start date: November 5, 2021
• Est. completion date: June 25, 2027

Study information

• Verified date: September 2022
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: Alexandra YANNOUTSOS, MD
• Phone: 144123568
• Email: ayannoutsos[@]hpsj.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 25, 2027
• Est. primary completion date: June 25, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Man or Woman whose age is = 18 years old

• Patient with critical lower limb ischemia defined by the existence of decubitus pain or a wound (foot ulcer or gangrene) evolving for more than 2 weeks associated 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 gesture discussed and confirmed by multidisciplinary staff

Exclusion Criteria:

• Patients under guardianship or curatorship

• Patients deprived of their liberty

• Patients objecting to the use of their data for this research

Related Conditions & MeSH terms

• Critical Limb Ischemia
• Ischemia

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 (7)

Aboyans V, Ricco JB, Bartelink MEL, Björck M, Brodmann M, Cohnert T, Collet JP, Czerny M, De Carlo M, Debus S, Espinola-Klein C, Kahan T, Kownator S, Mazzolai L, Naylor AR, Roffi M, Röther J, Sprynger M, Tendera M, Tepe G, Venermo M, Vlachopoulos C, Desor — View Citation

Criqui MH, Aboyans V. Epidemiology of peripheral artery disease. Circ Res. 2015 Apr 24;116(9):1509-26. doi: 10.1161/CIRCRESAHA.116.303849. Review. Erratum in: Circ Res. 2015 Jun 19;117(1):e12. — View Citation

Faglia E, Mantero M, Caminiti M, Caravaggi C, De Giglio R, Pritelli C, Clerici G, Fratino P, De Cata P, Dalla Paola L, Mariani G, Poli M, Settembrini PG, Sciangula L, Morabito A, Graziani L. Extensive use of peripheral angioplasty, particularly infrapopli — View Citation

Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASC II Working Group. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg. 2007 Jan;45 Suppl S:S5-67. — View Citation

Romiti M, Albers M, Brochado-Neto FC, Durazzo AE, Pereira CA, De Luccia N. Meta-analysis of infrapopliteal angioplasty for chronic critical limb ischemia. J Vasc Surg. 2008 May;47(5):975-981. doi: 10.1016/j.jvs.2008.01.005. Epub 2008 Apr 18. — View Citation

Salas CA, Adam DJ, Papavassiliou VG, London NJ. Percutaneous transluminal angioplasty for critical limb ischaemia in octogenarians and nonagenarians. Eur J Vasc Endovasc Surg. 2004 Aug;28(2):142-5. — View Citation

Savji N, Rockman CB, Skolnick AH, Guo Y, Adelman MA, Riles T, Berger JS. Association between advanced age and vascular disease in different arterial territories: a population database of over 3.6 million subjects. J Am Coll Cardiol. 2013 Apr 23;61(16):173 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate without major amputation	This outcome measure the survival rate without major amputation at 1 year.	Year 1
Secondary	Prevalence of intraoperative deaths	This outcome measures the prevalence of intraoperative deaths.	Day 1
Secondary	Prevalence of intraoperative cardiovascular events	This outcome measures the prevalence of intraoperative cardiovascular events.	Day 1
Secondary	Prevalence of intraoperative deaths, at 1 year	This outcome measures the prevalence of intraoperative deaths, at 1 year after the surgery.	Year 1
Secondary	Prevalence of intraoperative cardiovascular events, at 1 year	This outcome measures the prevalence of intraoperative cardiovascular events at 1 year after the surgery.	Year 1
Secondary	Healing rate	This outcome measures the healing rate, 1 year after the surgery.	Year 1