Clinical trials: Critical Limb Ischemia (CLI)
Femoropopliteal Disease, Drug Coated Balloon
DCB Outcomes After Plain or Scoring Balloon for Vessel Preparation in Patients With Femoropopliteal Arterial Disease
The goal of this clinical trial is to learn if using a scoring balloon to prepare the femoropopliteal (FP) segment before drug-coated balloon treatment works better than using a regular balloon (called plain old balloon…
- Conditions
- Femoropopliteal Disease, Drug Coated Balloon, Critical Limb Ischemia (CLI), Peripheral Arterial Disease
- Trial name
- DASBAD (NCT07136883)
- Testing
- POBA, Scoring Balloon
- Where
- Spain
- Volunteers
- 83 people
- Sponsor
- Marc Sirvent
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
Critical Limb Ischemia
The Use of FlowMet-R Technology to Predict Wound Healing in CLI Patients in a Wound Care Center Setting
Single-institution, prospective nonrandomized pilot study of critical limb ischemia patients with planned lower extremity revascularization will undergo Flowmet-D measurements in a wound care center setting to determine threshold…
- Trial name
- NCT05455554
- Testing
- Flowmet-D, ABI
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Stanford University
Critical Limb Ischemia, Peripheral Arterial Disease
ALD-301 for Critical Limb Ischemia, Randomized Trial
This study will treat patients with such severe lower leg ischemia or vascular compromise that they have pain at rest. The goal is to compare treatment of the patient's painful disorder by injecting cells into the calf of the leg…
- Conditions
- Critical Limb Ischemia, Peripheral Arterial Disease, Peripheral Vascular Disease
- Trial name
- CLI-001 (NCT00392509)
- Testing
- ALDH-br bone marrow cells vs. mononuclear bone marrow cells
- Where
- 5 sites in United States
- Volunteers
- 20 people
- Sponsor
- Aldagen
Critical Limb Ischemia
Effect of Evolocumab in Patients With Critical Limb Ischemia (Evol-CLI)
Critical limb ischemia (CLI), is the most severe form of peripheral arterial disease (PAD), and clinically is characterized by pain at rest or non-healing ulcers of the lower extremities.
- Trial name
- Evol-CLI (NCT04306471)
- Testing
- Evolocumab 140mg/mL Injector 1milliliter (mL) Pen x 3 for a monthly dose of 420 mg for 12 months.
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Leonardo Clavijo
Critical Limb Ischemia and Peripheral Artery Disease
Administration of Adipose-derived Stem Cells (ASC) in Patient With Critical Limb Ischemia.
Different types of stem cells have recently been studied in clinical trial on ischemic disease of the heart and muscular arteries.
- Trial name
- ACellDREAM2 (NCT03968198)
- Testing
- Autologous ASC (for Adipose-derived Stem/Stroma Cell)
- Where
- France
- Volunteers
- 2 people
- Sponsor
- University Hospital, Toulouse
Peripheral Vascular Diseases, Peripheral Arterial Disease
Pilot Study of Topographic Imaging of the Calf Muscle in Patients With PAD Using 3D Reconstruction of MSOT Images
The aim of this explorative pilot study is to present muscle perfusion of the lower extremity in patients with PAD using the Multispectral Optoacoustic Tomography (MSOT) method to build a 3D reconstruction of the calf muscle.
- Trial name
- NCT05110677
- Testing
- Multispectral Optoacoustic Tomography (MSOT)
- Where
- Germany
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- University Hospital Erlangen
Critical Limb Ischemia
Comparison of Cilostazol-based Triple Antiplatelet Therapy Versus Dual Antiplatelet Therapy for Outcomes of below-the Knee Endovascular Intervention in Patients With Critical Limb Ischemia (TAP CLI Study)
Prospective, randomized, controlled, multi-center study A total of 390 subjects with critical limb ischemia will be included according to inclusion and exclusion criteria.
- Trial name
- NCT02829151
- Testing
- Triple antiplatelet therapy (aspirin (100 mg), clopidogrel (75 mg), and cilostazol (200 mg) ), Dual antiplatelet therapy (aspirin (100 mg) and clopidogrel (75 mg)) using aspirin and clopidogrel, Dual antiplatelet therapy (aspirin (100 mg) and cilostazol (200 mg)) using aspirin and cilostazol
- Where
- South Korea
- Volunteers
- 390 people
- Sponsor
- Yonsei University
Critical Limb Ischemia, Critical Lower Limb Ischemia
PROMISE II: 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…
- Conditions
- Critical Limb Ischemia, Critical Lower Limb Ischemia, Peripheral Artery Disease, Peripheral Arterial Disease
- Trial name
- PROMISE (NCT03970538)
- Testing
- LimFlow System
- Where
- 21 sites in United States, Puerto Rico
- Volunteers
- 105 people
- Sponsor
- LimFlow, Inc.
Peripheral Artery Disease, Peripheral Vascular Disease
Safety of Intramuscular Injections (IM) of Allogeneic PLX-PAD Cells for the Treatment of Critical Limb Ischemia (CLI)
The purpose of this study is to determine the safety of PLX-PAD, Intra-muscular injections for the treatment of CLI patients.
- Conditions
- Peripheral Artery Disease, Peripheral Vascular Disease, Critical Limb Ischemia
- Trial name
- NCT00951210
- Testing
- PLX-PAD
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Pluristem Ltd.
Critical Limb Ischemia
Alprostadil as an Adjuvant Therapy With Indirect Angiosomal Revascularization in Critical Limb Ischemia.
The aim of this study is to assess the efficacy of Alprostadil (Prostaglandin E2) as adjuvant therapy after failure of direct but indirect angiosomal revascularization in patients with critical limb ischemia.
- Trial name
- NCT04312555
- Testing
- Alprostadil
- Volunteers
- 30 people
- Sponsor
- Assiut University
Critical Limb Ischemia (CLI), Popliteal Nerve Block
Ultrasound-Guided Sciatic Popliteal Nerve Block vs. Erector Spinae Plane Block in Endovascular Management of CLI
Comparison of popliteal sciatic nerve block and erector spinae plane block (ESPB) in patients undergoing endovascular management of critical lower limb ischemia (CLI).
- Conditions
- Critical Limb Ischemia (CLI), Popliteal Nerve Block, ESPB
- Trial name
- NCT06913348
- Testing
- Popliteal sciatic nerve block
- Where
- Egypt
- Volunteers
- 70 people
- Sponsor
- Minia University Hospital
Critical Limb Ischemia (CLI)
Intra-arterial Infusion of Autologous Bone Marrow Mononuclear Cells in Non-diabetic Patients With Critical Limb Ischemia (CLI).
Phase II Clinical Trial, a prospective, multicenter, open, randomized, parallel-group controlled with three levels of dose. The hypothesis of the test we propose is that the mononuclear cells of bone marrow provide progenitor…
- Trial name
- NCT01408381
- Testing
- Intraarterial Infusion of Autologous Bone Marrow Mononuclear Cells
- Where
- 5 sites in Spain
- Volunteers
- 38 people
- Sponsor
- Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Critical Limb Ischemia, Peripheral Artery Disease
Tack Optimized Balloon Angioplasty Below the Knee (TOBA - BTK) Study
Multi-center study to optimize below the knee (BTK) balloon angioplasty results by creating tissue apposition in peripheral arteries with Reference Vessel Diameter's (RVD) ranging from 1.5mm to 4.5mm.
- Trial name
- TOBABTK (NCT02235675)
- Testing
- Tack-It Endovascular System
- Where
- Austria
- Volunteers
- 35 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Critical Limb Ischemia
An Efficacy and Safety Study of Ixmyelocel-T in Patients With Critical Limb Ischemia (CLI)
This study is designed to evaluate the efficacy and safety of ixmyelocel-T, a patient-specific expanded multicellular therapy, for the treatment of patients with critical limb ischemia (CLI).
- Trial name
- REVIVE (NCT01483898)
- Testing
- Ixmyelocel-T
- Where
- 86 sites in United States
- Volunteers
- 41 people
- Sponsor
- Vericel Corporation
Critical Limb Ischemia
Correlation Between FlowMet™ and Other Gold Standard Assessments in the Management of Critical Limb Ischemia (CLI)
The purpose of this study is to demonstrate the utility of the FlowMet™ device in the assessment of perfusion in subjects suspected of or being treated for critical limb ischemia, in comparison to other gold standard…
- Trial name
- NCT03094559
- Testing
- FlowMet
- Where
- United States
- Sponsor
- The Cleveland Clinic
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.
Critical Limb Ischemia Due to Buerger's Disease
A Clinical Trial to Study the Efficacy and Safety of Stempeucel® in Patients With CLI Due to Buergers Disease
This study is being conducted as an extension of the phase II clinical trial SRPL/CLI/10-11/001 (NCT01484574). The CDSCO has recommended flexibility for continued clinical study in consultation with ICMR, as per recommendation of…
- Trial name
- NCT03056742
- Testing
- Stempeucel(R)
- Where
- 8 sites in India
- Sponsor
- Stempeutics Research Pvt Ltd
Critical Limb Ischemia, Peripheral Vascular Disease
Study of Remodulin in Patients With Critical Limb Ischemia With No Planned Revascularization Procedures
The purpose of this study is to assess and compare the safety of continuous and daily subcutaneous Remodulin therapy in patients with critical limb ischemia (CLI) with no planned vascular interventional procedures; and to…
- Conditions
- Critical Limb Ischemia, Peripheral Vascular Disease, Foot Ulcers, Rest Leg Pain
- Trial name
- NCT00060996
- Testing
- Remodulin® (treprostinil sodium) Injection
- Where
- 7 sites in United States
- Volunteers
- 30 people
- Sponsor
- United Therapeutics
Peripheral Vascular Diseases
A Non-Randomized Study of the NightHawk Peripheral Plaque Excision System During Plaque Excision of Peripheral Arterial Disease
To assess the proximity of the catheter to the vessel wall and to correlate excised tissue with images collected by the integrated Optical coherence Tomography (OCT) imaging system.
- Trial name
- NightHawk (NCT00516308)
- Testing
- NightHawk
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- FoxHollow Technologies