Clinical trials: Critical Ischemia Limb
Stable Coronary Artery Disease, Acute Coronary Syndromes
Local And Systemic Macrophage Activation in Coronary and Peripheral Artery Disease
Numerous clinical studies have highlighted the role of macrophages in the destabilization of coronary lesions; however, there is limited literature on the relationship between circulating monocytes and intraplaque macrophages.
- Conditions
- Stable Coronary Artery Disease, Acute Coronary Syndromes, Critical Limb Ischemia, Intermittent Claudication
- Trial name
- NCT07588295
- Testing
- Optical Coherence Tomography assessment
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- Maria Cecilia Hospital
Peripheral Arterial Disease, Peripheral Vascular Disease
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…
- Conditions
- Peripheral Arterial Disease, Peripheral Vascular Disease, Critical Limb Ischemia
- Trial name
- PRIME (NCT02786173)
- Where
- 6 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Metro Health, Michigan
Critical Limb Ischemia
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…
- Trial name
- NCT06359912
- Testing
- EPCs, Clinical standard treatment (CST)
- Where
- China
- Volunteers
- 27 people
- Sponsor
- Allife Medical Science and Technology Co., Ltd.
Critical Limb Ischemia, Peripheral Arterial Disease - PAD
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…
- Conditions
- Critical Limb Ischemia, Peripheral Arterial Disease - PAD, Ischemic Ulcer, Ischemic Feet
- Trial name
- NCT04746599
- Testing
- Autologous Fat Grafting
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Critical Limb Ischemia (CLI)
LIFE-BTK Randomized Controlled Trial
The objective of this prospective, single-blinded, randomized controlled clinical investigation is to evaluate the safety and efficacy of the everolimus eluting Esprit BTK System for the planned treatment of narrowed…
- Trial name
- LIFE-BTK (NCT04227899)
- Testing
- Esprit BTK Device, Percutaneous Transluminal Angioplasty (PTA) Device
- Where
- 50 sites in United States, Australia and 4 more
- Volunteers
- 261 people
- Sponsor
- Abbott Medical Devices
Abdominal Aortic Aneurysm, Carotid Atherosclerosis
Preconditioning Shields Against Vascular Events in Surgery
Major vascular surgery involves operations to repair swollen blood vessels, clear debris from blocked arteries or bypass blocked blood vessels.
- Conditions
- Abdominal Aortic Aneurysm, Carotid Atherosclerosis, Critical Lower Limb Ischaemia
- Trial name
- SAVES (NCT01691911)
- Testing
- Remote preconditioning
- Where
- Ireland
- Volunteers
- 200 people
- Sponsor
- Mid Western Regional Hospital, Ireland
Critical Limb Ischemia, Peripheral Arterial Disease
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…
- Trial name
- NCT05854641
- Testing
- Stempeucel®
- Where
- Malaysia
- Volunteers
- 10 people
- Sponsor
- Cell Biopeutics Resources Sdn Bhd
Peripheral Vascular Diseases
DEB ( Drug Eluting Balloon) in Crural Arteries and Critical Limb Ischemia
The purpose of this trial is to compare short- medium long-term results in treatment of PAD (peripheral arterial disease) in the crural arteries with either drug coated balloon or conventional balloons in a prospective …
- Trial name
- NCT02750605
- Testing
- DEB, POBA
- Where
- Sweden
- Volunteers
- 70 people
- Sponsor
- Skane University Hospital
Peripheral Arterial Disease
Singapore INfra-Genicular Angioplasty With PAclitaxel-eluting Balloon for Critical Limb Ischaemia (SINGA-PACLI) Trial
Background In patients with critical limb ischaemia (CLI), the infragenicular arteries are often involved. Without revascularisation, amputation often is imperative.
- Trial name
- SINGA-PACLI (NCT02129634)
- Testing
- CB-PTA, DEB-PTA
- Where
- 2 sites in Singapore
- Volunteers
- 136 people
- Sponsor
- Singapore General Hospital
Critical Limb Ischemia, Peripheral Arterial Disease
Safety and Efficacy Study of Autologous Concentrated Bone Marrow Aspirate (cBMA) for Critical Limb Ischemia (CLI)
This trial will evaluate the safety and efficacy of concentrated bone marrow aspirate (cBMA) to prevent or delay major amputation and/or death in subjects with critical limb ischemia (CLI) due to severe peripheral arterial…
- Conditions
- Critical Limb Ischemia, Peripheral Arterial Disease, Peripheral Vascular Disease
- Trial name
- MOBILE (NCT01049919)
- Testing
- Bone marrow concentration device
- Where
- 25 sites in United States
- Volunteers
- 153 people
- Sponsor
- Zimmer Biomet
Critical Limb Ischemia
Investigating the Safety and Efficacy of the Treatment With the Selution Sirolimus Coated Balloon in TASC C and D Tibial Occlusive Disease in Patients With Critical Limb Ischemia From Singapore
The objective of this clinical investigation is to evaluate the 6-month outcome of the Selution Sirolimus-coated Balloon for the treatment of long tibial occlusive disease (TASC C and D) in patients with Critical Limb Ischemia…
- Trial name
- PRESTIGE (NCT04071782)
- Testing
- Drug Coated Balloon
- Where
- Singapore
- Volunteers
- 25 people
- Sponsor
- Singapore General Hospital
Chronic Limb-threatening Ischemia, Endovascular Therapy
Prospective Multicenter Registry on the Endovascular Treatment in Critical Limb Threatening Ischemia With Below the Knee Lesions With Wound, Ischemia, and Foot Infection (WIFI) Assessment
This is a prospective multicenter clinical study that used WIFI grading scores at different periods to evaluate the therapeutic value of endovascular therapy and this grading system for Chronic limb-threatening ischemia.
- Trial name
- NCT04710420
- Testing
- Endovascular therapy
- Where
- China
- Volunteers
- 842 people
- Sponsor
- Xuanwu Hospital, Beijing
Critical Limb Ischemia (CLI)
Clinical Trial I/II Opened, Randomized and Controlled for the Study of the Use of Stem Cells Therapy in Insulinized Diabetic Patients Type 2 With Critical Ischemia in Lower Limbs (CLI): Study of the Needs of Insulin
To study the effect of the stem cells therapy autologous mononuclear from the bone marrow, autologous progenitor endothelial CD133 cells from the bone marrow and autologous mesenchymal stem cells from adipose tissue on the…
- Trial name
- NCT02287974
- Testing
- Stem cell infusion
- Where
- 2 sites in Spain
- Volunteers
- 20 people
- Sponsor
- Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Peripheral Arterial Disease, Leg Ulcer
Cell Therapy for Lower Limb Ulcers in Patients With Critical Limb Ischemia
Peripheral arterial disease (PAD) can progress to critical limb ischemia (CLI) of the affected lower limb, characterized by pain at rest, ulcerations or gangrene, with a high risk of amputation.
- Trial name
- NCT06326203
- Testing
- CELULAS TRONCO, CONVENTIONAL DRESSING
- Volunteers
- 40 people
- Sponsor
- UPECLIN HC FM Botucatu Unesp
Critical Limb Ischemia (CLI)
LIFE-BTK PK Sub-study
LIFE-BTK PK is a prospective, single-arm, open-label, non-blinded, non-randomized sub-study of LIFE-BTK Randomized Controlled Trial (NCT04227899), that will enroll approximately 7 subjects in the United States (US) and outside…
- Trial name
- NCT05208905
- Testing
- Esprit BTK Device
- Where
- 5 sites in United States, Australia and 1 more
- Volunteers
- 9 people
- Sponsor
- Abbott Medical Devices
Critical Ischemia Limb
NOrmoBaric Oxygen Therapy Use In Critical Limb ISchemia
Peripheral arteriopathy disease (PAD) affects 1 million people in France. In its most advanced stage: chronic permanent ischemia also called critical ischemia, the prognosis of patients is burdened with a one-year mortality rate…
- Trial name
- NOBILIS (NCT06238050)
- Testing
- introduction of oxygen therapy or not
- Where
- 3 sites in France
- Volunteers
- 200 people
- Sponsor
- University Hospital, Angers
Critical Limb Ischemia
The DES BTK Vascular Stent System vs PTA in Subjects With Critical Limb Ischemia
Single 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.
- Trial name
- SAVAL (NCT03551496)
- Testing
- Drug Eluting Stent - Below the Knee, Standard PTA Control Arm
- Where
- 42 sites in United States, Belgium and 3 more
- Volunteers
- 201 people
- Sponsor
- Boston Scientific Corporation
Peripheral Artery Disease, Intermittent Claudication
Assessing Best Medical Treatment Patterns of Patients With Symptomatic Peripheral Arterial Occlusive Disease in Germany
This proposed study will be conducted to support real-world-evidence on the extent of best medical treatment for secondary prevention of patients with symptomatic peripheral arterial occlusive disease (PAOD) for prevention of…
- Conditions
- Peripheral Artery Disease, Intermittent Claudication, Critical Limb Ischemia
- Trial name
- NCT03909022
- Volunteers
- 60,000 people, healthy volunteers welcome
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
Peripheral Vascular Disease, Critical Limb Ischemia
Near Infrared Spectroscopy and Transcutaneous Oxygen Pressure in Critical Limb Ischemia Before and After Treatment
Comparison of two non-invasive methods for measuring tissue oxygenation. One is Transcutaneous Oxygen Pressure (TCPO2) and the other is the new method of Near Infrared Spectroscopy (NIRS) - near infrared spectroscopy in patients…
- Trial name
- NIRS (NCT01459341)
- Where
- Israel
- Volunteers
- 15 people
- Sponsor
- Carmel Medical Center
Symptomatic Peripheral Artery Disease With Femoropopliteal Lesions, Moderate or Severe Claudication (Rutherford Category 2 or 3)
Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease
Prospective, multi-center single-arm observational study A total of 100 subjects with femoropopliteal artery disease who meet all inclusion and exclusion criteria will be included.
- Conditions
- Symptomatic Peripheral Artery Disease With Femoropopliteal Lesions, Moderate or Severe Claudication (Rutherford Category 2 or 3), Critical Limb Ischemia (Rutherford Category 4 or 5)
- Trial name
- K-ELUVIA (NCT06234280)
- Testing
- Implantation of Eluvia stent
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Yonsei University