Clinical trials: Critical Ischemia Limb
Peripheral Artery Disease (PAD), Chronic Limb Threatening Ischemia
Angioplasty With Shockwave IVL Catheter System in Femoropopliteal Lesions
There is a lack of prospective observational studies of shockwave balloons in the treatment of moderate-to-severe calcification of the femoral popliteal artery at the international level.
- Trial name
- SHIELD (NCT06713850)
- Testing
- Shockwave balloons
- Where
- China
- Volunteers
- 130 people
- Sponsor
- Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
Peripheral Arterial Disease, Rutherford 4 and 5 With Possibility to Improve Vascularization
Exercise Therapy With Risk Factor Management and Life Style Coaching After Vascular Intervention for Patients With Peripheral Arterial Disease
Patients with peripheral arterial disease with symptoms of critical ischemia or reduced tissue loss have a very high mortality and morbidity rate.
- Trial name
- PEARL (NCT02110251)
- Testing
- Supervised Exercise Therapy
- Where
- 2 sites in Netherlands
- Volunteers
- 14 people
- Sponsor
- Catharina Ziekenhuis Eindhoven
Diabetic Foot, Gangrene; Limb
MetaMet: Bone Cutter Versus Bone Saw for Ray Amputation
Toe amputation is a commonly performed operation for infection and/or ischaemia (tissue death due to lack of blood flow). However, a large number of patients having this surgery ultimately require further amputation due to poor…
- Conditions
- Diabetic Foot, Gangrene; Limb, Wound Infection, Wound Healing Delayed
- Trial name
- MetaMet (NCT05804565)
- Testing
- Bone Saw, Bone Cutter
- Where
- Ireland
- Volunteers
- 40 people
- Sponsor
- University College Hospital Galway
Critical Limb Ischemia, Peripheral Arterial Disease
Pilot Safety Study of Injectable SIS for Critical Limb Ischemia
This study is intended to collect safety and effectiveness data on the Cook Injectable Small Intestinal Submucosa (SIS)
- Conditions
- Critical Limb Ischemia, Peripheral Arterial Disease, Peripheral Vascular Disease
- Trial name
- CLIC (NCT02145845)
- Testing
- Injectable SIS
- Where
- Czechia
- Volunteers
- 13 people
- Sponsor
- Cook Group Incorporated
Arterial Occlusive Diseases
Feasability Study of Autologous Bone Marrow Aspirate Concentrate for Treatment of CLI
The purpose of this study is to determine if concentrated nucleated cells from your own bone marrow, injected or infused into an ischemic limb, will restore sufficient blood flow to avoid amputation.
- Trial name
- NCT00595257
- Testing
- centrifuge, laboratory, tabletop (SmartPReP2 BMAC System)
- Where
- India
- Volunteers
- 60 people
- Sponsor
- Harvest Technologies
Peripheral Arterial Disease, Critical Lower Limb Ischemia
An All-Comers Observational Study of the MicroStent™ Peripheral Vascular Stent System in Subjects With Peripheral Arterial Disease
Non-randomized, multicenter, combined prospective and retrospective cohort analysis consisting of a single arm treated with the MicroStent™ System.
- Trial name
- HEAL (NCT04110327)
- Testing
- MicroStent
- Where
- 10 sites in Austria, Belgium and 3 more
- Volunteers
- 300 people
- Sponsor
- Micro Medical Solution, Inc.
Peripheral Arterial Disease
Peripheral Microvascular Resistance as a Predictor for Limb Salvage
Salvaging a threatened limb is the key therapeutic objective for patients with critical limb ischemia, and the achievement of limb salvage is an independent predictor of patient morbidity and mortality.
- Trial name
- NCT06014242
- Testing
- Peripheral vascular flow reserve measurement
- Sponsor
- Hackensack Meridian Health
Peripheral Arterial Disease
A ProspeCtive mUlticenteR Investigation on RENzar Stent Safety and Efficacy in the Treatment of Patients With Femoro-popliteal Disease in Tuscany (CURRENT Registry)
CURRENT Registry is a physician-initiated prospective, multicenter, post-market, single-arm study with a plan to include approximately 100 patients eligible to be treated with RenzanTM Peripheral Stent System.
- Trial name
- CURRENT (NCT05701293)
- Testing
- Endovascular implantation of Renzan Stent
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Azienda Ospedaliera Universitaria Senese
Chronic Critical Limb Ischemia, Peripheral Vascular Diseases
Study to Evaluate the Safety & Performance of the Xpert(TM) Stent in Treating Below-the-knee Lesions in Patients Undergoing Percutaneous Intervention for Chronic CLI.
The purpose of this study is to evaluate the safety and performance of the Xpert(TM) self-expanding stent in infrapopliteal lesions as part of an overall treatment strategy in patients undergoing percutaneous intervention for the…
- Trial name
- XCELL (NCT00515346)
- Testing
- Xpert(TM) Self-expanding Transhepatic Biliary Stent System feasibility in treating chronic critical limb ischemia
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- VIVA Physicians
Peripheral Arterial Disease, Arterial Occlusive Diseases
Drug Eluting Balloon Angioplasty Versus Nitinol Stent Implantation in the Superficial Femoral Artery
The purpose of this study is to evaluate whether the results of drug eluting balloon are non-inferior to the Nitinol stent implantation in the femoropopliteal segment.
- Conditions
- Peripheral Arterial Disease, Arterial Occlusive Diseases, Atherosclerosis, Arteriosclerosis
- Trial name
- PAVENST (NCT02212470)
- Testing
- Drug Eluting Balloon Angioplasty, Nitinol stenting
- Where
- Brazil
- Volunteers
- 85 people
- Sponsor
- Instituto Dante Pazzanese de Cardiologia
Autologous Transplantation, Diabetic Foot
Comparison of Autologous Mesenchymal Stem Cells and Mononuclear Cells on Diabetic Critical Limb Ischemia and Foot Ulcer
Objective: To compare the effect and safety of autologous transplantation of bone marrow mesenchymal stem cells(MSCs) and mononuclear cells(MNCs) on Diabetic patients with Critical Limb Ischemia and Foot Ulcer.
- Trial name
- NCT00955669
- Testing
- Symptoms and Objective Examination
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Third Military Medical University
Critical Limb Ischemia (CLI), Diabetic Foot
Intraarterial Infusion of Autologous Bone Marrow in Diabetic Patients With Chronic Ischemia of Lower Limbs (CLI) no Revascularization
The aim of the study is to evaluate the safety and feasibility of autologous bone marrow mononuclear cells autologous administered intra-arterially in the affected limb of diabetic patients with chronic critical ischemia of the…
- Trial name
- NCT00987363
- Testing
- Intraarterial infusion of autologous bone marrow cells
- Where
- 5 sites in Spain
- Volunteers
- 60 people
- Sponsor
- Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Peripheral Vascular Disease
Efficacy/Safety of Ecraprost in Lipid Emulsion for Treatment of Critical Leg Ischemia Due to Peripheral Arterial Disease
Ecraprost in lipid emulsion is being developed for the treatment of Critical leg ischemia (CLI), which is the most severe form of peripheral arterial disease (PAD); This trial is designed to assess the efficacy and safety of the…
- Trial name
- NCT00059657
- Testing
- Ecraprost in lipid emulsion
- Where
- 22 sites in United States, United Kingdom
- Volunteers
- 280 people
- Sponsor
- Tanabe Pharma Corporation
Critical Limb Ischemia
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…
- Trial name
- NCT06174597
- Testing
- UCA-PSCs/bFGF or bFGF Intramuscular injection
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Nanjing University
CLTI Defined as Rutherford Category 4 or 5
Duration of Dual Anti-Platelet Therapy in Chronic Limb Threatening Ischemia After Distal Revascularization
Chronic limb threatening ischemia (CLTI) is defined as ischemic foot pain at rest or non-healing foot wounds that is attributable to severe peripheral arterial disease (PAD).Revascularization is the cornerstone of therapy to…
- Trial name
- DAPTCLTI (NCT07512960)
- Testing
- Clopidogrel 75 mg/day
- Where
- France
- Volunteers
- 614 people
- Sponsor
- Fondation Hôpital Saint-Joseph
Critical Limb Ischemia
Cell Therapy With Mesenchymal Stem Cell in Ischemic Limb Disease
Bone marrow MSCs will be isolated from allogenic donors, expanded under hypoxic conditions using medium containing no serum or animal-derived reagents, and applies for Phase Ⅰ/Ⅱ study in treating 18 recipients with ischemic limb…
- Trial name
- NCT02336646
- Testing
- Allogenic MSC, Normal saline
- Where
- Taiwan
- Volunteers
- 18 people
- Sponsor
- Taiwan Bio Therapeutics Inc.
Peripheral Arterial Disease, Critical Limb Ischemia
The PRELUDE BTK Study
The objective of the PRELUDE BTK study is to assess safety and efficacy of the Serranator® PTA Serration Balloon Catheter (study device) in subjects with atherosclerotic peripheral artery disease of the infrapopliteal arteries.
- Trial name
- NCT03693963
- Testing
- Serranator
- Where
- 6 sites in Austria, Germany and 2 more
- Volunteers
- 49 people
- Sponsor
- Cagent Vascular LLC
End Stage Renal Disease
Effect of Hemodialysis on Toe Pressure- and Finger Pressure and Skin Autofluorescence in Hemodialysis Patients
The aim of this study is to determine the vascular condition of hemodialysis patients with toe pressure measurement, finger pressure measurement and measuring glycated and oxidated proteins by skin autofluorescence.
- Trial name
- NCT00431314
- Volunteers
- 82 people
- Sponsor
- Isala
Atherosclerotic Ischemic Disease, Critical Limb Ischemia
Efficacy and Safety Comparison of the Open and Endovascular Surgical Methods for the Treatment of Long Atherosclerotic Lesions of the Femoral-popliteal Segment Below the Knee, TASC D in Patients With Critical Limb Ischemia
This is prospective, randomized study. The main objective of the study is to compare the clinical efficacy and safety of two therapies for the treatment of prolonged atherosclerotic lesions of the arteries of the femoropopliteal…
- Conditions
- Atherosclerotic Ischemic Disease, Critical Limb Ischemia, Superficial Femoral Artery Occlusion, Popliteal Artery Occlusion
- Trial name
- NCT04583436
- Testing
- Endovascular recanalization, Open surgery
- Where
- Russia
- Volunteers
- 90 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Critical Limb Ischemia, Severe Leg Ischemia
Phase II Combination Stem Cell Therapy for the Treatment of Severe Leg Ischemia
The purpose of this research study is to compare in patients with double-sided claudication if the transplant of a combination of stem cells obtained from the bone marrow of the same patient will contribute to the formation of…
- Conditions
- Critical Limb Ischemia, Severe Leg Ischemia, Peripheral Artery Disease, Peripheral Vascular Disease
- Trial name
- MESENDO (NCT00721006)
- Testing
- MESENDO
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- TCA Cellular Therapy