Clinical trials: Chronic Limb-threatening Ischemia
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
Serrantor OCT Study
TA prospective randomized control trial to evaluate the serration angioplasty effect in BTK arteries with varying degrees of calcified plaque.
- Trial name
- NCT06434194
- Testing
- Serranator PTA Serration Catheter, PTA (Standard of Care)
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Cagent Vascular LLC
Aspirin Resistance
Aspirin Resistance and Prognosis of Patients With Critical Limb Ischaemia
Acetylsalicylic acid (Aspirin, ASA) is the most widely prescribed drug used in primary and secondary prevention of cardiovascular disease.
- Trial name
- Aspirine (NCT01104441)
- Where
- 2 sites in France
- Volunteers
- 68 people
- Sponsor
- University Hospital, Limoges
Stenosis, Occlusion
Local Paclitaxel or Balloon Angioplasty Below the Knee
Patients with claudication or critical limb ischemia will be treated either with uncoated balloons or paclitaxel coated balloons in order to enhance the vessel patency in stenosed or occluded below the knee arteries
- Conditions
- Stenosis, Occlusion, Restenosis
- Trial name
- SAMBA (NCT03149913)
- Testing
- SequentPlease OTW paclitaxel coated balloon catheter, conventional uncoated balloon for BTK endovascular therapy
- Where
- 7 sites in Austria, Germany
- Volunteers
- 120 people
- Sponsor
- Prof. Dr. med. Gunnar Tepe
Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia Nos of Native Arteries of Extremities
SELUTION4BTK Trial
This study aims to demonstrate superior efficacy and equivalent safety of the SELUTION SLR™ DEB 014 compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the BTK arteries in…
- Trial name
- NCT05055297
- Testing
- SELUTION SLR™ DEB 014, Plain (Uncoated) Balloon Angioplasty (PTA)
- Where
- 48 sites in United States, Austria and 8 more
- Volunteers
- 376 people
- Sponsor
- M.A. Med Alliance S.A.
Critical Limb Ischemia (CLI)
Expanded Access for Treatment Use of PLX-PAD in Critical Limb Ischemia (CLI)
This is an Expanded Access program (EAP), sponsored by WideTrial for the treatment of critical limb ischemia (CLI). Widetrial, an Expanded Access specialist, has arranged to supply participating sites with PLX-PAD for CLI…
- Trial name
- NCT03746899
- Testing
- PLX-PAD
- Sponsor
- WideTrial, Inc.
Critical Limb Ischemia
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.
- Trial name
- CITRA (NCT04369781)
- Testing
- transcutaneous oxygen pressure recording at rest
- Where
- France
- Volunteers
- 300 people
- Sponsor
- University Hospital, Angers
Lower Limb Ischemia, Peripheral Arterial Disease
The PORTuguese Registry of Supera Supported Femoral-Fopliteal Revascularization (SupPORT Registry)
The SupPORT Registry aims at collecting real-world from Portuguese centers performing femoral-popliteal revascularization with Supera (r) implants. This is a prospective non-randomized non-controlled consecutive registry.
- Conditions
- Lower Limb Ischemia, Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia, Chronic Limb Ischemia
- Trial name
- SupPORT regist (NCT06416644)
- Testing
- Supera Vasculomimetic Stent
- Where
- 15 sites in Portugal
- Volunteers
- 100 people
- Sponsor
- Hospital do Divino Espírito Santo de Ponta Delgada
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
Retrograde Recanalization of Infrainguinal Arterial Occlusive Disease.
The spectrum of lower extremity peripheral arterial disease (PAD) ranges from exhibiting no symptoms to limb threatening gangrene.
- Trial name
- NCT04974905
- Testing
- retrograde access for re-canalization of infra-inguinal arterial occlusive disease
- Volunteers
- 40 people
- Sponsor
- Sohag University
Critical Limb Ischemia
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.
- Trial name
- NCT06191237
- Volunteers
- 30 people
- Sponsor
- University Hospital of Limerick
Chronic Limb Threatening Ischemia
Multimodal Noninvasive Assessment of Peripheral Circulation in Chronic Limb-threatening Ischemia
Assessment of a novel diagnostic method for screening and diagnosing chronic limb-threatening ischemia (CLTI). Using hyperspectral and thermal imaging, the perfusion and oxygenation in the lower limbs will be studied in healthy…
- Trial name
- NCT05786001
- Where
- Finland
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Tampere University
Critical Limb Ischemia (CLI)
Initial Feasibility Study of the STENTiT Resorbable Fibrillated Scaffold (RFS). The RFS is Intended to Restore Lumen Patency and Blood Flow to Infrapopliteal Arteries. The RFS is a Fully Electrospun Tubular Device With a Fibrillated Microarchitecture and Designed for Transcatheter Delivery
This is the First-In-Human feasibility study of the RFS for below the knee lesions in subjects who experience critical limb ischemia due to the peripheral artery disease.
- Trial name
- VITAL-IT 1 (NCT07006467)
- Testing
- Implantation of RFS
- Where
- Austria
- Volunteers
- 10 people
- Sponsor
- Stentit
Chronic Limb-threatening Ischemia, Diabetes Mellitus
Bone Marrow Mononuclear Cells vs Mesenchymal Stem Cells in Diabetic Patients With Chronic Limb Ischemia
Patients in the severe stages of Chronic limb-threatening ischemia (CLTI) are prone to amputation and death, leading to poor quality of life and a great socioeconomic burden.
- Trial name
- NCT05631444
- Testing
- Cell-based therapy
- Where
- Colombia
- Volunteers
- 24 people
- Sponsor
- Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
Peripheral Vascular Diseases, Arterial Occlusive Diseases
Intra-arterial Stem Cell Therapy for Patients With Chronic Limb Ischemia (CLI)
The purposes of this study are to determine whether intra-arterial injection of autologous stem cells is effective in the treatment of chronic limb ischemia (CLI), to characterize stem cell dysfunction in patients with CLI, and…
- Conditions
- Peripheral Vascular Diseases, Arterial Occlusive Diseases, Leg Ulcer, Gangrene
- Trial name
- JUVENTAS (NCT00371371)
- Testing
- Bone marrow punction, BM-MNC infusion
- Where
- Netherlands
- Volunteers
- 160 people
- Sponsor
- UMC Utrecht
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
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
Diabetes Mellitus, Claudication, Intermittent
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…
- Conditions
- Diabetes Mellitus, Claudication, Intermittent, Critical Limb Ischemia, Osteomyelitis
- Trial name
- AHOLEA (NCT03594344)
- Testing
- Hyperbaric oxygen therapy
- Where
- 2 sites in Norway
- Volunteers
- 120 people
- Sponsor
- Oslo University Hospital
Critical Limb Ischemia, Peripheral Arterial Disease
Safety and Efficacy Study of Autologous BM-MNC Processed by Two Methods for Treating Patients With Chronic Limb Ischemia
Using autologous bone marrow mononuclear cells (BM-MNC) to treat patients with chronic limb ischemia has been proved safe and effective.
- Conditions
- Critical Limb Ischemia, Peripheral Arterial Disease, Buerger's Disease
- Trial name
- NCT01446055
- Testing
- ResQ processed bone marrow sample, Ficoll conventional cell processing method
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Xuanwu Hospital, Beijing
Critical Limb Ischemia
Safety Study of UT-15C SR (Oral Treprostinil) in Patients Undergoing a Lower Limb Endovascular Procedure
In chronic CLI patients who are appropriate candidates for endovascular procedures - and many patients are not because of their advanced age and disease state - the treatment regimen may include endovascular procedures such as…
- Trial name
- NCT00651885
- Testing
- treprostinil dienthanolmine sustained release
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Ochsner Health System