NCT04066387: Pontage

Characteristics and Prognosis of Patients With Critical Ischemia at High Risk of Amputation Managed by Endovascular Bypass: a Retrospective Study of 15 Patients

Completed Last updated 3 October 2019

What this trial tests

trial in Limb Ischemia in 15 participants. Completed in 1 September 2019.

Timeline

15 May 2019

Primary endpoint
31 July 2019

1 September 2019

Quick facts

Lead sponsor	Fondation Hôpital Saint-Joseph
Status	Completed
Study type	OBSERVATIONAL
Enrollment	15
Start date	15 May 2019
Primary completion	31 July 2019
Estimated completion	1 September 2019
Sites	1 location across France

Conditions studied

• Limb Ischemia — all drugs for Limb Ischemia →

Sponsor

Fondation Hôpital Saint-Joseph — full company profile →

Who can join

18 and older, any sex, with Limb Ischemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Obliterative arterial disease of the lower limbs (AOMI) is associated with a high risk of cardiovascular events, with a linear relationship between a fall in the systolic pressure index and a risk of cardiovascular morbidity and mortality. Critical ischemia is the most severe stage of AOMI, 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, as well as the patient's vital prognosis. In these patients, the rate of amputation and mortality at 1 year can reach 20%. Consequently, the goal of management in a multidisciplinary setting is threefold: the treatment of pain, improvement of the functional prognosis and improvement of the patient's vital prognosis. Revascularization should be attempted as often as possible for the purpose of limb salvage and improvement of patient survival.

In the vascular medicine department, the indication and modalities of the revascularization procedure are discussed at a multidisciplinary consultation meeting. The medical-radiological-surgical expertise takes into consideration the patient's terrain and comorbidities and the technical possibilities according to the arterial damage. 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. foot with a lower morbidity-mortality compared to surgery, especially in 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 critical ischemia hospitalized in the vascular medicine department.

In patients with critical ischemia at high risk of major amputation and without the option of traditional endovascular or surgical revascularization, an endovascular revascularization technique for leg rescue is discussed as a last resort in multidisciplinary staff. This technique, performed by the interventional radiology team (MDP and GA), consists of an extra-anatomic endovascular femoro-popliteal bypass. We wish to describe the limb salvage rate and the preservation of autonomy in the 15 patients treated with this revascularization technique since 2013 in the vascular medicine department of the GHPSJ.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.