Clinical Research Directory

Drug Eluting Temporary Spur Stent System vs Percutaneous Balloon Angioplasty for the Treatment of Critical Limb Ischemia

The purpose of this trial is to evaluate the safety and efficacy of the Drug Eluting Temporary Spur Stent System compared to PTA. The Drug Eluting Temporary Spur Stent System is intended for use as a primary treatment in the infrapopliteal arteries for the treatment of de novo or restenotic lesions.

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.

CRUSH PAD: Real-world Outcomes Following Use of Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions

The primary goal of the study is to obtain effect size data on the use of Shockwave Intravascular Lithotripsy (IVL) technology in calcified common femoral lesions in patients with peripheral artery disease for a series of endpoints, including target lesion revascularization and health status, to enable future planning of comparative effectiveness research.

Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI) Due to Peripheral Arterial Disease

The goal of this observational, practice-based feasibility study is to observe the efficacy and safety of intramuscular administration of Stempeucel® in Malaysian patients with critical limb ischemia (CLI) due to peripheral arterial disease. The main questions it aims to answer are: * Can intramuscular administration of Stempeucel® reduce symptoms of CLI due to peripheral arterial disease while improving the healing rate and functional outcomes? * Does intramuscular administration of Stempeucel® causes any serious adverse events in CLI due to peripheral arterial disease patients? Study patients will be assessed by the PI before administering the Stempeucel® for any other organ with inflammation. The study patients will also be followed up to the duration of 1 year after study treatment administration for safety and efficacy assessment.

Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI) Due to Buerger's Disease

The goal of this observational, practice-based feasibility study is to observe the efficacy and safety of intramuscular administration of Stempeucel® in Malaysian patients with critical limb ischemia (CLI) due to Buerger's disease. The main questions it aims to answer are: * Can intramuscular administration of Stempeucel® reduce symptoms of CLI due to Buerger's disease while improving the healing rate and functional outcomes? * Does intramuscular administration of Stempeucel® causes any serious adverse events in CLI due to Buerger's disease patients? Study patients will be assessed by the PI before administering the Stempeucel® for any other organ with inflammation. The study patients will also be followed up to the duration of 1 year after study treatment administration for safety and efficacy assessment.

Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee

A multicenter, randomized, double-blind, placebo-controlled trial to evaluate the effect of Temsirolimus Perivascular Injection 0.1 mg/mL on the incidence of ischemia-driven major amputation, clinically driven target lesion revascularization, and clinically relevant target lesion occlusion after revascularization of lesions below the knee in patients with symptomatic Rutherford 3-5 peripheral artery disease. The primary safety endpoint will be gathered at 1-month post-index procedure. The primary efficacy endpoint will be gathered at 6 months post-index procedure. Participants will be followed for up to 5 years post-index procedure.

Swedish Drug-elution Trial in Peripheral Arterial Disease

Peripheral arterial disease (PAD) causes reduced blood flow to the lower limb(s) due to stenosis or occlusion in the supplying arteries. Symptoms of PAD range from ischemic rest pain and/or ischemic ulcers/gangrene (critical limb ischemia), putting the extremity at risk of amputation, to exercise-induced pain (intermittent claudication), limiting the patients daily activities. Invasive treatments are often indicated to prevent amputations and to alleviate symptoms. More than two thirds of these procedures are presently performed with endovascular techniques (i.e. percutaneous transluminal angioplasty, PTA with or without stent implantation). In coronary artery disease, stents eluting anti-proliferative drugs (drug eluting stents, DES) reduce restenosis and improve clinical results for the majority of patients. Drug eluting balloons (DEB) are a promising alternative, but there is still little evidence that DES or DEB technology improve clinical outcome in PAD. However, promising results utilizing these new technologies in PAD have been reported in a few studies. In this trial, we test the hypothesis that drug eluting (DE) technology is superior to conventional endovascular treatment (no-DE) in terms of important clinical outcomes, when applied on infrainguinal (femoropopliteal and/or infrapopliteal) obstructive vascular lesions. The trial consists of 2 separate parallel studies, SWEDEPAD 1 and SWEDEPAD 2, each defined by the severity of peripheral arterial disease. Patients with critical limb ischemia are allocated to SWEDEPAD 1 and patients with intermittent claudication are allocated to SWEDEPAD 2.

Serrantor OCT Study

TA prospective randomized control trial to evaluate the serration angioplasty effect in BTK arteries with varying degrees of calcified plaque.

Use of Thermal Imaging Camera to Assess Perfusion Before and After Vascular Intervention

This is a preliminary prospective observational study measuring change in lower extremity temperature in response to revascularization procedure. The main question this study aims to answer is: \- Are temperature measurements from a forward looking infrared (FLIR) camera of the lower extremity useful in predicting outcome of revascularization procedures?

Effect of Environmental Temperature on Vascular Ultrasound Vein Scan Measurements

We wish to conduct two vascular ultrasound scans conducting vein measurements in two separate scanning rooms to assess if environmental temperature affects the vein diameter recorded.

miRNAs in Critical Limb Ischemia (miRNACLI)

For the present study, 40 patients affected by critical limb ischemia of different severity will be enrolled: patients affected by critical limb ischemia undergoing subgenual femoropopliteal bypass; patients suffering from terminal ischemia causing gangrene and therefore undergoing major amputation of the lower limb. Biopsies from the first 20 enrolled patients will be used for miRNA profiling. The total of 40 biopsies obtained from all enrolled patients will instead be used for the validation of the miRNAs identified in the profiling. The results obtained will be compared with those obtained in 40 control patients affected by infrarenal abdominal aortic aneurysm (AAA) undergoing endovascular exclusion surgery (EVAR) of the AAA without any ischemia of the lower limbs. Also in this case the biopsies of the first 20 control patients enrolled will be used for miRNA profiling. The total of 40 biopsies obtained from all control patients will instead be used for the validation of the miRNAs identified in the profiling. A total of 80 patients (40 cases and 40 controls) will be enrolled.

TP03HN106 in Patients With Critical Limb Ischemia

Critical limb ischemia (CLI) is the most severe ischemic stage in peripheral arterial disease (PAD) of the lower limbs, characterized by decreased walking ability, resting pain (lasting for more than 2 weeks), ulcers, and gangrene, which seriously affect the quality of life of patients. Some patients may even face amputation or death. Thrombosis is an important pathological feature of CLI. TP03HN106 can promote thrombolysis, thus having a therapeutic effect on CLI.

MOTIV BTK Randomized Controlled Trial

Pre-market clinical evaluation of the MOTIV Sirolimus-Eluting Bioresorbable Scaffold for the planned treatment of infrapopliteal lesions.

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.

FAZA PET/MRI in CLI Patients Pre and Post Revascularization

Peripheral artery disease is a worldwide problem, leading to high mortality and mobility. Critical limb ischemia (CLI) is associated with high risk of amputation with the subsequent decreased in life quality. Endovascular therapy is now considered the primary treatment option in these patients to improve the vascularity and prevent amputations. In recent years, development of molecular imaging tools are now become available. A recent radio tracer named 18F-Fluoroazomycin Arabinoside (FAZA) its an specific marker of hypoxia in the tissues and has been used in multiples studies. This tracer can be used in PET/MR scan providing a potentially power diagnostic tool in patients with CLI, allowing in one diagnostic study the evaluation of location and degree of hypoxia in the extremity tissues. This diagnostic tool may offer a better assessment pre and post standard of care endovascular treatment for the patients. Moreover, some of the patients treated with endovascular therapy may not have a favorable outcome, without a clear reason explaining this situation. We will try to find some predictor model in the FAZA PET/MR that can explain the different outcomes and may help clinicians choose the best treatment option in specific cases. Thirdly, post processing for optimization of the MR sequences in patients with CLI will be performed at the MR component of the PET. There would thus be great clinical interest in developing non-invasive tools that could provide more accurate diagnostic information compared to traditional tests for these patients population.

Safety, Tolerability, and Biodistribution of [89Zr]Zr-DFO-APAC in Subjects With PAOD/CLI and Healthy Volunteers (Acronyms: 89Zr = Zirconium-89, DFO = Desferrioxamine, APAC = AntiPlatelet AntiCoagulant, PET/CT = Positron Emission Tomography/Computed Tomography)

The goal of this Phase 0 clinical trial is to evaluate safety and biodistribution of \[89Zr\]Zr-DFO-APAC in patients with peripheral arterial occlusive disease / critical limb ischemia (PAOD/CLI) and healthy volunteers. The main questions it aims to answer are: * What is the safety, tolerability and pharmacokinetic profile (PK: both systemic and local vascular injury site-specific PK) of \[89Zr\]Zr-DFO-APAC? * What is the biodistribution and internal radiation dosimetry of the tracer dose of \[89Zr\]Zr-DFO-APAC? * What is the binding and retention time of \[89Zr\]Zr-DFO-APAC to arteries and atherosclerotic or microvascular lesions? Participants will receive a dose of the \[89Zr\]Zr-DFO-APAC (IMP) and PET/CT imaging is performed on days 1, 3 and 7, and follow-up visit 7-14 days post IMP dosing.

Tolerance Study of Allogeneic of Adipose Tissue Derived Mesenchymal Stroma/Stem Cells (AdMSC) Transplantation in Patients With Critical Limb Ischemia.

Critical limb ischemia (CLI) is the most severe stage of peripheral arterial disease (PAD). Cell therapy delivered to the ischemic muscle constitutes a promising approach to treat CLI patients with no or poor options of vascularization. Pre-clinical study and clinical phase I have demonstrated the safety and feasibility of the use of autologous AdMSC treatment in patients without option for revascularization CLI patients and encouraging preliminary efficacy results have been highlighted in the pilot phase. In order to optimize AdMSC quality and to accelerate treatment availability researchers decide to test the use of allogeneic cryopreserved AdMSC from healthy donor. The aim of this phase I study is to evaluate the safety of allogeneic AdMSC injection in ischemic leg.

Acceleration Time Assessment for Prediction of Critical Limb Ischemia

Critical Limb Ischaemia (CLI), the final stage of arterial disease, is a therapeutic emergency whose prognosis depends largely on the time taken to diagnose it. The growing prevalence of this condition and the associated healthcare costs make it an important public health objective. Diagnostic criteria for Critical Limb Ischaemia differ between learned societies and countries. Its diagnosis is most frequently based on the combination of a clinical criterion (ischaemic decubitus pain and/or necrotic wounds, with a time to onset \> 2 weeks) and a haemodynamic criterion (ankle systolic pressure (ASP) \< 50mmHg or toe systolic pressure (TSP) \< 30 mmHg or transcutaneous oxygen pressure (TCPO2) \< 30 mmHg). Recent studies have highlighted the importance of pulsed Doppler flow analysis in quantifying arteriopathy of the lower limbs, both by systematically analysing flow modulation and by measuring the systolic rise time of distal arteries (dorsal artery of the foot and lateral plantar artery). The main aim of this study is therefore to validate a reliable and accessible diagnostic tool for screening patients suffering from CLI so that they can be referred to a reference centre as early as possible.

Trial to Assess Chelation Therapy in Critical Limb Ischemia

TACT3a is a double blind, placebo-controlled, randomized trial to test a novel therapy, edetate disodium-based chelation of environmentally acquired toxic metals, to reduce cardiovascular events including amputation in high-risk diabetic patients.

PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia

A prospective, single-arm, multi-center study designed to gather additional information on the LimFlow System.

Safety and Preliminary Efficacy of Allogeneic Endothelial Progenitor Cells (EPCs) in Patients With Critical Limb Ischemia

The purpose of this study is to determine if allogeneic Endothelial Progenitor Cells (EPCs) intravenous infusion to a subject with leg ulcer and/or gangrene due to poor blood flow will be safe and if it will relieve leg pain, increase blood flow, and/or cure the leg wound.

Evaluation of the MAGNITUDE® Bioresorbable Drug-Eluting Scaffold in the Treatment of Patients With Below the Knee Disease in Australia

The objective of this prospective, multi-center, clinical investigation is to evaluate the MAGNITUDE BRS System for the planned treatment of narrowed infrapopliteal lesions. Up to 30 subjects will be enrolled at approximately 3 clinical sites in Australia.

Heat Therapy for Peripheral Arterial Disease (HEATPAD)

Peripheral arterial disease (PAD) is a disabling condition, with symptoms of muscle cramping or pain on exertion, which can substantially reduce quality of life. This study aims to see if AirGlove device improves participants circulation. This is phase 1 study and will be taken in 3 parts: Phase 1a will be undertaken in 10 healthy volunteers to assess the effects of the AirGlove device on lower limb arterial flow, tissue perfusion, quality of life and product usability following a single session. Phase 1b will be undertaken in 20 participants with intermittent claudication to assess the effects of the AirGlove device on lower limb arterial flow, tissue perfusion, quality of life and product usability both in a single session and following a 12-week trial of heat therapy. Phase 1c will be undertaken in 10 participants with critical limb ischaemia Rutherford stage 4 (rest pain). Lower limb arterial flow, tissue perfusion, pain scores, quality of life, and product usability will be assessed both in a single session and following a 2-12 week trial of heat therapy.

Umbilical Cord Artery-derived Perivascular Stem Cells for the Critical Limb Ischemia Therapy

This clinical trial included 2 periods. During the first period, it was a single arm study to explore the safety of umbilical cord artery-derived stem cells (UCA-PSCs) in the treatment of patients with critical limb ischemia (CLI). During the second perid, it was a single-center, randomized, controlled prospective study to determine the efficacy of the UCA-PSCs treatment. Those who had CLI were enrolled in the study.