Clinical trials: Critical Limb Ischemia
Peripheral Arterial Occlusive Disease, Chronic Limb-Threatening Ischemia
Safety of Antithrombotic Heparin Proteoglycan Mimetic APAC in Peripheral Arterial Occlusive Disease and Chronic Limb-threatening Ischemia
The goal of this study is to learn if a new medicine (called antiplatelet and anticoagulant [APAC]) can help the body to prevent blood clots and whether APAC is safe and well tolerated in patients with blocked or narrowed…
- Trial name
- HEALING (NCT07352800)
- Testing
- APAC - dose level 0.50 mg/kg,, Unfractionated heparin (UFH), APAC dose level 1: 0.25 mg/kg,
- Where
- 3 sites in Finland
- Volunteers
- 42 people
- Sponsor
- Aplagon Oy
Chronic Total Occlusion of Artery of the Extremities
FastWire REvascularisation of Extremities, (For LOWer Limbs) - FREEFLOW
This study is to assess the safety and efficacy of the FastWire System. It is intended to assess that the FastWire System can facilitate the intra-luminal placement of conventional guidewires or treatment devices beyond…
- Trial name
- NCT06492733
- Testing
- FastWire System - Peripheral
- Where
- 6 sites in United States
- Volunteers
- 65 people
- Sponsor
- Versono Medical Ltd
Critical Limb Ischemia
Registry of First-line Treatments in Patients With Critical Limb Ischemia
The principal research question is which treatment modality between open surgical, endovascular and conservative therapy is the most effective in terms of limb salvage, survival and reinterventions in patients with critical limb…
- Trial name
- CRITISCH (NCT01877252)
- Testing
- Surgical revascularization, Endovascular revascularization, No vascular intervention
- Where
- Germany
- Volunteers
- 1,200 people
- Sponsor
- St. Franziskus Hospital
Peripheral Artery Disease
Home-based Exercise Therapy in Patients With Moderate to Severe Peripheral Artery Disease
Peripheral arterial disease (PAD) is a chronic atherosclerotic condition associated with impaired mobility, reduced quality of life, cardiovascular events, and risk of lower limb amputation.
- Trial name
- PILOT-PADCYCLE (NCT07655206)
- Testing
- Home-Based Exercise Therapy Using Portable Pedal Exerciser
- Where
- Canada
- Volunteers
- 12 people
- Sponsor
- Laval University
Peripheral Artery Disease Without Critical Limb Ischemia
Non-Healing Ulcers Without Critical Limb Ischemia
Background: Lower limb arterial revascularization procedures, either percutaneously or surgically performed, are an established treatment modality of ischemic foot ulcers, especially in the setting of a critical limb ischemia.
- Trial name
- NEWLI (NCT01666093)
- Testing
- Angioplasty of the lower limbs vessels
- Where
- Switzerland
- Volunteers
- 30 people
- Sponsor
- University Hospital, Geneva
Peripheral Arterial Disease
Autologous CD133(+) Cells as an Adjuvant to Below the Knee Percutaneous Transluminal Angioplasty
The main aim of the present study was to evaluate the therapeutic potential and safety of transarterial infusion of granulocyte colony stimulating factor (G-CSF) mobilized cluster of differentiation (CD) 133(+) cells when…
- Trial name
- NCT02915796
- Testing
- G-CSF + CD133(+) cells, G-CSF, percutaneous transluminal angioplasty (PTA)
- Where
- China
- Volunteers
- 345 people
- Sponsor
- Shanghai 10th People's Hospital
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
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
Intermittent Claudication, Peripheral Vascular Diseases
Autologous Bone Marrow-derived Mononuclear Cells for Therapeutic Arteriogenesis in Patients With Limb Ischemia
The investigators propose confirm and extend the findings of open studies on the apparent efficacy of bone-marrow derived mononuclear cells for the induction of arteriogenesis in patients with severe claudication or critical leg…
- Trial name
- ABC (NCT00539266)
- Testing
- bone marrow derived mononuclear cells
- Where
- Netherlands
- Volunteers
- 108 people
- Sponsor
- Leiden University Medical Center
Patients With Symptomatic Critical Limb Ischemia, Severe Intermittent Claudication
Self Expanding Nitinol Stent Versus Percutaneous Transluminal Arterial Angioplasty (PTA) With Optional Bailout Stenting in Case of PTA Failure in Patients With Symptomatic Critical Limb Ischemia or Severe Intermittent Claudication (EXPAND)
The clinical investigation is a prospective, international, multi-centre, randomized (1:1) trial with follow up investigations at 1, 3, 6 and 12 months.
- Trial name
- EXPAND (NCT00906022)
- Testing
- Astron Pulsar Stent, PTA alone
- Where
- Germany
- Volunteers
- 94 people
- Sponsor
- Biotronik AG
Mechanical Ventilation Complication, Arterial Thrombosis
Pragmatic Randomized Trial for Arterial Catheters in the Critical Care Environment
Investigators will conduct a pragmatic randomized trial to investigate the non-inferiority of restricted use of invasive arterial lines compared to standard arterial line use.
- Conditions
- Mechanical Ventilation Complication, Arterial Thrombosis, Limb Ischemia, Shock
- Trial name
- GRACE (NCT05411315)
- Testing
- Restricted-use of arterial catheter, Standard-use of arterial catheter
- Where
- United States
- Volunteers
- 700 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
Critical Limb Ischemia
Switch to Ticagrelor in Critical Limb Ischemia Anti-platelet Study
Critical Limb Ischemia (CLI) is defined as limb pain that occurs at rest, or impending limb loss that is caused by severe compromise of blood flow to the affected extremity.
- Trial name
- STT-CLIPS (NCT02091921)
- Testing
- Ticagrelor
- Where
- United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- University of Southern California
Critical Limb Ischemia, Peripheral Arterial Disease
Foot Perfusion Analysis to Predict Limb Salvage
This study aims at evaluating the correlation between foot perfusion on angiographies performed before and after revascularization and limb salvage in patients with critical limb ischemia.
- Trial name
- DELTA-PERF (NCT03810469)
- Where
- France
- Volunteers
- 69 people
- Sponsor
- Centre Hospitalier de Valenciennes
Peripheral Arterial Disease, Cardiovascular Diseases
Allogeneic Mesenchymal Stromal Cells for Angiogenesis and Neovascularization in No-option Ischemic Limbs
The primary objective of this trial is to investigate whether intramuscular administration of allogeneic mesenchymal stromal cells (MSC) is safe and potentially effective, assessed as a composite outcome of mortality, limb…
- Conditions
- Peripheral Arterial Disease, Cardiovascular Diseases, Vascular Diseases
- Trial name
- SAIL (NCT03042572)
- Testing
- Allogeneic Mesenchymal Stromal Cell
- Where
- Netherlands
- Volunteers
- 60 people
- Sponsor
- Martin Teraa, MD, PhD
Chronic Limb-Threatening Ischemia
Bioresorbable Sirolimus-Eluting Scaffold Treatment for Below the Knee Disease
The objective of this prospective, single-blinded, randomized controlled trial is to evaluate the safety and efficacy of the MAGNITUDE BRS System for the planned treatment of narrowed infrapopliteal lesions.
- Trial name
- ELITE-BTK (NCT06071429)
- Testing
- MAGNITUDE Sirolimus-eluting Bioresorbable Scaffold, Percutaneous Transluminal Angioplasty (PTA)
- Where
- 3 sites in United States
- Volunteers
- 300 people
- Sponsor
- R3 Vascular Inc.
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 (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
Critical Limb Ischemia
Intramuscular Mononuclear Cells and Mesenchymal Stem Cells Transplantation to Treat Chronic Critical Limb Ischemia
This is a randomized and single blinded study aimed to compare the efficacy between intramuscular autologous bone marrow mononuclear cells plus mesenchymal stem cell implantation and intramuscular autologous bone marrow…
- Trial name
- NCT01456819
- Testing
- Mononuclear and mesenchymal stem cells, Mononuclear cells
- Where
- Malaysia
- Volunteers
- 50 people
- Sponsor
- National University of Malaysia
Lower Limb Ischemia, Peripheral Vascular Diseases
An Efficacy and Safety Study to Evaluate Ranger DEB for BTK Angioplasty in Patients With CLI (RANGER-BTK)
Endovascular treatment of below the knee disease is a well-established therapy to improve outcomes in patients with critical limb ischemia.
- Trial name
- RANGER-BTK (NCT02856230)
- Testing
- Ranger SL DEB
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris