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53 active trials for Critical Limb Ischemia

Evaluation of the Tissue Genesis® Icellator Cell Isolation System™ to Treat Critical Limb Ischemia

The purpose of this study is to determine the safety and effectiveness of the Tissue Genesis® Icellator Cell Isolation System™ in Critical Limb Ischemia. The Icellator System™ device removes certain cells from the adipose (fat) tissue which will be used to treat patients with blockages in the arteries of their lower legs that may require a future amputation, which is caused by severe peripheral artery disease (PAD). The purpose of this study is to determine if treatment with cells that have been removed from the Icellator System™ device will reduce the number of major amputations and deaths in a six month time period.

Start: August 2014

The DES BTK Vascular Stent System vs PTA in Subjects With Critical Limb Ischemia

Two phased global, prospective, multicenter clinical trial designed to demonstrate a superior patency rate and acceptable safety in below the knee arteries with lesions treated with the DES BTK Vascular Stent System vs. percutaneous transluminal angioplasty (PTA).

Start: August 2018

Critical Limb Ischemia and Transcutaneous Oximetry

Retrospective analysis of transcutanesou oximetry (Tcpo2) recording for patients referred with suspected critical limb ischemia searching for specific changes in TcpO2 patterns.

Start: October 2018

Nutrition in Patient With Critical Limb Ischemia

A prospective pilot study examining nutritional supplements among vascular surgery patients with Critical Limb Ischemia (CLI). CLI patients have a high rate of malnutrition and has the potential to benefit greatly from nutritional intervention. The investigators plan to evaluate nutrition and functional status of patients by assessing objective lab values and the use of the hand grip strength test. Providing perioperative nutritional supplements to patients has potentially improved their nutritional status, which in turn may improve the patient's clinical status after surgery.

Start: October 2018

Prospective Cohort of Patients With Critical Limb Ischemia Undergoing Revascularization

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.

Start: May 2021

Foot Perfusion Analysis to Predict Limb Salvage

This study aims at evaluating the correlation between foot perfusion on angiographies performed before and after revascularization and limb salvage in patients with critical limb ischemia.

Start: February 2019

Efficacy and Safety of Apixaban in Reducing Restenosis and Limb Loss in PAD Patients.

This study will evaluate the efficacy and safety of apixaban 2.5 mg twice daily plus aspirin compared to the standard treatment (clopidogrel plus aspirin) in patients with critical limb ischemia undergoing infrapopliteal arterial endovascular intervention.

Start: January 2020

YQ23 Study in Patients With Critical Limb Ischaemia

This is an early phase study to assess how safe and tolerable is the new study drug YQ23 and to compare the effectiveness of YQ23 against normal saline to treat critical limb ischaemia. The study also aims to understand how it affects the body and an optional substudy to assess how the human body takes up, breaks down, and clears the study drug. Eligible patients will be randomised to have a 2:1 chance to receive a single, intravenous, fixed dose of YQ23 or normal saline. Neither the patient nor the study site will know which treatment has been given. On the day of YQ23 administration, patients will be asked to stay in the study site for 3 days for safety observation. After discharge, they will be required to visit the study clinic for 3 times in a year to continue safety monitoring and assessment of treatment effect. Each subject's participation will be about 13 months after signing the informed consent.

Start: March 2021

Intima Versus Adventitia Drug Delivery to Elucidate Mechanisms of Restenosis: Magnetic Resonance Imaging

This is a prospective, multicenter, randomized trial to determine the mechanisms of vascular healing. The study will evaluate subjects with peripheral artery disease (PAD) who require an endovascular intervention of the femoro-popliteal (SFA) artery to restore blood flow to the leg.

Start: February 2016

Abbott Vascular Medical Device Registry

The AV-MDR is a prospective, non-randomized, open-label, multi-center registry. The purpose of the AV-MDR study is to proactively collect and evaluate clinical data on the usage of the devices in scope within their intended use with the aim of confirming safety and performance throughout their expected lifetime, ensuring the continued acceptability of identified risks, detecting emerging risks on the basis of factual evidence, ensuring the continued acceptability of the benefit-risk ratio, and identifying possible systematic misuse or off-label usage such that the intended use can be verified as appropriate.

Start: October 2020

Cardiovascular Clinical Project to Evaluate the Regenerative Capacity of CardioCell in Patients With No-option Critical Limb Ischemia (N-O CLI)

The main objective of the CIRCULATE project is to compare the clinical outcomes of CardioCell administration in treatment of ischemic damages of cardiovascular system with control group, who will be treated by the administration of placebo during the sham procedure.

Start: April 2018

Lutonix DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries

To assess the safety and efficacy of the Lutonix Drug Coated Balloon (DCB) for treatment of stenosis or occlusion of native below-the-knee arteries.

Start: June 2013

SCOPE CLI (Shifting Care and Outcomes for Patients With Endangered Limbs - Critical Limb Ischemia)

Given the importance of understanding CLI patients' outcomes and existing gaps in knowledge, there is a pressing need to collect observational data on treatment patterns, adherence to performance measures, and outcomes that are relevant to patients and clinicians. To address this need, the current study will pilot test the research infrastructure and data elements needed to build a larger, national study collecting of the CLI population. It will also provide much-needed preliminary information to identify areas of action that can be targeted in quality improvement programs for this population. Most importantly, it will provide data on health status outcomes in patients with CLI, as a function of individual patient characteristics (demographics, socio-economic and clinical background) and the treatments that patients have undergone. The PORTRAIT-CLI study will also be well equipped to identify potential disparities in the provision of care and patients' outcomes as a function of patient's characteristics.

Start: January 2020

Additional Hyperbaric Oxygen After Lower Extremity Amputation

This study evaluates the effect of additional hyperbaric oxygen therapy after lower extremity amputation. The patients will be randomized after amputation to either a treatment group receiving hyperbaric oxygen therapy, or control group.

Start: July 2018

The PROMISE II Trial, Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia

The LimFlow System is intended for endovascular, minimally invasive procedures in patients who have a clinical diagnosis of chronic limb-threatening ischemia and who have been determined to have no surgical or endovascular treatment option (i.e., "no option").

Start: December 2019

Peripheral Registry of Endovascular Clinical Outcomes "The PRIME Registry"

The PRIME Registry is a multi-center, observational study designed to evaluate immediate and long-term outcomes (36 months) of endovascular revascularization in patients with critical limb ischemia (CLI) and advanced peripheral artery disease (PAD).

Start: January 2013

BEST vCLI Registry

For subjects with critical limb ischemia, identify patient, physician/hospital, and geographic factors associated with variations in treatment strategies; compare treatments and outcomes, including quality of life, cost and cost effectiveness, at 6, 12 months.

Start: December 2019

Drug-Eluting Balloon Angioplasty Versus Bypass Surgery as First-Line Strategies in Infrageniculate Arterial Disease for Critical Limb Ischemia in Type 2 Diabetic Pacients: a Randomised Controlled Clinical Trial

The aim of this study is to evaluate the outcomes of drug-eluting balloon angioplasty and vein bypass surgery in diabetic patients with critical limb ischemia due to infrapopliteal arterial disease.

Start: March 2020

A Study of the TEmporary Spur StEnt System for the Treatment of Lesions Located in the InfraPoplitEal ARteries Using a LIMUS-base DCB

This is a non-randomized, prospective, single center pilot study designed to evaluate the safety of the Temporary Spur Stent System to treat patients with infrapopliteal arterial disease, when used in conjunction with a commercially available limus-base drug coated balloon.

Start: February 2020

Autologous Fat Grafting in the Treatment of Critical Limb Ischaemia

Critical Limb Ischaemia (CLI) is a condition characterized by chronic ischemic at-rest pain, ulcers, or gangrene for more than 2 weeks in one or both legs, attributable to objectively proven arterial occlusive disease.CLI is associated with a high risk of lower amputation, diminished quality of life and mortality. Revascularization by either bypass surgery or endovascular recanalization is considered the first-choice treatment in patients with CLI. Revascularization is not always possible because patients with CLI often have severe comorbidities or because it is not technically feasible. On the basis of their well-recognized regenerative and angiogenetic properties, cell therapy with autologous bone marrow-derived mesenchymal stem cells (BMMSCs) has been proposed and tested in different animal models and in some human pathological conditions characterized by peripheral ischemia and wound formation.

Start: January 2021